Sadraj/Contents

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Uvod
Introduction
ALIMS - organizacija koja se kontinuirano razvija i unapreuje...............................................
4
ALIMS - an organization that is continually evolving and improving.................................................
2.1. Misija i vizija ALIMS...............................................................................................................
5
2.1. Mission and Vision of ALIMS.........................................................................................................
2.2. Organizacija ALIMS...............................................................................................................
7
2.2. ALIMS Organization.........................................................................................................................
2.3. Istorijat i povereni poslovi....................................................................................................
9
2.3. Background and entrusted activities...........................................................................................
2.4. Ljudski resursi........................................................................................................................
12
2.4. Human Resources............................................................................................................................
2.5. Meunarodna saradnja i lanstvo u meunarodnim organizacijama.....................
13
2.5. International cooperation and membership in international organizations.....................
2.6. Ciljevi razvoja..........................................................................................................................
18
2.6. Development Goals ......................................................................................................................
Regulatorna performansa ALIMS......................................................................................................
20
ALIMS Regulatory Performance....................................................................................................................
3.1. Predregistracione aktivnosti................................................................................................
21
3.1. Pre-registration activities................................................................................................................
3.2. Medicinska sredstva.............................................................................................................
25
3.2. Medical devices.................................................................................................................................
3.3. Veterinarski lekovi.................................................................................................................
27
3.3. Veterinary medicines.......................................................................................................................
3.4. Postregistracione aktivnosti: farmakovigilanca, informacije o lekovima,
praenje potronje i prometa, oglaavanje..................................................................... 28
3.4. Post-registration activities: pharmacovigilance, information about medicines,
monitoring of consumption and trade, advertising.................................................................
3.5. Klinika ispitivanja.................................................................................................................
34
3.5. Clinical trials.......................................................................................................................................
Laboratorijska kontrola kvaliteta.......................................................................................................
36
Laboratory quality control...............................................................................................................................
Upravljanje kvalitetom u ALIMS.........................................................................................................
40
Quality Management in ALIMS.....................................................................................................................
Struni skupovi u organizaciji ALIMS - edukacija strune javnosti..........................................
43
Professional meetings organized by ALIMS - education of expert public.........................................
Publikacije ALIMS...................................................................................................................................
45
ALIMS Publications...........................................................................................................................................
Internet stranica ALIMS........................................................................................................................
47
ALIMS Website..................................................................................................................................................

1. Uvod

roz vreme, glavno opredeljenje oveka je njegova

briga za zdravlje i ivot, pa mu je u borbi za
opstanak to bilo pokreta da ih sauva. Rezultat
toga je razvoj lekova, kao i medicinskih sredstava u cilju
leenja ili spreavanja bolesti, odnosno ouvanja ivota
kod ljudi i ivotinja.
Sada, brigu za ouvanje zdravlja i ivota delom preuzima
Agencija za lekove i medicinska sredstva Srbije - ALIMS
koja u skladu sa Zakonom o lekovima i medicinskim
sredstvima (Slubeni glasnik RS, br. 30/2010 i 107/2012) i
propisima donetim za njegovo sprovoenje, usaglaenim
sa zahtevima i standardima Evropske unije donosi odluke o potvrdi kvaliteta, bezbednosti i
efikasnosti lekova i medicinskih sredstava.
Ozbiljnost i posveenost sa kojom svi zaposleni u Agenciji pristupaju svojim radnim zadacima je
u skladu sa nivoom odgovornosti u donoenju navedenih odluka Agencije. Takoe, u propisanoj
kontroli kvaliteta lekova i medicinskih sredstava Agencija svakodnevno donosi odluke da li se
ispunjavaju standardi u odnosu na njihov kvalitet, a koji su i standardi najrazvijenih zemalja sveta,
kojima se obezbeuje sigurnost u primeni i korienju ovih proizvoda.
Uspostavljeni sistem Agencije, testiran i u pojedinim tekim okolnostima pokazao je da graani
Srbije mogu da imaju poverenje u odluke Agencije u odnosu na lekove i medicinska sredstva koja
se nalaze na njenom tritu.
Posebna aktivnost Agencije je praenje ivota leka na tritu i eventualno preduzimanje korektivnih
mera kako je to predvieno naim propisima u oblasti farmakovigilance, koji su takoe usklaeni
sa najnovijim EU standardima.
U izvravanju svojih poslova Agencija odrava stalnu saradnju sa nadlenim dravnim organima,
fakultetima, profesionalnim udruenjima lekara, farmaceuta, stomatologa i veterinara, udruenjima
pacijenata, medijima i optom i strunom javnou.
Takoe, Agencija u izvravanju svojih poslova razvija visok nivo regionalne i meunarodne
saradnje, a ima i podrku u svom razvoju od strane referentnih organizacija u Evropi i Svetu, to
se ogleda i kroz vei broj projekata i postojanje meunarodnih ugovora u oblastima iz nadlenosti
Agencije.
Stavljanjem u promet lekova i medicinskih sredstava za koje su u propisanim postupcima dokazani
kvalitet, bezbednost i efikasnost, su osnovni principi Agencije, kako bi se ostvarili ciljevi u odnosu
na ouvanje zdravlja, produenje ivota i obezbeenje njegovog kvaliteta.

Direktor

Spec. dr. med. Saa Jaovi

1. Introduction

hrough time, the main orientation of man is his concern for his health and life, so in his
struggle for survival this determination was a driving force to preserve them. The result
of this is the development of medicines and medical devices, in order to treat or prevent
diseases, or preserve life in humans and animals.
Now, obligation to preserve the health and life is taken in part by Medicines and Medical Devices
Agency of Serbia - ALIMS, that in accordance with the Law on Medicines and Medical Devices
(Official Gazette of RS, no. 30/2010 and 107/2012) and regulations adopted for its execution
complies with the requirements and standards of the European Union gives decission to confirm
the quality, safety and efficacy of medicines and medical devices.
Seriousness and commitment with which all employees shall approach their work tasks in
accordance with the level of responsibility in making these decisions by the Agency. Also, in
the prescribed quality control of medicines and medical devices the Agency makes decisions
every day in order to check if the standards in relation to their quality are met and these are the
standards of most developed countries in the world, to ensure the security of the application of
these products.
The system established in the Agency was tested in some difficult circumstances and showed
that Serbian citizens can have trust in the Agencys decision in relation to medicines and medical
devices that are within its market.
A specific activity of the Agency is following the life cycle of the drug on the market and possibly
taking corrective measures as provided in our regulations in the field of pharmacovigilance, that
are also in compliance with the latest EU standards.
In carrying out its duties the Agency maintains permanent cooperation with state authorities,
universities, professional associations of doctors, pharmacists, dentists, veterinarians, patient
organizations, the media and the general and professional public.
Also, the Agency in carrying out its duties develops a high level of regional and international
cooperation, and has support in its development by reference organization in Europe and the world,
which is also reflected in a number of projects and the existence of international agreements in
the areas the Agency is in charge of.
Putting on the market medicines and medical devices for which quality, safety and efficiency are
proved by prescribed procedures are the basic principles of the Agency, in order to achieve the
objectives in relation to the preservation of health, extending life and securing its quality.

Managing Director

Sasa Jacovic, M. D., sp.

2. ALIMS - organizacija koja

se kontinuirano razvija
i unapreuje
2. ALIMS an organization
which is continually
developing and improving

5
2.1. Misija i vizija ALIMS

2.1. Mission and vision

of ALIMS

Naa misija je da doprinesemo ostvarivanju

osnovnog ljudskog prava za pristup kvalitet
nim, bezbednim i efikasnim lekovima i medi
cinskim sredstvima, kao i da promoviemo i
unapredimo zdravlje ljudi i ivotinja kroz:
izdavanje dozvola za stavljanje u promet
iskljuivo kvalitetnih, bezbednih i efikasnih
lekova i medicinskih sredstava,
pruanje adekvatnih informacija, kako bi
upotreba tih lekova i medicinskih sredsta
va bila bezbedna i racionalna i
kontrolu kvaliteta lekova i medicinskih
sredstava, koja je u potpunosti usaglaena
sa svim nacionalnim i meunarodnim za
konima i standardima.

Our mission is to contribute to the accompli

shment of the basic human right for quality,
efficacious and safe medicines and medical
devices accessibility as well as to promote and
enhance public and animal health through:
Issuing marketing authorizations of solely quality, safe and efficacious medicinal
products and medical devices,
Providing adequate information in order to
ensure a safe and rational use of such me
dicinal products and medical devices, and
Quality control of medicines and medical
devices which is in full compliance with all
the national and international laws and
standards.

Naa vizija je da budemo moderna, efikasna

i drutveno odgovorna institucija, koja e po
stati lider u regionu jugoistone Evrope.

Our vision is to be a modern, efficient and

socially responsible institution which is to
become a leading one in the SEE region.

6
Nau viziju emo ostvariti kroz efektivne i efi
kasne procese u okviru sistema menadmen
ta kvalitetom, usaglaenog sa zahtevima ISO
9001:2008, tako to emo:
uspostavljati i odravati visoke standar
de u postupku evaluacije dokumentacije,
kontoli kvaliteta i pruanju adekvatnih
informacija,
kontinuirano uiti i razvijati kompetent
nosti,
kontinuirano poboljavati sistem menad
menta kvalitetom,
izgraditi jaku organizacionu kulturu i pre
poznatljiv imid,
imati lidersku ulogu rukovodstva u ostva
renju vizije.

We shall accomplish our vision through the

effective and efficacious processes of the quality
management system which is in conformity
with the ISO 9001:2008 requirements, through:
Establishment and maintenance of high
level standards in a documentation evaluation procedure and quality control, and
providing of adequate information,
Continual studies and competence develo
pment,
Continuous quality management system
improvement,
Development of a strong organizational
culture and recognizable image,
Having a leading role of the management
in the vision accomplishment.

Osnovne vrednosti

Basic values

Mi verujemo da svojom snagom moemo da

odgovorimo na sve izazove. Na rad je za
snovan na etiri osnovna principa:
drutvena odgovornost kao institucija
na prvom mestu i u najveoj meri posveeni
smo ouvanju zdravlja ljudi i ivotinja, tako
da sav svoj rad, strunu i naunu kompe
tentnost posveujemo pacijentima u Srbiji.
Odgovorni smo prema drutvenoj zajedni
ci, korisnicima naih usluga, zaposlenima i
osnivaima.
liderstvo opredelili smo se da svojim
radom postavljamo visoke standarde, da
unapreenjem znanja i vetina budemo
oslonac svim zainteresovanim stranama,
kada je javno zdravlje u pitanju, kao i da
modernim rukovoenjem osiguramo pot
puno ostvarenje vizije.
poverenje na dalji razvoj zasnovan je
na unapreenju meusobnog poverenja sa
naim klijentima, kroz zajedniki rad i tran
sparentnost u radu, kao i na jaanju pove
renja u nas same, odnosno u nae zapo
slene.
kvalitet posveeni smo dostizanju naj
vieg kvaliteta naih usluga, kako bi se
ostvarila dodatna vrednost za nae kori
snike, partnere i zaposlene.

We believe we can meet all the challenges with

our strength and stamina. Our performance
is based on four basic principles:
Social responsibility as an institution
we are firstly and mostly dedicated to human and animal health protection so all
our work, professional and scientific competence are devoted to patients in Serbia.
We are responsible to our social environment, users of our services, employees
and founders.
Leadership we committed ourselves to
setting high standards by our operation,
to becoming a support to all the interested
parties in respect of public health through
knowledge and skills enhancement, as
well as to ensuring a complete vision accomplishment by modern management.
Trust our further development is based
on enhancement of mutual trust between
us and our clients through joint performance and work transparency as well as
on strengthening the belief in ourselves,
i.e. our employees.
Quality we are devoted to achieving the
highest quality of our services so the additional value for our clients, partners and
employees can be accomplished.

7
2.2. Organizacija ALIMS

2.2. ALIMS Organization

Organizacija ALIMS prilagoena je poslov

nim procesima i predstavlja modernu struk
turu, funkcion
alnog tipa. Stoga su regulator
ni poslovi stavljanja u promet lekova i me
dicinskih sredstava organizovani u Centru
za humane lekove, Sektoru za medicinska
sredstva i veterinarskom sektoru a labo
ratorijska kontrola kvaliteta u Nacion
alnoj
kontrolnoj laboratoriji (NKL). U ALIMS-u jo
postoje i Nacionalni centar za informacije
o lekovima i medicinskim sredstvima (NCI)
i Nacionalni centar za farmakovigilancu
(NCF), dok poslove upravljanja kvalitetom
za itav ALIMS organizuje i koordinira di
rektor upravljanja kvalitetom. Realizaciju
regulatornih poslova prate i podravaju or
ganizacione celine objedinjene u Centar za
podrku.

ALIMS organization is adapted to the business processes and is a modern structure,

of a functional type. Therefore, the regulatory
jobs of medicines and medical devices registration are organized at the Human Medicines
Centre, Medical Devices Department and
Veterinary Medicines Department and laboratory quality control at the National Control
Laboratory (NCL). In ALIMS there is also the
National Centre for Information on Medicines
and Medical Devices (NCI) and the National
Pharmacovigilance Centre (NPC) while the
quality management activities for the whole
ALIMS are organized and coordinated by the
Quality Management Manager. Implementation of regulatory affairs are monitored and
supported by organizational units combined
in the Centre for Support.

Direktor
Managing director
Kancelarija direktora
Managing Director Office

Nacionalna kontrolna
laboratorija
National Control
Laboratory
Fiziko-hemijska
laboratorija
Physico-Chemical
Laboratory
Bioloka laboratorija
Biological Laboratory
Odeljenje za upravljanje
kvalitetom i podrku
Quality Managment
and Support Unit

Nacionalni centar za informacije

o lekovima i medicinskim sredstvima
National Centre for Information
on Medicines and Medical Devices

Direktor upravljanja kvalitetom

QM Manager

Centar za
humane lekove
Human Medicines
Centre
Sektor za stavljanje u
promet humanih lekova
Licencing Department
Sektor za procenu
dokumentacije o leku
Assessment Department
Farmaceutski sektor
Pharmaceutical
Department
Medicinski sektor
Medical Department
Nacionalni centar
za farmakovigilancu
National
Pharmacovigilance
Centre

Centar za podrku
Centre for Support
Finansijski sektor
Financial Department
Odsek za raunovodstvo
Accounting Department
Odsek za komercijalne
poslove
Department of
Commercial Affairs

Administrativni sektor
Administrative Department
Sluba za prijem zahteva
iz nadlenosti Agencije i
poslove pisarnice
Receipt and Issuing
Affairs
Odeljenje za prave i
opte poslove
Legal and General
Affairs

Grupa za informacionu
tehnologiju
IT Group

Veterinarski sektor
Veterinary Medicines
Department

Sektor za
medicinska sredstva
Medical Devices
Department

8
Upravni organi Agencije su Upravni odbor
i direktor. Upravni odbor ima predsednika
i etiri lana, od kojih se jedan bira iz reda
zaposlenih u Agenciji.
U okviru Agencije takoe funkcioniu Komi
sije koje ine eksperti, saradnici Agencije i
to su:
Komisija za stavljanje u promet humanih
lekova
Komisija za stavljanje u promet veterinarskih
lekova
Komisija za medicinska sredstva
Komisija za procenu klinikih ispitivanja
humanih lekova
Komisija za procenu bezbednosti lekova
Komisija za farmakovigilancu veterinarskih
lekova
Komisija za procenu klinikih ispitivanja
veterinarskih lekova
Pored ovoga, ALIMS u pojedinim pitanjima
strune procene koristi i usluge spoljnih
eksperata, najeminentnijih strunjaka u
naoj zemlji za pojedine oblasti medicine i
farmacije. Konano, ALIMS je bio i domain
drugim telima kao to je Komisija Evropske
farmakopeje (na slici).

Managing bodies of the Agency are a Managing Board and managing director. The
Managing board has a chairman and four
members, one of whom is chosen among the
Agency employees.
Within the Agency also operate Commi
ssions, which are made by experts, collaborators of the Agency and these are:
Committee for Marketing Authorization of
Human Medicines
Committee for Marketing Authorization of
Veterinary Medicines
Committee for Medical Devices
Committee for Human Medicines Clinical
Trials Assessment
Committee for Medicines Safety Assessment
Committee for Veterinary Medicines Pharmacovigilance
Committee for Veterinary Medicines Clinical
Trials Assessment
In addition, in certain matters of expert evaluation ALIMS uses services of external experts,
the most eminent experts in our country in
certain areas of medicine and pharmacy. Finally, ALIMS was the host of other bodies,
such as the European Pharmacopoeia Commission (on the picture).

9
2.3. Istorijat
i povereni poslovi

2.3. Background
and entrusted activities

Ve 1948. godine, pri Saveznom organu upra

ve Jugoslavije, zaduenom za poslove zdrav
stva, osnovan je Savezni zavod za koji se
pored lekova bavio i ispitivanjem i kontrolom
seruma i vakcina, ali i kozmetike, dijetetskih
proizvoda, medicinske opreme, i svih dru
gih materijala koji slue u medicinske svrhe.
Ovaj Zavod je prerastao u republiki Zavod
za ispitivanje i kontrolu lekova, koji pod ime
nom Zavod za farmaciju Srbije radi od 1960.
godine.
Srbija razvija novu nacionalnu politiku u
oblasti lekova u skladu sa izmenjenim siste
mom proizvodnje i prometa lekova u svetu,
usvaja se Zakon o lekovima i medicinskim
sredstvima (2004.), u skladu sa kojima se
proizvodnja i promet lekova i medicinskih
sredstava usklauje sa direktivama i prepo
rukama EU i ICH i na osnovu koga se 2004.
godine form
ira Agencija za lekove i medicin
ska sredstva Srbije.
Tokom njegove duge istorije, generacije di
plomiranih farmaceut a, lekara, hemiara, i
drugih profesija, specijalista, magistara i dok
tora nauka, kao i stotine zaposlenih, postali
su deo istorije i tradicije Zavoda za farmaciju i
ujedno, Agencije za lekove i medicinska sred
stva Srbije.

Already in the 1948, within the federal administrative body of Yugoslavia, responsible for
health, a Federal Bureau was established,
which in addition to medicines was dealing with
testing and control of sera and vaccines, as well
as cosmetics, dietary supplements, medical
equipment, and other materials that are used in
medical purposes. This Institute has grown into
the Republic Institute for testing and control of
medicines, which under the name of The Pharmacy Institute of Serbia operates from 1960.
Serbia develops a new national policy on medicines in accordance with the amended system
of production and distribution of medicines in
the world, and the Law on Medicinal Products
and Medical Devices (2004) is adopted, pursuant to which the manufacture and distribution
of medicines and medical devices is harmonized with directives and recommendations of
EU and ICH and on the basis of which in 2004
the Medicines and Medical Devices Agency of
Serbia is formed.
During its long history, generations of pharmacists, doctors, chemists, and other professions, specialists, masters and PhDs, as well
as hundreds of employees have become part
of the history and traditions of the Pharmacy Institute and at the same time, Medicines
and Medical Devices Agency of Serbia.

10
Agencija za lekove i medicinska sredstva
Srbije je nadlena da:

The Medicines and Medical Devices Agency

of Serbia is authorized to:

1. Izdaje dozvole za lek, odluuje o izmeni i

dopuni, obnovi i prenosu, kao i prestanku
vaenja dozvole za lek;
2. Vri upis medicinskog sredstva u Registar
medicinskih sredstava, odluuje o izmeni
i dopuni, obnovi upisa, kao i brisanju me
dicinskog sredstva iz Registra medicin
skih sredstava;
3. Vri upis u Registar tradicionalnih biljnih
lekova, odnosno upis u Registar homeo
patskih lekova;
4. Izdaje doz vol e za sprovo en je klin ikog
ispitivan ja leka i med ic ins kog sreds tva,
odlu uje o izmeni i dopuni dozvol e, od
nosno protokol a o sprovoenju klin i
kog isp it ivan ja lekova, don os i odl uke
u vezi s prijavom klin ikog isp it ivan ja,
vri kont rol u sprovoenja klinikog is
pitivanja;
5. Prati neeljene reakcije na lekove (farma
kovigilanca), kao i neeljene reakcije na
medicinska sredstva (vigilanca medicin
skih sredstava);
6. Izdaje uverenja za potrebe izvoza lekova
i medicinskih sredstava u skladu s pre
porukama Svetske zdravstvene organi
zacije;
7. Odobrava uvoz lekova i medicinskih sred
stava za leenje odreenog pacijenta ili
grupe pacijenata, kao i lekova ili medicin
skih sredstava za nauna i medicinska is
traivanja;
8. Vri kategorizaciju lekova, odnosno medi
cinskih sredstava;
9. Odobrava oglaavanje lekova i medicin
skih sredstava;
10. Vri prikupljanje i obradu podataka o pro
metu i potronji lekova i medicinskih sred
stava;
11. Daje informacije i predloge za racionalno
korienje lekova i medicinskih sredstava;
12. Povezuje se sa meunarodnim mrea
ma informacija o lekovima i medicinskim
sredstavima i sa agencijama nadlenim
za lekove i medicinska sredstva i njihovim
asocijacijama;

1. Issue marketing authorizations, decide on

variations, renewals and transfer, as well as
the termination of marketing authorizations;
2. Enter medical devices into the Register of
Medical Devices, decide on the variations,
registration renewals, as well as removal
of medical devices from the Register of
Medical Devices;
3. Perform registration in the Register of Traditional Herbal Medicinal products, or registration in the Register of Homeopathic
Medicinal products;
4. Issue authorizations for clinical trials of
medicinal products and medical devices
conduct, decide on variations of the authorizations, and/or protocols on the conduct of clinical trials, and make decisions
regarding the application of clinical trials,
and control the conduct of clinical trials;
5. Monitor adverse medicinal product reactions (pharmacovigilance), and adverse
reactions to medical devices (vigilance of
medical devices);
6. Issue certificates for the exports of medicinal products and medical devices in accordance with the recommendations of the
World Health Organization;
7. Authorize the imports of medicinal products
and medical devices for a treatment of a
particular patient or a group of patients, as
well as medicinal products or medical devices for scientific and medical research;
8. Perform the classification of medicinal
products or medical devices;
9. Authorize the advertising of medicinal
products and medical devices;
10. Collect and process data on marketing
and consumption of medicinal products
and medical devices;
11. Provide information and suggestions for
rational use of medicinal products and
medical devices;
12. Integrate into the international networks
of information on medicinal products and
medical devices, as well as with the agencies responsible for medicinal products and
medical devices, and their associations;

11
13. Uestvuje u planiranju i sprovoenju si
stematske kontrole lekova i medicinskih
sredstava i uzimanju sluajnih uzoraka iz
prometa;
14. D
 aje miljenja za uvoz i izvoz uzoraka e
lija, odnosno tkiva za postupak klinikog
ispitivanja lekovima;
15. Vri kontrolu kvaliteta lekova i medicinskih
sredstava;
16. Priprema strune publikacije iz nadleno
sti Agencije;
17. V
 ri i druge poslove, u skladu sa zakonom.

13. Participate in planning and implementation of systematic control of medicines

and medical devices, and random sampling from the market;
14. Provide opinions for the imports and exports of cell or tissue samples for clinical
trials procedures of medicinal products;
15. Perform the quality control of medicinal
products and medical devices;
16. Prepare professional publications of the
Agency;
17. Perform the other activities in accordance
with the Law.

ALIMS ktivno uestvuje u razvoju farmace

utske delatnosti u Srbiji, izradi podzakonskih
propisa, daljoj dogradnji nacion
alne politike
u oblasti lekova i medicinskih sredstava i me
unarodnoj saradnji.
Na kraju, vano je istai da je ALIMS i nastav
na baza za studente Farmaceutskih i drugih
fakulteta u Srbiji i da se u ovoj instituciji spro
vode i nauna istraivanja.

ALIMS actively participates in the development of the pharmaceutical sector in Serbia,

making subordinate legislation, further elaboration of the national policy in the area of
medicines and medical devices, and international cooperation.
Finally, it is important to emphasize that ALIMS is also a teaching center for students of
pharmaceutical and other universities in Serbia and that scientific research is conducted
in this institution.

Prostorni resursi
Aktivnosti u ALIMS odvijaju se u dva objekta staroj zgradi, koja je pripadala Zavodu za far
maciju Srbije i novom objektu, ija je izgrad
nja finansirana iz projekta Evropske agencije
za rekonstrukciju. Sve laboratorije u okviru
Nacionalne kontrolne laboratorije ALIMS su
renovirane tako da odgovaraju najstroijim
svetskim zahtevima u oblasti kontrole kvali
teta, to se naroito odnosi na Mikrobioloku
laboratoriju, odnosno sterilni blok ove labo
ratorije.

Facility capacities
Activities in ALIMS are carried out in two
objects the old building, which belonged to
the Pharmacy Institute of Serbia and the new
facility the construction of which was financed
from the project of the European Agency for
Reconstruction. All the laboratories within the
National Control Laboratory of the Agency
have been renovated so as to comply with
the strictest world demands in the domain of
quality control, particularly the Microbiological
Laboratory, i.e. its sterile block.

Oprema
ALIMS raspolae najsavremenijom opre
mom, neophodnom kako za kontrolu kvalite
ta lekova i medicinskih sredstava, tako i za
informatiku podrku svim procesima koji se
u ALIMSU obavljaju. Neophodne kvalifikaci
je i kalibracije opreme, kao i procesi zatite
podataka na raunaru se redovno obavljaju,
prema definisanim planovima.

Equipment
The Agency disposes with the latest equipment necessary for the quality control of
medicines and medical devices, as well as
for the informatics support for all processes
conducted in the Agency. Necessary equipment qualification and calibration, as well as
computer data protection processes are performed on a regular basis, according to the
plans defined.

12
2.4. Ljudski resursi

2.4. Human Resources

Odgovornu, sloenu i raznovrsnu delatnost

Agencije za lekove i medicinska sredstva Sr
bije obavlja kolovano, kvalifikovano, struno i
iskusno osoblje. Agencija se, u svojoj kadrov
skoj politici trudila, da kada je u pitanju staro
sna struktura kadrova, budu zastupljene sve
tri starosne kategorije: mudrost iskusnih stru
njaka, inovativna mladost i snaga zrelosti.

Responsible, complex and diverse activities of

the Agency are performed by trained, qualified,
professional and experienced staff. Agency, in
its personnel policy tried, when it comes to the
age structure of employees, to be representative of all three age categories: the wisdom of
experienced professionals, innovative youth
power and strength of maturity.

Procentualna struktura zaposlenih prema

strunoj spremi

Percentage composition of employees by

education level

Srednja struna sprema

High school degree
25%

Via struna sprema

College degree
4%

Visoka struna sprema

University degree
71%

13
2.5. Meunarodna
saradnja i lanstvo u
meunarodnim
organizacijama

2.5. International
cooperation and
membership
in international
organizations

Meunarodna saradnja Agencije za lekove i

medicinska sredstva Srbije se nadovezuje i
predstavlja ogranak saradnje zdravstvenog
i farmaceutskog sektora u Srbiji sa meuna
rodnim i nacionalnim regulatornim organima i
institucijama koja traje preko 60 godina.
Srbija krajem prethodnog veka zapoinje i
posebno u novom milenijumu ostvaruje in
tenzivnu saradnju na formiranju novog si
stema regulisanja lekova harmonizovanog
sa EU i ICH propisima i preporukama. To je
uraeno uglavnom kroz multilateralnu sa
radnju sa institucijama EU, Svetske zdrav
stvene organizacije (SZO), Evrop
skom agen
cijom za rekonstrukciju (EAR), Evropskom
agencijom za lekove (EMA), Evropskim direk
toratom za kvalitet lekova i brigu o zdravlju
u okviru Saveta Evrop
e (EDQM), Evropskom
mreom laboratorija nadlenih za kontrolu
lekova u okviru EDQM (OMCL Network), sa
organizacijom Rukovodioci agencija za lekove
(HMA), Svetskom organizacijom za zdravlje
ivotinja (OIE) i mnogim drugim, a i putem di
rektne bilatelarne saradnje sa nacion
alnim
autoritetima zemalja EU i sveta, kao i kroz re
gionalnu saradnju sa zemljama jugoistone
Evrope.
U perspektivi pridruivanja EU, izgradnja no
vog regulatornog okvira i osnivanje Agencije
je podrano od strane nekoliko projekata
Evropske unije u period
u od 2002. godine.
Najvei takav projekat je bio Tvining projekat
pod imenom Izgradnja kapaciteta Agencije
za lekove i medicinska sredstva Srbije od fe
bruara 2007. do marta 2009. godine sa Fran
cuskom agencijom za bezbednost zdravstve
nih proizvoda (Agence Franaise de Securit
Sanitare des Produits de Sant - ANSM, ranije
AFSSAPS) i Francuskom Agencijom za veteri

International Cooperation of the Medicines and

Medical Devices Agency of Serbia is built upon
and is a branch of the health and pharmaceutical sectors in Serbia cooperation with international and national regulatory bodies and institutions that has been lasting over 60 years.
Serbia at the end of the last century begins
and especially in the new millennium has established intensive cooperation in the formation of new system of medicines regulation
harmonized with the EU and ICH regulations
and recommendations. This was done mainly through multilateral cooperation with EU
institutions, the World Health Organization
(WHO), the European Agency for Reconstruction (EAR), the European Medicines Agency
(EMA), European Directorate for the Quality of
Medicines and Healthcare within the Council
of Europe (EDQM), the European network of
laboratories in charge of medicines control in
the EDQM (OMCL Network), with organization Heads of Medicines Agencies (HMA), the
World Organization for Animal Health (OIE)
and many others and through direct bilateral
cooperation with national agencies of the EU
countries, as well as through regional cooperation with countries of Southeast Europe.
In the prospect of joining the EU, the construction of a new regulatory framework and the
establishment of the Agency was supported
by several European Union projects in the period since 2002.
Largest such project was the Twinning project entitled Capacity Building of the Medicines and Medical Devices Agency of Serbia
since February 2007 until March 2009 with
the French Agency for Health Products Safety
(Agence Franaise de Securit Sanitare des
Produits de Sant ANSM (former AFSSAPS))

14
narske lekove (Agence Franaise de Securit
Sanitair e des Alments ANSES - ANMV).
U okviru meunarodne saradnje koju Agen
cija trenutno vodi, najpre treba istai aktiv
nosti u okviru IPA projekta (The Instrument
of Preaccession Assistance) koji se realizuje
u periodu od 2009. godine. U pitanju je sa
radnja sa Evropskom agencijom za lekove
(EMA) u okviru pridruivanja Srbije Evrop
skoj uniji.

and the French Agency for veterinary medicines (Agence Franaise de Scurit Sanitaire
des Alments - ANSES - ANMV).
In the framework of international cooperation
that the Agency is currently running, we should
first point out activities under the IPA project
(The Instrument of Pre-Accession Assistance),
which is realized in the period since 2009. It
is cooperation with the European Medicines
Agency (EMA) within Serbias EU accession.

CALIMS
Agence Nationale du Mdicament Vtrinaire (ANMV)

Jo jedan vaan projekat koji je Agencija rea

lizovala u periodu od maja 2011. do juna 2012.
godine je Izgradnja kapaciteta Agencije za
lekove i medicinska sredstva Crne Gore (CA
LIMS). Ovaj projekat je finansiran od strane
Svetske banke, a podrazumevo je unapree
nje kompetentnosti i procesa rada u CALIMS-u
kroz misije naih eksperata u Podgorici i stu

Agencija za lijekove
i medicinska sredstva Crne Gore
Agency for Medicines and
Medical Devices of Montenegro

Another important project implemented by

the Agency during the period from May 2011
until June 2012 is Building the capacity of the
Agency for Medicines and Medical Devices
of Montenegro (CALIMS). This project was
funded by the World Bank, and involves improving the competence and work process in
CALIMS through mission of our experts in the

15

dijske boravke eksperata CALIMS-a u Beo

gradu.
Vano je istai i ugovore o struno-tehni
koj saradnji sa agencijama zemalja u regi
onu (Bosna i Hercegovina, Crna Gora) za
koje Agencija, izmeu ostalog radi kontrolu
kvaliteta odreenih preparata, ali i druge
ugovore, kao one sa obe pomenute Francu
ske agencije (ANSM i NMV), to predsta
vlja nastavak saradnje za ovim institucija
ma posle uspeno okonanog Tvining pro
jekta i najnovije sporazume sa nacionalnim
autoritetima Italije - Agencija za lekove
Italije (Agenzia Italiana del Pharmaco AIFA) i Kanade Ministarstvo zdravlja
Kanade.
Pored ovoga, u okviru intenzivnu saradnje
sa Evropskim direktoratom za kvalitet le
kova i brigu o zdravlju (EDQM) u Strazbu
ru, Francuska, Agencija ima predstavnika
u komisiji Evropske farmakopeje u okviru
EDQM. Ovo podrazumeva uee u razvo

in Podgorica and study visits of CALIMS experts to Belgrade.

It is important to point out the contracts for
professional and technical cooperation with
agencies of the countries in the region (Bosnia
and Herzegovina, Montenegro) for which the
Agency, among other things performs quality
control for certain products, and the other contracts, such as those with both of these agencies of France (ANSM and ANMV), continuing
the cooperation with these institutions after
successfully completing the Twinning project
and the latest agreements with the national
authorities of Italy - Italian Medicines Agency
(Agenzia Italiana del Pharmaco - AIFA) and
Canada - Health Canada.
In addition, as part of an intensive cooperation
with the European Directorate for the Quality of Medicines and Health Care (EDQM) in
Strasbourg, France, ALIMS has a representative in the European Pharmacopoeia Commission within the EDQM. This includes par-

16
ju i reviziji monografija Evropske farmako
peje koje predstavljaju standarde kvaliteta
za supstance koje se koriste u farmaceut
skoj industriji. U okviru drugih tela EDQM
Agencija kroz uee svojih eksperata ta
koe ostvaruje meunarodnu saradnju u
oblastima seruma i vakcina i borb
e protiv
falsifikovanih lekova, kao i evaluaciju CEP-a
i sterilnosti.

Agencija za lekove
i medicinska sredstva Srbije
Medicines and Medical Devices
Agency of Serbia

ticipation in the development and revision of

monographs of the European Pharmacopoeia, which provide standards for the quality of
ingredients that are used in the pharmaceutical industry. In the other bodies of EDQM ALIMS through the participation of its experts
also carries out international cooperation in
the areas of serums and vaccines, and fight
against counterfeit medicines, as well as
evalutation of CEP and sterility.

17
Nacionalna kontrolna laboratorija (NKL) je
lan Evropske mree zvaninih kontrolnih
laboratorija (OMCL mrea) a dugogodinji
izuzetni rezultati studija u kojima NKL
uestvuje u OMCL mrei potvruju kvalitet
rada i strunost zaposlenih u ALIMS.
Najnoviji sporazum koji je Agencija potpisala
u junu 2014. godine je Memorandum o
razumevanju i saradnji izmeu regulatornih
tela Srbije, Hrvatske, Bosne i Hercegovine,
Makedonije i Crne Gore.

National Control Laboratory (NCL) is a member of the European Official Medicines Control Laboratories Network (OMCL Network)
and long-time exceptional results of studies
in which NKL participates in OMCL network
confirm the quality of the work and expertise
of employees in ALIMS.
The latest agreement the Agency has signed
in June 2014 is a Memorandum of understanding and cooperation between regulatory bodies of Serbia, Croatia, Bosnia and Herzegovina, Macedonia and Montenegro.

CALIMS
Agencija za lijekove
i medicinska sredstva Crne Gore
Agency for Medicines and
Medical Devices of Montenegro

18
2.6. Ciljevi razvoja

2.6. Development Goals

Agencija za lekove i medicinska sredstva

Srbije, kao nacionalni kompetentni autoritet
za lekove, osigurae da i u narednom perio
du postupak procene kvaliteta, efikasnosti i
bezbednosti lekova i upis u Registar medi
cinskih sredstava, bude u funkciji ostvarenja
primarnog cilja Agencije osiguravanje da
su pacijentima u Srbiji dostupni svi potrebni
lekovi i medicinska sredstva, u cilju unapre
enja javnog zdravlja, potovanjem najviih
standarda u radu regulatornih autoriteta u
Evropi.
Polazei od ve ostvarenih pozitivnih rezul
tata u regulatornoj performansi, kao i od ak
tivnosti koje su zapoete u prethodnim godi
nama, a u skladu sa vaeim standardima u
profesionalnoj perf ormansi razvijenih agen
cija u zemljama EU, Agencija je definisala
sledee ciljeve:

Medicines and Medical Devices Agency of

Serbia, as the national competent authority
for medicines, will ensure that in future, assessment procedure of quality, effectiveness
and safety of medicines and registration in
the Register of medical devices, meet the
highest standards to the regulatory authorities in Europe so we can achieve the primary
goal of the Agency - to ensure that all necessary medications and medical devices are
available to patients in Serbia, in order to improve public health.
Starting from the positive results achieved in
the regulatory performance, as well as activities that began in previous years, and in accordance with applicable professional standards in the performance of the agencies in
the developed countries in the EU, the Agency
has defined the following objectives:

nastavak ustanovljene pozitivne prakse u

realizaciji regulatornih aktivnosti detaljnim
planiranjem prioriteta;
ostvarivanje kvaliteta i vee efikasnosti u iz
vravanju svih poverenih poslova, a naroi
to u odnosu na postupak izdavanja dozvola
za za lek i upisa medicinskih sredstava u
Registar;
ostvarenje kvaliteta u postupku evaluacije
dokumentacije o lekovima u okviru proce
dure izdavanja dozvola (procena kvaliteta,
pretklinike toksinosti, klinike efikasnosti
i bezbednosti, odnosno terapijske ekviva
lentnosti i postmarketinke bezbednosti
lekova), u skladu sa regulatornim, stru
nim i naunim uputstvima Evropske unije
i drugim prihvaenim standardima u ovoj
oblasti;
kontrola kvaliteta lekova i medicinskih
sredstava u skladu sa standardima evrop
ske i nacionalne farmakopeje i drugim pri
hvaenim standardima u ovoj oblasti;
aktivnosti na akreditaciji Nacionalne
kontrolne laboratorije (NKL) u skladu
sa zahtevima standarda SRPS ISO/IEC
17025:2006;

Continuation of established good practice

in the implementation of regulatory activities by detailed planning of priorities;
Achieving greater quality and efficiency in
the execution of delegated activities, particularly in relation to the issuance of authorizations for the entry of medicine and
medical devices in the Register;
Providing high quality documentation in
the evaluation of medicines in the licensing procedure (assessment of the quality,
preclinical toxicity and clinical safety and
efficacy, therapeutic equivalence and postmarketing medicine safety), in accordance
with regulatory, technical and scientific
guidelines of the European Union and other accepted standards in this area;
Quality control of medicines and medical
devices in accordance with the standards of
the European and national pharmacopoeia and other recognized standards in this
area;
Activities on accreditation of the National
Control Laboratory (NCL) in accordance
to the demands of the SRPS ISO / IEC
17025:2006 standard;

19
primena standarda Dobre klinike prakse,
odobrenje onih klinikih ispitivanja u Srbiji,
koja su u skladu sa principima Dobre kli
nike prakse, kao i jaa kontrola njihovog
sprovoenja;
unapreenje nacionalnog sistema far
makovigilance humanih i veterinarskih
lekova;
razvoj sistema vigilance medicinskih sred
stava i uspostavljanje i razvoj sistema
vigilance vakcina i biljnih lekova;
dalji razvoj sistema redovnog pruanja in
formacija o lekovima i medicinskim sred
stvima strunoj i optoj javnosti;
unapreenje meunarodne saradnje i po
vezivanje sa drugim agencijama i meuna
rodnim asocijacijama;
jaanje kadrovskih kapaciteta Agencije po
veavanjem ukupnog broja zaposlenih, kao
i jaanjem kompetentnosti strunjaka na
ekspertskim poslovima procene dokumen
tacije kontinuiranom edukacijom;
unapreenje prostornih kapaciteta Agenci
je, u smislu obezbeenja osnovnih uslova
rada;
borba protiv falsifikovanih lekova i medicin
skih sredstava;
dalje aktivnosti na polju edukacije javnosti
i zdravstvenih radnika.

Application of standards of Good Clinical

Practice, approval in Serbia of only those clinical trials, which are in accordance with the
principles of Good Clinical Practice, as well as
greater control of their implementation;
Improvement of the national pharmacovigilance system of human and veterinary
medicines;
Development of system of vigilance for
medical devices and establishing and devolping a system of vigilance for vaccines
and herbal medicines;
Further development of the regular provision of information on medicines and medical devices to healthcare professionals and
the general public;
The promotion of international cooperation
and networking with other agencies and
international associations;
Strengthening human resource capacity of
the Agency by increasing the total number
of employees, and strengthening the competence of experts on the expert work of documentation through continuous education;
Improvement in spatial capacities of the
agency, in terms of providing basic working conditions;
Combating counterfeit medicines and medi
cal devices;
Further activities in the field of education of
public and healthcare professionals.

3. Regulatorna
performansa ALIMS
3. ALIMS Regulatory
performance

21
3.1. Predregistracione
aktivnosti

3.1. Pre-registration
activities

Kako bi se stanovnitvu Srbije i zdravstvenim

radnicima pri pruanju zdravstvenih usluga
omoguili to bolji uslovi za prevenciju, dijag
nostiku, leenje i rehabilitaciju, potrebno je
da na tritu Srbije bude zastupljen to iri
asortiman kvalitetnih, bezbednih i efikasnih
lekova i medicinskih sredstava, to je obave
za ALIMS.
U proceni farmaceutske, farmakoloko-tok
sikoloke i klinike dokumentacije o kvalite
tu, bezbednosti i efikasnosti leka uestvu
ju eksperti ALIMS, kao i eksperti saradnici
ALIMS. Procena dokumentacije se obavlja
u skladu sa Zakonom o lekovima i medicin
skim sredstvima, a na osnovu uvida u kom
pletan Opti tehniki document (Common
Technical Dossier CTD) ili Evropski dosi
je, koji klijent dostavlja prilikom podnoe
nja zahteva.
Prva struna procena dokumentacije za lek
se vri u Sektoru za stavljanje u promet hu
manih lekova u okviru formalne procene do
kumentacije. Ova vrsta procene odnosi se na
to da li podnet zahtev za registraciju/obnovu
ispunjava sve uslove u pogledu kompletno
sti i validnosti dokumentacije propisane Za
konom i podzakonskim aktima. Kada doku
mentacija ispuni uslove formalne procene,
svaki njen deo (kvalitet, bezbednost, efika
snost), se dalje detaljno i struno procenjuje
u okviru sutinske procene.
Nakon zavrene sutinska procene, u ovom
sektoru vri se priprema i organizovanje Ko
misije za izdavanje i obnovu dozvole za sta
vljanje humanih lekova u promet. Komisiju
ine eminentni strunjaci iz razliitih oblasti
medicine i farmacije koji na osnovu izvestaja
procene dokumentacije o leku strunih slu
bi ALIMS, i svog znanja i iskustva daju mi
ljenje da li lek treba da dobije dozvolu za
stavljanje u promet.

In order to provide better conditions for the

prevention, diagnosis, treatment and rehabilitation to the population of Serbia and health
care workers in health services, it is necessary
that on the Serbian market a broad a range of
high quality, safe and effective medicines and
medical devices is represented, which is an
obligation of ALIMS.
In assessing the pharmaceutical, pharmacological-toxicological and clinical documentation on quality, safety and efficacy of medicine
ALIMS experts, and ALIMS associate experts
are involved. Assessment of documentation
is done in accordance with the Law on Medicines and Medical Devices, and based on the
entire General Technical Document (Common
Technical Dossier - CTD) or the European record, which is submitted by the client when
applying.
First expert assessment of the documentation for medicine is made in Licencing Department for Human Medicines as part of the
formal evaluation of the documentation. This
type of assessment relates to whether the
request for registration / renewal meets all
requirements in terms of completeness and
validity of documents provided by the Law
and bylaws. When the documentation meets
requirements of formal assessments, each
part of it (quality, safety, efficiency), is given a
detailed and professional estimate within the
essential assessment.
After finishing the essential assessment, the
preparation and organization of the Commission for Marketing Authorization and MA renewal of the human medicines is performed
in Licencing Department. Committee is constituted of eminent experts from various fields
of medicine and pharmacy, which on the basis of the assessment report on the medicinal product documentation expert services of
our Agency, and their knowledge and experience give an opinion whether the medicines
should be licensed for marketing.

22

Ukoliko je lek odobren za izdavanje dozvo

le, u Sektoru za stavljanje u promet humanih
lekova se vri formiranje, kontrola i odobra
vanje finalnih izlaznih dokumenta Agencije:
Reenja za stavljanje leka u promet i njego
vih sastavnih delova - Saetka karakteristika
leka (SmPC), Uputstva za lek (PIL) i teksta za
spoljnje i unutranje pakovanje leka.
Saetak karakteristika leka je namenjen
zdravstvenim strunjacima (lekarima i farma
ceutima) i prua sve informacije neophodne
za pravilno propisivanje i upotrebu leka. On
predstavlja kratak dosije leka, a informacije
iznete u njemu su utemeljene u proceni doku
mentacije leka i harmonizaciji informacija sa
onim aktuelnim, odobrenim u Evropskoj uniji.
Uputstvo za lek namenjeno je pacijentu i
omoguava mu da razume sve aspekte tera
pije odgovarajuim lekom. Uputstvo mora bi
ti u skladu sa saetkom karakteristika leka,
napisano na nain razumljiv pacijentu, jasno
i kratkim reenicama. Nalazi se u pakovanju

If the medicine is approved for the marketing

authorization, in Licencing Department the
formation, control and approval of the Agencys final output document is made: Marketing Authorization and its components - Summary of product characteristics (SmPC), Patient information leaflet (PIL) and the text for
the outer and inner packaging of medicine.
Summary of product characteristics is intended
for health professionals (doctors and pharmacists) and provides all the information necessary for the proper prescribing and use of medicines. It represents a brief dossier of medicine,
and information presented herein is based in
the assessment of medicine documents and
information harmonization with those currently
approved in the European Union.
Patient information leaflet is intended for the
patient and allows him to understand all aspects of therapy with appropriate medicine.
The leaflet must be consistent with the summary of product characteristics, written in a

23
leka. Primarna uloga teksta pakovanja je ja
sna i nedvosmislena identifikacija leka i uslo
va za njegovu bezbednu primenu.
Kroz definisanje i unos matinih podataka o
leku u centralnu bazu podataka Agencije se
u informacionom sistemu Agencije moe pra
titi ivotni ciklus leka, odnosno sve promene
u okviru njegovog kvaliteta, bezbednosti i efi
kasnosti. Takoe, to omoguava da podaci na
izlaznim dokumentima Agencije budu preci
zni i tani, kao i da se poveu slini lekovi i na
taj nain identifikuju terapijske paralele.
Agencija na osnovu procenjene dokumenta
cije odobrava uvoz neregistrovanih lekova
i medicinskih sredstava neophodnih za hit
nu, specifinu terapiju pojedinih pacijenata
ili grupe pacijenata, na zahtev zdravstvenih
ustanova. Takoe se odobrava uvoz lekova i
medicinskih sredstava namenjenih za klini
ka i nauna istraivanja kao i u svrhu dobija
nja dozvole za stavljanje u promet.
Procena bezbednosti leka podrazumeva eva
luaciju dokumentacije o bezbednosti leka u
postupku dobijanja dozvole za njegovo sta
vljanje u promet, njenih obnova, izmena i do
puna (varijacije) i izradu ekspertskog izveta
ja o bezbednosti leka, kao i procena period
i
nog izvetaja o bezbednosti leka (PSUR) do

manner understandable to the patients, with

clear and short sentences. It is located in the
package of the medicine. The primary role of
the text package is clear and unambiguous
identification of the medicine and the conditions for its safe use.
Through defining and entering the master
data on the medicine into the central database of the Agency in the Agencys information system the life cycle of a medicine can be
tracked, or any changes in its quality, safety
and efficacy. Also, it allows that output data
to the Agencys documents are accurate and
precise, as well as links similar medicines,
and thus identifying the therapeutic parallels.
Agency, based on the estimated documentation allows the importation of unregistered
medicines and medical devices necessary for
the immediate, specific treatment of individual
patients or groups of patients, at the request of
health care institutions. Also, the importation
of medicines and medical devices intended for
clinical and scientific research as well as in the
purpose of obtaining a marketing authorization
is allowed.
Assessment of medicine safety includes evaluation of documentation on product safety in
the process of obtaining a license for its mar-

24
stavljenih od strane farmaceutske industrije
nakon dobijanja dozvole za stavljanje leka u
promet.
to se tie procene efikasnosti leka, vri se
procena dokumentacije o efikasnosti leka u
postupku dobijanja dozvole za njegovo sta
vljanje u promet, njenih obnova, izmena i
dopuna (varijacije) i izradu ekspertskog iz
vetaja o efikasnosti leka, a zatim procena
dokumentacije o bioe kvivalenciji u postupku
dobijanja dozvole za njegovo stavljanje u pro
met i izradu ekspertskog izvetaja o bioekvi
valenciji.
U okviru Administrativnog sektora koji u svom
sastavu ima Slubu za prijem zahteva iz nad
lenosti Agencije i poslove pisarnice i Ode
ljenje za pravne i opte poslove pored optih
pravnih poslova, obavljaju se i regulatorni po
slovi. Naim
e, izvrioc i na ovim radnim mesti
ma izdaju pravna miljenja u oblasti lekova i
medicinskih sredstava, kao i pravna miljenja
u postupku formalne procene dokumentacije
o leku.
Pored Zakona o lekovima i medicinskim sred
stvima, u okviru regulatornih poslova u Agen
ciji se primenjuje i Zakon o optem upravnom
postupku u odnosu na sve poverene poslove.
Agencija odobrava izdavanje kontrolnih ma
rkica, kao i tampanje dodatnih markica za
lekove na stranom pakovanju, kao dodatnu
identifikaciju i zatitu od falsifikovanja.
Agencija postupa i po zahtevima za slobodan
pristup informacijama od javnog znaaja ko
jima raspolae ovaj organ javne vlasti, a koje
su nastale u radu ili u vezi sa njenim radom.
Primenjujui navedene propise, pored brige o
lekovima i medicinskim sredstvima, Agencija
se stara da se ostvari slobodni demokratski
poredak i informie javnost o svom radu.

0123456789

keting, its renewal, amendment (variation)

and the preparation of expert reports about
medicine safety, as well as the assessment
of periodic safety update reports (PSURs)
submitted by the pharmaceutical industry after obtaining a marketing authorization.
As for the assessment of medicine efficacy,
the documentation of efficacy is evaluated in
the process of obtaining a license for its marketing, its renewal, amendment (variation) and
the preparation of expert reports of medicine
efficacy, and then assessment of bioequivalence documentation in the process of obtaining license for its marketing and development
of an expert report on bioequivalence.
In the Administrative Department, which is
composed of the Office for receipt of applications under the Agencys competence and
clerks office (administrative office) and General and Legal Affairs Department where in
addition to general legal activities, regulatory
affairs are conducted. The employees in these
positions are issuing legal opinions in the area
of medicines and medical devices, as well as
legal opinions in the process of formal evaluation of the documentation on the medicine.
In addition to the Law on Medicines and
Medical Devices Regulatory Affairs within the
Agency the Law on Administrative Procedure
in respect of all assigned duties is applied.
Agency approves issue of control stamps, and
printing of additional stamps for medicines
on the packaging, as an additional identification and protection against counterfeiting.
Agency acts on requests for access to information of public importance held by this public authority, which occurred in the workplace
or in relation to its work.
Applying these rules, in addition to dealing
with medicines the Agency is responsible for
ensuring that a free democratic order is established and informs the public about its work.

25
3.2. Medicinska sredstva

3.2. Medical devices

Sektor za medicinska sredstva obavlja slede

e Zakonom poverene poslove iz oblasti me
dicinskih sredstava:
upis medicinskog sredstava u Registar me
dicinskih sredstava;
obnovu, izmenu i dopunu upisa medicinskog
sredstava u Registar medicinskih sredstava,
kao uslov za putanje u promet na trite Srbije;
izdavanje strunih miljenja o kategoriza
ciji i klasifikaciji medicinskih sredstava;
uestvuje u izdavanju odobrenja za uvoz
neregistrovanih medicinskih sredstava, na
zahtev zdravstvenih ustanova, a za ivotno
ugroene pacijente;
uestvuje u izdavanju odobrenja za upo
trebu promotivnog materijala i druge doku
mentacije koja se odnosi na oglaavanje
medicinskog sredstva;
vri praenje neeljenih reakcija na me
dicinska sredstva (vigilanca medicinskih
sredstava);
uestvuje u pripremi podzakonskih akata
iz oblasti proizvodnje i prometa medicin
skih sredstava i dr.

Medical Devices Department performs the

following entrusted tasks in the field of
medical devices:
Entry of medical device in the Register of
medical devices;
Renewal, amendment of, and addition to
registration of medical devices in the Register of medical as a condition for release
on the market of Serbia;
Issuing expert opinions on the categorization and classification of medical devices;
Participate in the issuance of permits to
import unregistered medical devices, at
the request of health institutions and the
patients whose life is in danger;
Participates in granting approval for the
use of promotional materials and other
documentation relating to the advertising
of medical devices;
Monitoring of adverse reactions to medical
devices (medical devices vigilance)
Participation in the preparation of laws pertaining to the production and sale of medical devices, etc.

Za medicinska sredstva koja poseduju CE znak,

a to podrazumeva da je kontrola tog medicin
skog sredstva izvrena u nekom od akreditova
nih evropskih notifikacionih tela i da je to medi
cinsko sredstvo usaglaeno sa EU direktivama
o medicinskim sredstvima, upis u Registar me
dicinskih sredstava je administrativna proce
dura. Meutim, za medicinska sredstva koja
ne poseduju CE znak, procedura upisa u Regi
star medicinskih sredstava je znaajno dua i
komlikovanija, jer se vri na osnovu dozvole za
stavljanje u promet, a na bazi uraene procene
kvaliteta, bezbednosti i efikasnosti, prema me
unarodno prihvaenim standardima.
Jedan od vanih zadataka Sektora za medicin
ska sredstva u narednom periodu je usposta
vljanje sistema vigilance medicinskih sred
stava u naoj zemlji, a sve u cilju obezbeenja
bolje zatite i unapreenja ivota i zdravlja
ljudi. Vigilanca medicinskih sredstava je skup
aktivnosti koje se odnose na prikupljanje, pro

For medical devices which have the CE mark,

which means that the control of the medical
devices was made in any of the accredited
European notification bodies and that it is a
medical device that complies with EU directives on medical devices, registration of medical devices is an administrative procedure.
However, for medical devices that do not have
the CE mark, the procedure for registration of
medical devices is significantly longer and
more complicated, because it is done on the
basis of a marketing authorization, and on
the basis of the evaluation of quality, safety
and efficacy, according to internationally accepted standards.
One of the important tasks for the Medical devices Department in the coming period is to
establish a system of vigilance of medical devices in the country, with the aim of providing
better protection and improvement of human
life and health. Vigilance of medical devices is

26
a set of activities related to the collection, assessment, understanding and responding to
new information about the risks arising from
the use or application of medical devices, and
in particular its harmful effects, interactions
with other substances or products, contraindications, abuse, reduced activity, failure and
technically invalidity. The Agency organizes
and monitors the vigilance of medical devices,
collects information on the quality, safety and
efficacy of medical devices after they are placed
on the market, as well as the rate of discovery
of known and new adverse reactions.
On all matters within the jurisdiction of the
Medical Devices Department, the cooperation
with manufacturers of medical devices or their
authorized representatives (representative offices, agents, distributors, etc.) is achieved.
Significant acceleration and simplification
of procedures for resolving clients requests
within the jurisdiction of the Medical Devices
Department, is of great importance and beneficial for both the customers and for patients
and other users of medical devices, which will
promptly and adequately have available high
quality, safe and effective medical devices in
the Serbian market.

Rezultati vigilance medicinskih sredstava

Medical Devices Vigilance results

Broj prijava / Number of reports

cenu, razumevanje i reagovanje na nova sa

znanja o rizicima koji proizilaze iz upotrebe ili
primene medicinskog sredstva, a posebno nje
govog tetnog delovanja, interakcije s drugim
supstancama ili proizvodima, kontraindikaci
je, zloupotrebe, smanjenog delovanja, kvara
i tehnike neispravnosti. Agencija organizuje
i prati vigilancu medicinskih sredstava, priku
pljanjem informacija o kvalitetu, bezbednosti i
efikasnosti medicinskih sredstava posle njiho
vog putanja u promet, kao i uestalost pozna
tih i otkrivanje novih neeljenih reakcija.
Na svim poslovima iz nadlenosti Sektora za
medicinska sredstva, ostvaruje se saradnja
sa proizvoaima medicinskih sredstava, od
nosno njihovim ovlaenim predstavnicima
(predstavnitvima, zastupnicima, distribute
rima i dr.).
Znaajno ubrzanje i pojednostavljena proce
dura reavanja zahteva klijenata iz nadle
nosti Sektora za medicinska sredstva, je od
velikog znaaja i koristi kako za same klijen
te, tako i za pacijente i druge korisnike medi
cinskih sredstava, koji e blagovremeno i na
adekvatan nain imati dostupna kvalitetna,
bezbedna i efikasna medicinska sredstva na
tritu Srbije.

644

700
600
500

338

400
300
200
100

69

0
2011

2012

2013

27
3.3. Veterinarski lekovi

3.3. Veterinary medicines

U okviru Agencije postoji Veterinarski sektor

koji je nadlean za stavljanje u promet vete
rinarskih lekova, obnove i varijacije, zatim za
klinika ispitivanja, farmakovigilancu veteri
narskih lekova i davanje strunih miljenja
dok se laboratorijska kontrola kvaliteta vete
rinarskih lekova obavlja u Nacionalnoj kon
trolnoj laboratoriji Agencije.
Propisana struktura registracionog dosijea za
veterinarske lekove je podeljena na dve sek
cije prema vrsti lekova: farm
aceutski i imu
noloki lekovi.
Registracioni dosije za obe sekcije sastoji se
od administrativnih podataka i neophodnih
podataka kojima se dokazuje kvalitet, bez
bednost i efikasnost veterinarskih lekova.
Meutim, zbog izrazito sloene materije kojom
se dokazuju kvalitet, bezbednost i efikasnost
veterinarskih lekova, kao i veoma raznovrsnog
dijapazona proizvoda postoji potreba da se
dodatnim podzakonskim aktima specifino re
guliu pojedini segmenti u ovoj oblasti.
Agencija naroitu panja posveuje veteri
narskim lekovima koji posredno mogu uticati
na hranu, te se u velikom obimu bezbednost
veterinarskih lekova odnosi takoe i na bez
bednost ljudi.
U saradnji sa Ministarstvom poljoprivrede i
zatite ivotne sredine Republike Srbije, odno
sno Upravom za veterinu uinili smo i znaajne
pomake na podruju provere kvaliteta lekova iz
prometa koja je rezultirala odgovarajuim regu
latornim akcijama.
Nadalje, Agencija e doprineti sigurnosti i
votinja intenzivnim praenjem i informisa
njem o neeljenim efektima lekova razvija
njem sistema farmakovigilance, kao to je to
ve uinila za lekove za humanu upotrebu.

Within the Agency exists a Veterinary Medicines Department is organized which is responsible for the marketing of veterinary medicines,
renewal and variation, then also for clinical trials, pharmacovigilance of veterinary medicines
and expert opinions while laboratory quality
control of veterinary medicines is performed in
the National Control Laboratory of the Agency.
The prescribed structure of registration dossiers
for veterinary medicine is divided into two sections according to the type of medicines: pharmaceutical and immunological medicines.
The registration dossier for each section
consists of administrative records and data
necessary to prove the quality, safety and efficacy of veterinary medicines.
However, due to the extremely complex subject, with which the quality, safety and efficacy of veterinary medicines is proved, as well
as with a diverse range of products there is
a need for additional laws in order to specifically regulate certain segments in this area.
Agency is paying special attention to veterinary
medicines that may indirectly affect the food,
and to a large extent the safety of veterinary
medicines also relates to security of people.
In cooperation with the Ministry of Agriculture and Enviromental Protection of the Republik of Serbia, that is, the Veterinary Directorate we have made significant progress in
the area of checking the quality of medicines
on the market that has resulted in appropriate regulatory actions.
In addition, the Agency will contribute to the
safety of animals through intensive monitoring and providing information on the adverse
medicines reactions by developing pharmacovigilance system, as is already done for
medicines for human use.

28
3.4. Postregistracion
e
aktivnosti

3.4. Post-registration
activities

Farmakovigilanca

Pharmacovigilance

Agencija za lekove i medicinska sredstva

Srbije, primenom standarda dobre prakse u
farmakovigilanci vri poslove organizovanog
i kontinuiranog praenja neeljenih dejstava
lekova:
kroz sponatno prijavljivanje neeljenih reak
cija na lekove,
prikupljanjem i procenom prijava zdrav
stvenih radnika o neeljenim reakcijama u
toku leenja bolesnika,
prijavljivanjem neeljenih reakcija u toku
klinikih ispitivanja i
procenom periodinih izvetaja o nee
ljenim reakcijama na lekove u postmar
ketinkom periodu dostavljenih u skla
du sa propisima od strane odgovornih
lica za farmakovigilancu proizvoaa
lekova (Periodic Safety Update Reports PSURs).

Medicines and Medical Devices Agency of

Serbia, through the implementation of standards of good practice in pharmacovigilance
activities organizes and carries out continuous monitoring of adverse drug reactions:
Through the spontaneously reporting of
adverse reactions to medicines,
Through collecting and evaluating health
care professionals reports on adverse
effects during treatment of patients,
Through reporting of adverse reactions
during clinical trials and,
Through evaluation of periodic reports on
adverse reactions to medicines in the postmarketing period provided in accordance
with the regulations by responsible person
for pharmacovigilance of medicine manufacturers (Periodic Safety Update Reports
- PSURs).

U Agenciji se u potpunosti sprovodi volumen

9 propisa EU, koji se odnosi na farmakovigi
lancu lekova u humanoj, a takoe i na farma
kovigilancu lekova u veterinarskoj medicini,
kao i smernice Meunarodne konferencije o
harmonizaciji (ICH).
Nacionalni centar za farmakovigilancu (NCF)
je takoe u kontinuiranoj saradnji i vezi po
sredstvom vigibaze sa kolaborativnim cen
trom Svetske zdravstvene organizacije za
praenje neeljenih reakcija lekova u Upsa
li, vedska (The Uppsala Monitoring Centre
- UMC). Strunjaci NCF-a redovno prisustvu
ju i doprinose informativnim i edukativnim
skupovima u ovoj oblasti, kao i na godinjim
sastancima zemalja lanica Meunarodnog
centra u Upsali i drugih.
Procena bezbednosnih profila lekova je va
ljan preduslov za sprovoenje racionalne
(efikasne, bezbedne i ekonomine) farmako
terapije.

The EU regulation volume 9 is fully implemented within the Agency, which relates to pharmacovigilance of medicines for human and also on
Pharmacovigilance for veterinary medicines, as
well as the guidelines of the International Conference on Harmonization (ICH).
National Pharmacovigilance Centre (NPC) also
has continuous collaboration and connection
through vigibase with the World Health Organization Collaborating Center for International Drug Monitoring in Uppsala, Sweden (The
Uppsala Monitoring Centre - UMC). Experts
of the NPC regularly attend and contribute to
informational and educational events in the
area, as well as the annual meetings of the
member countries of the International Centre
in Uppsala and others.
Assessment of medicine safety profile is a
valid precondition for the implementation of
a rational (efficient, safe and cost-effective)
pharmacotherapy.

29
Implementacija principa savremene klinike
farm
akologije, klinike farmacije, farmakoki
netike, farm
akoterapije i farmakoepidemiolo
gije predstavlja imperativ za postizanje raci
onalne primene lekova.
NCF, evidencijom i procenom svih prijavlje
nih neeljenih reakcija na lekove, procenom
uzrono-posledine povezanosti izmeu pri
mene leka/medicinskog sredstva i neelje
nih reakcija, identifikacijom potencijalnih sig
nala, utvrivanjem faktora rizika, procenom
incidencije, kao i izradom drugih znaajnih
periodinih analiza prijavljenih neeljenih re
akcija, doprinosi da primenjena farmakotera
pija obezbedi postizanje eljenog terapijskog
efekta uz minimalan rizik od neeljenih reak
cija lekova.

Implementation of principles of modern clinical pharmacology, clinical pharmacy, pharmacokinetics, pharmacotherapy and pharmacoepidemiology is imperative to achieve
the rational use of medicines.
NPC, through recording and evaluating all
reported adverse reactions to medicines, by
assessment of the relationships between
the use of medicines / medical devices and
adverse reactions, identification of potential signals, identifying risk factors, estimate
the incidence, as well as making other significant periodic analysis of reported adverse
reactions, contributes that applied medicine
therapy ensures the achievement of the desired therapeutic benefit with minimal risk of
adverse drug reactions.

Rezultati spontanog prijavljivanja Nacional

nom centru za farm
akovigilancu Agencije:

Results of spontaneous reporting to the

Agencys National Pharmacovigilance Centre.

Godina / Year

2005.

2006.

2007.

2008.

2009.

2010.

2011.

2012.

2013.

Broj prijava /
Numbers of
reports

102

206

337

423

572

781

962

1179

1173

Informacije o lekovima,
praenje potronje
i prometa i lani lekovi

Information about
medicines, monitoring of
consumption and marketing
and counterfeit medicines

Naini informisanja strune i opte javno

sti o lekovima i medicinskim sredstvima se
sprovode kroz aktivnosti Nacionalnog cen
tra za informacije o lekovima i medicinskim
sredstvima, kao i kroz savremenu web pre
zentaciju o aktivnostima Agencije na adresi
www.alims.gov.rs.
Dobra informaciona praksa i u okviru nje se
lekcija pouzdanih informacija o lekovima i
medicinskim sredstvima u danas prisutnoj
hiperinflaciji lekova je Conditio sine qua non
za adekvatnu i bezbednu upotrebu lekova u
prevenciji, dijagnostici, terapiji i rehabilitaciji
u humanoj i veterinarskoj medicini.

Ways of informing professional and general

public on medicinal products and medical
devices are implemented through the activities of the National Center for Information on
Medicines and Medical Devices, as well as
through modern web presentation on the activities of the Agency at the address www.alims.gov.rs.
Good information practices and within it the selection of reliable information about medicines
and medical devices in today-present hyperinflation of medicines is a Conditio sine qua non
for the proper and safe use of medicines in the

30
Strunjaci Agencije na osnovu pristupa savre
menim bazama podataka pruaju pouzdane i
bezbedne informacije o lekovima i medicin
skim sredstvima, kao i savete pacijentima i
zdravstvenim strunjacima za njihovu upotre
bu na racionalan i ekonomian nain.
U cilju promocije bezbedne upotrebe lekova i
medicinskih sredstava prikupljaju se i proce
njuju informacije za bazu podataka u okviru
integralnog informacion
og sistema, i pripre
maju publikacije (registar, farmakoterapijski
vodi i dr.).
U cilju farmakoepidemiolokih i farmakoeko
nomskih istraivanja Agencija prati promet i
potronju lekova i medicinskih sredstava.
Agencija redovno daje informacije o potro
nji lekova, izdatim dozvolama za klinika
ispitivanja, dozvolama za stavljanje u pro
met, obnovama i varijacijama dozvola za
stavljanje u promet, kao i povlaenju iz pro
meta lekova i medicinskih sredstava, o ne
eljenim dejstvima lekova, racionalnoj upo
trebi lekova i druge.
Novi globalni nain trgovanja i uslovi slobod
ne trgovine doveli su do ukupnog poveanja
proizvodnje svih lekova na svetskom tritu,
to je stvorilo povoljnije uslove i za proizvod
nju substandardnih i lanih lekova (counter
feit drugs).
Substandardni lek je originalni proizvod koji
ne odgovara postavljenoj specifikaciji kvalite
ta, to ima za posledicu neefikasnost leka i
dovodi u opasnost pacijenta. Substandardni
lek moe da bude posledica nemarnosti, ljud
ske greke, nedovoljnih ljudskih i finansijskih
sredstava ili falsifikovanja.
Lani lekovi predstavljaju deo ireg fenomena
substandardnih lekova. Nastali su kao posle
dica namernog i lanog oznaavanja obeleja
njegovog identiteta i/ili porekla.
Falsifik ovanje lekova oznaava namerno po
greno obeleavanje gotovih lekova ili sasto
jaka koji se koriste u njihovoj proizvodnji u smi
slu njihovog identiteta, sastava i/ili porekla.
Mogu se falsifikovati i zatieni i generiki pro
izvodi, a falsifikat moe da bude proizvod sa:
ispravnim sastojcima;
pogrenim sastojcima;

prevention, diagnosis, treatment and rehabilitation in human and veterinary medicine.

Agency experts on the basis of access to
modern databases provide reliable and secure information about medicines and medical devices, and guidance to patients and
health care professionals for their use in a
rational and cost-effective manner.
In order to promote the safe use of medicines
and medical devices the information for the
database within the integrated information
system are collected and evaluated, and
publications are prepared (register, and pharmacotherapeutic guide and others).
In order to perform pharmacoepidemiological
and pharmacoeconomic research the Agency
monitors marketing and consumption of
medicines and medical devices.
The Agency regularly provides information on
the consumption of medicines, issued permits
for clinical trials, marketing authorization, renewal and variation of licenses for marketing
authorization, and withdrawal from the market of medicines and medical devices, about
the side effects of medicines, rational use of
medicines, and others.
The new ways of global trading and conditions of free trade have led to an overall increase in production all medicines on the
world market, which created favorable conditions for the production of substandard and
fake medicines (counterfeit drugs).
Substandard medicine is an original product
which does not meet the set of quality specifications, resulting in inefficiency of medicine and
endangering the patient. Substandard medicine
may be result of negligence, human error, insufficient human and financial resources or counterfeiting.
Fake medicines are part of a broader phenomenon of substandard medicines. They occur as
a result of the deliberate and fraudulent mark of
its identity and/or source.
Counterfeiting of medicines means deliberately wrong labeling of finished medicines or
ingredients used in their manufacture in terms
of their identity, composition and/or origin.

31
bez aktivnih supstanci;
sa aktivnim supstancama u nedovoljnim
koliinama ili proizvod upakovan u lano
pakovanje.
S tim u vezi zdravstveni radnici u svim obla
stima prakse treba da:
potuju principe Dobre apotekarske prak
se, Dobre proizvoake prakse (GMP),
Dobre distributivne prakse (GDP), itd.;
kupuju lekove samo iz pouzdanih izvora,
obraajui pri tom panju na njihove uslove
uvanja pre kupovine, kao i u lancu snabde
vanja;
alarmiraju razlike u kvalitetu pakovanja,
obeleavanja ili uputstva za upotrebu, kao
i u fizikom izgledu lekova;
dravnim merodavnim telima prijave svaki
sluaj sumnje, bilo da je u pitanju odsustvo
oekivanog terapijskog efekta ili da je lani
lek ponuen ili dostavljen i izoluju i ne iz
daju svaki lek za koji se sumnja da je laan
i da sarauju sa istraiteljima kako bi se
pronaao izvor snabdevanja.
Zatita stanovnitva od upotrebe substan
dardnih i lekova loeg kvaliteta, kao i lanih
lekova, a u skladu sa preporukama Svetske
zdravstvene organizacije, jedan od ciljeva
ALIMS i u tom pogledu ostvarujemo blisku
saradnju sa nadlenim institucijama u Srbiji
ali i na meunarodnom planu.

Oglaavanje lekova
i medicinskih sredstava
Oglaavanje lekova i medicinskih sredstava
je svaki oblik davanja istinitih informacija o
ovim proizvodima optoj i strunoj javnosti

Protected and generic products can be counterfeited and counterfeit products may have:
Right ingredients;
Wrong ingredients;
No active ingredients;
Active ingredients in insufficient quantities or product packed in fake packaging.
In relation to this, health care professionals in
all areas of practice should:
Respect principles of Good Pharmacy
Practice, Good Manufacturing Practice
(GMP), Good Distribution Practice (GDP),
etc.;
Buy medicines from trusted sources only,
paying at the same attention to their storage conditions before buying, as well as in
the supply chain;
Alarming about the differences in quality
packaging, labeling or Patient information
leaflet, as well as the physical appearance
of medicines;
Report any case of doubt to authoritative
state bodies, whether it is an absence of
expected therapeutic effect or that a false
medicine is offered or delivered and isolate
and not issue every medicine that is suspected to be false, and to cooperate with
investigators to find the source of supply.
Protection of the population from the use of
substandard and poor quality medicines and
fake medicines, according to the recommendations of the World Health Organization,
is one of ALIMS goals and in this regard we
have close cooperation with other institutions
in charge of this in Serbia, but also on international level.

Advertising of medicines
and medical devices
Medicines and medical devices advertising is
every form of providing general and professional public with the accurate information
about these products in order to encourage

32
radi podsticanja propisivanja i prometa leko
va i medicinskih sredstava, njihovog snabde
vanja, prodaje i potronje. Od 2010. godine,
Agencija je dobila nadlenost u odobravanju
oglaavanja lekova i medicinskih sredstava.
Agencija daje odobrenja za:
1) r eklamiranje medicinskih proizvoda putem
sredstava javnog informisanja, ukljuujui
i internet, reklamiranje na javnim mestima
i druge oblike reklamiranja leka (potom,
posetama i sl.);
2) promociju medicinskih proizvoda zdrav
stvenim i veterinarskim radnicima koji
propisuju lekove, i to obavetavanjem na
strunim skupovima, u strunim asopisi
ma i drugim oblicima promocije.
Agencija odobrava materijal koji je namenjen
kako strunoj javnosti (zdravstveni i veteri
narski radnici koji propisuju lekove, diplomi
rani farmaceuti i druga struna lica u oblasti
proizvodnje i prometa lekova na veliko i malo,
kao i u organizaciji obaveznog zdravstvenog
osiguranja) tako i optoj javnosti (graani
Republike Srbije).

the prescribing and marketing of medicines

and medicinal devices, their supply, sale and
consumption. Since 2010, The Agency has a
jurisdiction in the approval of advertising of
medicines and medical devices.
The Agency issues authorizations for:
1. Medicinal product advertising through the
media, including the Internet, advertising in
public areas and other forms of advertising
(mail, visits, etc.);
2. Promotion of medicinal products to health
care and veterinary professionals who prescribe medicinal products, at professional
conferences, in professional journals and
other forms of promotion;
Agency approves material intended for professional public (health care and veterinary
professionals who prescribe medicines, pharmacists and other professionals in the field
of production and distribution of medicines
to wholesalers and retailers, as well as the
organization of mandatory health care insurance) as well as the general public (citizens
of the Republic of Serbia ).

Prema zakonu, zabranjeno je oglaavanje

leka:
- koji nema dozvolu za lek, odnosno ija je do
zvola za lek prestala da vai;
- koje dovodi u zabludu, odnosno navodi na
zakljuak da su bezbednost i efikasnost le
ka osigurani njegovim prirodnim poreklom;
- kojim se opisuje bolest i uspesi leenja tako
da navode na samoleenje;
-n
 a neodgovarajui i senzacion
alistiki nain
o njegovim uspesima u leenju, prikaziva
njem slika i dr.;
- kojim se navodi na zakljuak da lek spada
u hranu, kozmetiku ili druge predmete opte
upotrebe;
- radi podsticanja na propisivanje i izdavanje
lekova davanjem ili obeavanjem finansij
skih, materijalnih ili drugih koristi.

According to the Law, it is forbidden to advertise medicinal products:

- That do not have a marketing authorization,
or whose marketing authorization has expired;
- In a misleading way, and suggest that the
safety and efficacy of a medicinal product
are secured by its natural origin;
- Through describing the disease and success of a treatment as to suggest an individual treatment;
- Presenting the success of a medicinal product treatment in an inadequate and spectacular way, by displaying pictures, etc.;
- In a way that suggests that a medicinal
product can be classified as food, cosmetics, or other items that have general use;
- In order to encourage prescribing and issuing of a medicinal product by giving or promising financial, material or other benefits.

33
Takoe, zabranjeno je reklamiranja leka op
toj javnosti:
- koji se izdaju uz recept;
- k oji se izdaju na teret sredstava zdravstve
nog osiguranja;
- koji sadre opojne droge ili psihotropne
supstance, lekova za tuberkulozu, infektiv
ne bolesti...
Promotivni materijal namenjen strunoj jav
nosti mora da sadri osnovne podatke o le
ku iz dozvole za lek, odnosno podatke koji su
usklaeni sa Saetkom karakteristika leka,
kao i podatke koji se odnose na reim izda
vanja leka. Ovi podaci moraju biti tani, au
rirani, proverljivi i u dovoljnoj meri potpuni da
primalac na osnovu njih moe da form
ira svo
je miljenje o terapijskoj vrednosti odreenog
leka, kao i da imaju datum kada su sainjeni
ili kada su poslednji put revidirani.
Lekovi koji se izdaju bez recepta se mogu re
klamirati u sredstvima javnog informisanja
itd., ali mogu se davati informacije o njihovom
delovanju samo u skladu sa Saetkom karak
teristika leka koji je sastavni deo dozvole za
lek. Reklamiranje lekova koji se izdaju bez re
cepta mora biti objektivno i ne sme dovoditi u
zabludu a Agencija utvruje listu lekova koji
se mogu reklamirati na ovaj nain.

Also, it is forbidden to advertise to the general public:

- Medicinal products that are issued with a
prescription;
- Medicinal products that are issued at the
expense of health care insurance;
- Medicinal products containing opiates or psychotropic substances, medicinal products for
tuberculosis, for infectious diseases...
Promotional materials designed for the professional public must contain basic information on
the medicine from marketing authorization, that
is, the data which is consistent with the Summary of Product Characteristics, as well as information relating to the regimen of medicines
issuance. These data must be accurate, up to
date, verifiable and sufficiently complete to the
recipient to provide the possibility of forming an
opinion on the therapeutic value of a medicine,
and well as to have the date when they were
made or when they were last revised.
Medicines obtained without a prescription can
be advertised in the media and so on, but the
information about their activities can be provided only in accordance with the Summary of
Product Characteristics, which is integral part
of the marketing authorization. Advertising of
medicines obtained without a prescription has
to be objective and not misleading and the
Agency prepares a list of medicines that can be
advertised in this way.

34
3.5. Klinika ispitivanja

3.5. Clinical trials

U politici razvoja Agencije posebno mesto

zauz ima interes Republike Srbije da se u
Srbiji razvije neophodna infrastruktura za
sprovoenje klinikih ispitivanja skupih i
inovativnih lekova, ime bi se pacijentima
poveala dostupnost ovakve terapije i di
jagnostike.
Pre poetka sprovoenja klinikog ispitiva
nja leka sponzor mora da podnese Agenciji
zahtev sa odobrenje klinikog ispitivanja leka
i dokumentaciju, koja sadri: saetak o pri
rodi i osobinama leka, informacije o sprove
denim istraivanjima
radi definisanja nje
govih farm
akolokih i
toksikolokih svojsta
va, kliniko iskustvo,
protokol predloenog
ispitivanja, spisak svih
istraivaa i ustanova
ukljuenih u ispitivanje
i ostala dokumenta ko
ja se odnose na zati
tu zdravlja ispitanika.
Agencija ne uzima u
razmatranje zahtev za
odobrenje klinikog is
pitivanja ukoliko Etiki
odbor ustanove u kojoj
e se kliniko ispitiva
nje sprovoditi nije dao
pozitivnu odluku o nje
mu.
Ako su ispunjeni uslo
vi propisani zakonom
i propisima donetim
za sprovoenje za
kona, Agencija izdaje
dozvolu za sprovoe
nje klinikog ispitiva
nja leka.
Kontrolu sprovoenja
klinikog ispitivanja le
ka vri Agencija u skla
du sa zakonom, proto

In the development policy of the Agency a

special place is devoted to the interest of the
Republic of Serbia to develop in Serbia the
necessary infrastructure to conduct clinical
trials of expensive and innovative medicines,
which would increase the availability of such
therapy and diagnostics to patients.
Prior to the commencement of clinical trial,
sponsor must submit to the Agency a request
for the approval of clinical trial of medicine and
documentation, which includes: a summary of
the nature and properties of medicines, information on research carried
out in order to define its
pharmacological and
toxicological properties,
clinical experience, the
proposed trial protocol,
a list of all researchers and institutions involved in the trial and
other documents relating to the protection of
health of subjects. The
Agency does not take
into consideration a
request for approval of
clinical trial if the Ethics
Committee of the institution where the clinical
trial will be conducted
did not give a favorable
opinion about it.
If the conditions laid
down by the law and
regulations governing
enforcement of the law
are met, the Agency
issues an authorization for the conduct of
clinical trial.
Supervision of the
conduct of clinical trial
is conducted by the
Agency in accordance
with the law, clini-

35
kolom klinikog ispitivanja i Smernicama Do
bre klinike prakse.
Ako doe do ozbiljne i neoekivane neelje
ne reakcije ili ozbiljnog neeljenog dogaa
ja u toku sprovoenja klinikog ispitivanja
leka sponzor je duan da odmah obavesti
Agenciju i etiki odbor pravnog lica, odno
sno zdravstene ustanove u kojoj se sprovo
di kliniko ispitivanje. U ovakvim sluajevi
ma, Agencija moe da predloi Ministarstvu
zdravlja da obustavi ili zabrani sprovoenje
klinikog ispitivanja leka, posebno ukoliko je
utvreno da je postojalo nepotovanje pro
tokola klinikog ispitivanja ili Smernica Do
bre klinike prakse.
Agencija aktivno radi na edukaciji strune i
opte javnosti o znaaju klinikih ispitivanja
i u tu svrhu je sprovodila informativne kam
panje u medijima i publikovala brouru za
uesnike i potencijalne uesnike u klinikim
ispitivanjima.
Godina / Year
2008.
2009.
2010.
2011.
2012.
2013.

cal trial protocol and Good Clinical Practice

guidelines.
If there is a serious and unexpected adverse
reaction or serious adverse event during the
conduct of clinical trial sponsor must immediately notify the Agency and the ethics
committee of the legal entity or the health
care institution where the trial is performed.
In such cases, the Agency may propose to
the Ministry of Health to suspend or prohibit
the conduct of clinical trial, particularly if it is
determined that there was non-compliance
of the clinical trial protocol and Good Clinical
Practice guidelines.
The Agency is actively involved in the education of professional and general public about
the importance of clinical trials and for that
purpose conducted information campaigns in
the media and published a brochure for participants and potential participants in clinical
trials.

Broj odobrenih klinikih ispitivanja /

Number of approved clinical trials
115
94
84
92
91
105

36
4. Laboratorijska
kontrola kvaliteta

4. Laboratory quality
control

Nacionalna kontrolna laboratorija (NKL) je

organizaciona jedinica ALIMS koja obavlja
kontrolu kvaliteta lekova i medicinskih sred
stava.
Kontrolu kvaliteta obavljaju visoko edukova
ni strunjaci, od kojih je znaajan broj proao
planiranu kontinuiranu obuku u akreditova
nim evropskim laboratorijama zemalja EU.
Obuka je realizovana u saradnji sa Evropskim
direktoratom za kvalitet lekova i brigu o zdra
vlju Saveta Evrope (EDQM).
Laboratorijska kontrola se vri u skladu sa
zahtevima Evropske farmakopeje, nacionalne
farmakopeje ili u skladu sa drugim prizna
tim farmakopejama ili proverenim metodama
analize.
NKL je opremljena najmodernijom opremom
koja je u potpunosti kvalifik ovana, kalibrisa
na i validirana u skladu sa savremenim zah
tevima.
U sastavu NKL su Fiziko-hemijska labora
torija, Bioloka laboratorija (u okviru koje se
nalaze mikrobioloka laboratorija i laborato
rija za farmakoloka ispitivanja) i Odeljenje
za upravljanjem kvalitetom i podrku.

National Control Laboratory (NCL) is an organizational unit of ALIMS that performs quality
control of medicines and medical devices.
Quality control is performed by highly trained
professionals, of whom a significant number underwent planned continuous training
in accredited European laboratories of EU
countries. The training was organized in collaboration with the European Directorate for
the Quality of Medicines and Health Care of
Council of Europe (EDQM).
Laboratory control is carried out in accordance with the requirements of the European
Pharmacopoeia, national pharmacopoeia or
in accordance to other recognized pharmacopoeias or validated methods of analysis.
NCL is equipped with the most modern
equipment that is fully qualified, calibrated
and validated in accordance with up to date
requirements.
Within the NCL there are Physico-chemical
laboratory, Biological Laboratory (in which
there are Microbiological laboratory and Laboratory for pharmacological control) and the
Quality Management and Support Unit.

Fiziko-hemijska laboratorija

Physico-chemical laboratory

U fiziko-hemijskoj laboratoriji izvode se te

stovi identifikacije, odreivanje sadraja ak
tivne supstance, brzina oslobaanja aktivne
supstance (Dissolution), ispitivanje stepena
istoe, ujednaenost doziranog oblika, ras
padljivost Karl Fisher - odreivanje sadraja
vode, odreivanje pH, odreivanje sadraja
azota, opti testovi ispitivanja i drugi farma
kopejski testovi.
Za izvoenje ovih testova koristi se savremena
oprema: Teni hromatografi pod visokim pri
tiskom sa razliitim detektorima (HPLC/VWD;
HPLC/DAD; HPLC/RID; HPLC/FLD; HPLC/MS);
Gasni hromatografi (GC; GC-HSS); Spektrofo
tometri; Infracrveni spektrofotometar; Atom
ski apsorpcioni/emisioni spektrofotometri;

In the physico-chemical laboratory identification tests are performed, determination of

content of active substance, release rate of
the active substance (Dissolution), testing the
degree of purity, uniformity of dosage forms,
disintegration Karl Fisher - determination of
moisture content, pH determination, determination of the nitrogen content, general test
and other pharmacopoeial tests.
Modern equipment is used to perform these
tests: liquid chromatography with high pressure and with different detectors (HPLC / VWD;
HPLC / DAD, HPLC / RID; HPLC / FLD, HPLC
/ MS); Gas chromatography (GC; GC-HSS),
Spectrophotometers; Infrared spectrophotometer; Atomic absorption / emission spectro-

37
HPTLC denzitometar; Dissolution aparat; Si
stem za ispitivanje raspadljivosti; Sistemi za
titraciju; Kjeldahl sistem i drugi.

photometers; HPTLC densitometer; Dissolution

apparatus; System for testing decay; Systems
for titration; Kjeldahl system and others.

Bioloka laboratorija

Biological Laboratory

Bioloku laboratoriju ine dve laboratorijske

celine, Farmakologija i Mikrobiologija, opre
mljene prema najsavremenijim standardima
za kontrolu kvaliteta lekova. U laboratoriji
radi struno osposobljeno osoblje razliitih
obrazovnih profila, ime je obezbeen multi
disciplinarni pristup prilikom svakog ispitiva
nja kvaliteta lekova.
U Biolokoj laboratoriji izvode se in vivo i in
vitro testovi koji obuhvataju razliite testove
bezbednosti, identifikacije i odreivanja sadr
aja aktivnih komponenti posebno osetljivih
grupa lekova kao to su imunobioloki lekovi
(vakcine, krvni derivati, imunoserumi i sl.).
Za ispitivanje se koristi najsavremenija opre
ma, a sama ispitivanja se izvode prema str
ogo definisanim tehnikama i procedurama
usklaenim sa Evropskom farmakopejom i
drugim vaeim regulativama (sterilnost, ne
kodljivost, odreivanje prisustva pirogenih
supstanci, odreivanje sadraja bakterijskih
endotoksina, odreivanje sadraja prekali
krein-aktivatora i sl.).
U Biolokoj laboratoriji vri se ispitivanje i
drugih grupa lekova za humanu i veterinarsku
upotrebu, koje podrazumeva rigorozna ispiti
vanja mikrobioloke istoe, i druge testove
ispitivanja biolokih karakteristika lekova.
Oprema koja se koristi za izvoenje svih te
stova podlee redovnoj kvalifikaciji i etaloni
ranju, a laboratorijski uslovi temeljno su kon
trolisani i u skladu sa najsavremenijim princi
pima Dobre laboratorijske prakse (DLP).
Bioloka laboratorija raspolae i savremeno
opremljenim vivarijumom koji slui za izvoe
nje in vivo testova.

Biological Laboratory consists of two laboratory parts, Pharmacology and Microbiology,

equipped with the latest standards for quality control of medicines. In laboratory works
professional staff of different educational
backgrounds, providing a multidisciplinary
approach to each testing of medicine quality.
In Biological Laboratory the in vivo and in
vitro tests are preformed that include various
tests of security, identification and determination of the active components of particularly
vulnerable groups of medicines such as the
immunobiological medicines (vaccines, blood
products, imunosera, etc.).
The most modern equipment is used for testing, and the tests themselves are performed
under strictly defined techniques and procedures in compliance with the European Pharmacopoeia and other applicable regulations
(sterility, safety, determining the presence
of pirogenical substances, determination
of bacterial endotoxines, determination of
prekallikrein activator, etc.).
The Biological Laboratory is dedicated to testing of other groups of medicines for human and
veterinary use, which involves rigorous testing
of microbiological purity and other tests of the
biological properties of medicines. The equipment used to perform all the tests is subject to
regular qualification and calibration, and laboratory conditions are thoroughly controlled in
accordance with the latest principles of Good
Laboratory Practice (GLP).
Biological Laboratory also has modernly
equipped vivarium used to perform in vivo
tests.

38
Odeljenje za upravljanjem
kvalitetom i podrku

Quality Management and

Support Unit

Odeljenje za upravljanje kvalitetom i podr

ku aktivno uestvuje u planiranju, organi
zovanju i koordinaciji izvrenja poslova koji
se odnose na razvoj, implementaciju, odr
avanje i poboljavanje sistema upravljanja
kvalitetom u Nacionalnoj kontrolnoj labora
toriji (NKL).
U skladu sa zahtevima standarda kvaliteta
odeljenje obavlja sledee aktivnosti: Koordi
nira aktivnosti vezane za definisanje, izradu
i izmenu specifikacija artikala potrebnih za
NKL (laboratorijska oprema, hemikalije, labo
ratorijsko staklo itd.), kao i proces prijemne
kontrole svih artikala; Koordinira i sprovodi
aktivnosti vezane za upravljanje laboratorij
skom opremom, kontrolnim uzorcima, refe
rentnim standardima i registracionom doku
mentacijom neophodnim za laboratorijsko
ispitivanje.
Ovo odeljenje takoe prati i uestvuje u spro
voenju propisa EU, ICH i drugih meunarod
nih smernica.

Quality Management and Support Unit takes

an active part in planning, organizing and coordinating the execution of tasks related to the
development, implementation, maintenance
and improvement of quality management in
the National Control Laboratory (NCL).
In accordance with the quality standards requirements the Unit performs the following
activities: Coordination of activities related
to the definition, creation and modification of
specifications of items required for NCL (laboratory equipment, chemicals, glassware, etc.),
as well as the process of receiving control of
all items; Coordinates and implements activities in management of laboratory equipment,
controls samples, references standards and
registration documentation required for laboratory testing.
This unit also monitors and participates in
the implementation of regulations by EU, ICH,
and other international guidelines.

Evropska mrea zvaninih

kontrolnih laboratorija
(OMCL Mrea)

European Official Medicines

Control Laboratories Network
(OMCL Network)

U julu mesecu 2004. godine odran je EDQM

Tutorial Visit kao deo EDQM procedure za me
unarodnu akreditaciju laboratorija u okviru
OMCL mree. Nakon procene QA sistema,
opreme, strunosti zaposlenih u NKL-u i in
formacionog sistema od strane ekspertskog
tipa EDQM-a, NKL zvanino postaje deo evr
opske OMCL mree.

In July 2004, EDQM Tutorial Visit was held as

part of EDQM procedures for international
accreditation of laboratories within OMCL
Network. After the evaluation of QA systems,
equipment, expertise of employees in NCL
and the information system by experts team
of EDQM, NCL officially became part of the
European OMCL Network.

Aktivnosti u okviru OMCL mree:

Activities within OMCL Network:

1. Proficiency Testing Scheme (PTS) studies

od 2005. godine; cilj je provera kvaliteta
rada Evropskih laboratorija i razvijanje me
usobnog poverenja;
2. Collaborative trials utvrivanje kvali
teta EP CRS (European Pharmacopoeial

1. Proficiency Testing Scheme first (PTS)

studies - since 2005; The goal is to check
the quality of work of European laboratories
and to develop mutual trust;
2. Collaborative trials - determining the qua
lity of CRS EP (European Pharmacopoeial

39
Commission of Reference Substances) - od
2006. godine;

Commission of Reference Substances) since 2006;

3. Collaborative Market Surv eillance Studi

es cilj je provera kvaliteta lekova koji se
nalaze na Evropskom tritu; od februara
2007. godine;

3. Collaborative Market Surveillance Studies

- goal is to check the quality of medicines
that are on the European market, since
February 2007;

4. Suspicious Unknown Products (Nepozna

ti uzorci lekova) identifikacija nepoznate
aktivne supstance i potom odreivanje sa
draja u dostavljenom uzorku.

4. Suspicious Unknown Products (unknown

drug samples) - identification of unknown
active ingredients and then determination
of the content in the submitted sample.

NKL uestvuje i u postavljanju osnovnog

evropskog standarda na osnovu koga se kon
troliu lekovi, odnosno u razvoju monografija
Evropske farmakopeje, a Agencija ima pred
stavnika i u grupi 15 EDQM & HealthCare za
vakcine i serume.
Konano, eksperti NKL-a redovno prisustvuju
godinjim sastancima OMCL mree u organi
zaciji EDQM-a.

NCL participates in setting the basic European

standards by which medicines are controled
that is, the development of monographs
of the European Pharmacopoeia, and the
Agency has a representative in the group 15
for vaccines and serums in the EDQM.
Finally, NCL experts regularly attend annual
meetings of OMCL Network organized by
EDQM.

40
5. Upravljanje
kvalitetom u ALIMS

5. Quality Management
in ALIMS

Upravljanje kvalitetom zauzima znaajno

mesto u poslovanju Agencije za lekove i
medicinska sredstva Srbije koja, poev od
svog osnivanja aktivno radi na implemen
taciji i unapreenju svih sistema menad
menta.
ALIMS je 8. avgusta 2006. godine uspeno
sertifikovala svoj sistem menadmenta kva
litetom (QMS) postavi tako druga agencija
u Evropi koja je ostvarila meunarodnu serti
fikaciju svog QMS-a. Pre srpske agencije se
rtifikaciju je ostvarila holandska agencija za
lekove (Medicines Evaluation Board MEB)
23. marta 2006. godine.
Sistem menadmenta kvalitetom se zasni
va na procesnom principu, ime se osigura
va kontinuirano unapreenje avih aktivnosti,
a samim tim i poboljanje kvaliteta strune
performanse Agencije.
Poseban znaaj u Agenciji ima sistem kvali
teta u skladu sa zahtevima standarda ISO
17025:2005, kojim se stalno unapreuju aktiv
nosti u postupku laboratorijske kontrole kva
liteta lekova. NKL je 26. aprila 2013. godine
i zvanino uvrtena u red akreditovanih
laboratorija od strane ATS - Akreditacionog
tela Srbije. Implementacijom zahteva ovog
strandarda Nacionalna kontrolna laboratori
ja je osigurala vodee mesto u regionu, kao i
znaajnu ulogu u OMCL mrei.
Kako je osnovno opredeljenje zaposlenih
u Agenciji kontinuirano unapreenje regu
latorne performanse u cilju obezbeenja
kvalitetnih, bezbednih i efikasnih lekova i
medicinskih sredstava za pacijente u Sr
biji, svake godine teimo da to ostvarimo
kroz unapreenje saradnje sa klijentima
Agencije i poboljanje kvaliteta usluga koje
pruamo. Analizom podataka osiguravamo
kontinuirano poveanje zadovoljstva kori
snika naih usluga, uz istovremeno usva
janje konstruktivnih predloga i kritika klije
nata u cilju postizanja kvalitetne saradnje i
transparentnosti u poslovanju.

Quality management occupies an important

place in the activities of Medicines and Medical Devices Agency of Serbia, which, from its
inception is actively working on the implementation and improvement of all management systems.
On August 8th, 2006, ALIMS successfully
certified its Quality Management System
(QMS), becoming the second agency in Europe that has achieved international certification of its QMS. Before the Serbian Agency
certification was acheived by the Dutch Medicines Agency (Medicines Evaluation Board MEB) March 23rd, 2006.
The quality management system is based
on a process basis, ensuring continuous improvement of all activities, and thus improves
the quality of professional performance of the
Agency.
Special significance in the Agency has a quality system in accordance with the requirements
of ISO 17025:2005 standard, through which
the activities in the process of laboratory quality control of medicines are constantly being
improved. NCL was officially included in the
list of accredited laboratories by Acreditation
Body of Serbia on April 26th 2013. By implementation of requirements of these standards
the National Control Laboratory has secured
a leading position in the region, as well as a
significant role in OMCL Network.
Since the basic commitment of employees in
the Agency is to continuously improve regulatory performance in order to ensure quality, safe and effective medicines and medical
devices for patients in Serbia, each year we
strive to achieve this through the promotion of
cooperation with Agencys clients and improve
the quality of services we provide. The analysis of data provides a continuous increase in
the satisfaction of our customers, while adopting constructive suggestions and criticism by
clients in order to achieve quality of cooperation and transparency in operations.

41
Takoe, aktivnosti upravljanja kvalitetom
znaajno su usmerene ka meunarodnoj
saradnji i usaglaavanju sistema menad
menta Agencije sa zahtevima Evropske
agencije za lekove koji se odnose na regu
latornu performansu nacionalnih agencija
za lekove. Od navedenih aktivnosti naroi
to je znaajno formiranje Strategije pripre
me i razvoja unutranjih kapaciteta Agenci
je za sprovoenje Benmarking procedure
(BEMA), koja obuhvata sledee oblasti:
organizacija, procena dokumentacije o le
kovima, farmakovigilanca i interakcija sa
inspekcijskim organima.
Budui da su aktivnosti upravljanja kvalite
tom involvirane u sve segmente rada Agen
cije, njegovo odravanje i kontinuirani razvoj
direktno doprinose uspostavljanju i odra
vanju visokih standarda u strunom radu
Agencije.

Also, the quality management activities are

aimed at significant international cooperation
and coordination of the Agency Management
System with the requirements of the European Medicines Agency that relate to the performance of the national regulatory agencies
for medicines. Of these activities particularly
important is creation of Strategy of preparation and development of internal capacities of Agency for Implementing Benchmarking procedures (BEMA), which includes the
following areas: organization, assessment of
documentation on medicines, pharmacovigilance and interaction with inspection bodies.
Since the activities of quality management is
involved in all aspects of the Agency work,
its maintenance and continued development
directly contribute to establishing and maintaining high standards in the professional
work of the Agency.

U Agenciji je implementiran i Sistem me

nadmenta zatitom ivotne sredine
(EMS), u skladu sa zahtevima standarda
ISO 14001:2004, koji je uspeno resertifiko
van juna 2013. godine.
EMS je znaajan za ALIMS sa vie aspekata,
od kojih treba izdvojiti upravljanje otpadom,
emisije u vodu i vazduh i mnogobrojne druge
aspekte vezano za ivotnu sredinu. Upozna
vanje svih zaposlenih u ALIMS o znaaju i na
inima zatite ivotne sredine, ali i edukacija
svih posetilaca ALIMS je takoe deo imple
mentacije ovog sistema.
Upravljanje otpadom u Agenciji zapoelo je
organizovanjem poslova postupanja, najpre
sa opasnim otpadom, da bi danas obuhvata
lo sve vrste otpada koji se generie. Naime, i
pre nego to je jula 2007. godine uveden i se

In the Agency, the Environmental Mana

gement System (EMS) is implemented in
accordance with the requirements of ISO
14001:2004 standard, which has been su
ccessfully recertified in June 2013.
EMS is important for ALIMS from several aspects, out of which the waste management
should be pointed out, as well as emissions
to water and air, and many other aspects related to the environment. Informing all employees of ALIMS about the importance and
ways to protect the environment, but also the
education of all visitors in ALIMS is also part
of the implementation of this system.
Waste management in the Agency began
by organizing work procedures, first of hazardous waste, and today includes all types
of waste generated. Namely, even before

42
rtifikovan sistem upravljanja zatitom ivotne
sredine, Agencija je demonstrirala svoju po
sveenost zatiti ivotne sredine na taj nain
to je opasan otpad koji nastaje u procesima
rada, zbrinjavala na siguran nain. Upravlja
nje otpadom regulisano je standardnim pro
cedurama i uputstvima sistema upravljanja
zatitom ivotne sredine i sistema upravlja
nja kvalitetom.
Farm
aceutski i hemijski otpad se od 2005.
godine izvoze u zemlje EU koje poseduju insi
neratore, u kojima se otpad unitava na tem
peraturama veim od 800C. Izvoz se obavlja
u skladu sa principima Bazelske konvencije o
kontroli prekograninog kretanja opasnih ot
pada i njihovom odlaganju i Agencija dobija
sertifikat da je otpad uniten u ovlaenom
postrojenju. Agencija od 2008. godine saku
plja i alje na reciklau upotrebljeni papir i
karton kao i staklo.
Pomak koji je nainjen u zatiti ivotne
sredine u naoj zemlji poslednjih godina
zahvaljujui veoj angaovanosti resor
nog Ministarstva ohrabruje i podstie da i
Agencija stalno tei unapreivanju posto
jeih postupaka.

the system of environmental management

was introduced and certified, in July 2007 the
Agency has demonstrated its commitment
to the protection of the environment in a way
that the hazardous waste generated in the
process of work was taken care of in a secure
manner. Waste management is regulated by
the standard procedures and guidance system of environmental management and quality management systems.
Pharmaceutical and chemical waste are since
2005 exported to EU countries that have incinerators, where the waste is destroyed at
temperatures higher than 800 C. Exports are
carried out in accordance with the principles of
the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes
and their Disposal and the Agency receives
certification that the waste is destroyed in an
authorized facility. Agency since 2008 has
collected and sent for recycling used paper,
cardboard and glass.
The shift that has been made in protecting
the environment in our country in recent years
due to the greater involvement of the relevant
Ministry encourages and fosters our Agency
to constantly seeks improvement of existing
processes too.

43
6. Struni skupovi u
organizaciji ALIMS edukacija
strune javnosti

6. Professional
meetings organized
by ALIMS - education of
expert public

Agencija je do sada organizovala veliki broj

strunih skupova sa meunarodnim ueem
sa prvenstvenim ciljem edukacije uesnika
u zdravstvenom sistemu Srbije. Ovim se na
dovezuje na tradiciju ovakvih skupova koja
poinje od 1972. godine kada je u Zavodu za
farmaciju odran prvi internacionalni skup po
imenu Comit des Laboratories et services
officiels de controle des Medicaments.

The Agency has so far organized a number

of conferences with international participation, with the primary aim to educate participants in the health care system of Serbia.
This builds on the tradition of such meetings,
beginning from 1972 when the Institute of
Pharmacy held its first international meeting
called Comit des Laboratories et services
de controle des officiels Medication.

icinska
ve i med
a za leko je organizuje
Agencij
Srbi
sredstva

ices
ical Dev
ng
es and Med
Medicin Serbia is organisi
of
Agency

jum

Simpozi

um

Symposi

lekovim

ilar
on Biosim
cts
al Produ
Medicin

el M
stern Hot bar 200
Best We
24. novem
Beograd

8.

el M
stern Hot ember 2008
Best We
24th Nov
Belgrade,

44
Pored ovoga, strunjaci Agencije su lanovi
velikog broja meunarodnih udruenja i aso
cijacija i redovno uestvuju na relevantnim
sastancima, skupovima i kongresima na ko
jima izlau radove, dre predavanja i predsta
vljaju nau zemlju.
U budunosti, Agencija e se fokusirati na
edukaciju zdravstvenih profesionalaca u
oblasti farmakovigilance sa ciljem poveanja
broja prijava neeljenih dejstava i ovi skupo
vi e biti akreditovani od strane Zdravstvenog
saveta Srbije.

In addition, experts from the Agency are

members of many international associations,
and regularly participate in relevant meetings, conferences and congresses at which
they exhibit papers, lectures and represent
our country.
In the future, the Agency will focus on the
education of health professionals in the field
of pharmacovigilance in order to increase the
number of reports of adverse effects, and
these meetings will be accredited by the
Health Council of Serbia.

13:00-14:00 Lunc

ion

After noon Sess

networking
the decisions:
y Assessment
Assessment of
Health Technolog
International
rde
illance
Caroline Labo illance, consumption surve
g surve
rtisin
Adve
14:30-15:10
broucq
Georges Haze

14:00 -14:30

15:10-15:25
15:25- 16:25
16:25-17:00

Coffee break
py
diabetes thera
Concrete case:
rde
Caroline Labo
D1-D2
cq
Debriefing of
ges Hazebrou
rde and Geor
Caroline Labo
th

Third day, 11

February 2009

)
prospective...
ent situation,
cq
situation (curr
The Serbian
ges Hazebrou
rde and Geor
Caroline Labo
broucq
Georges Haze
nuctio
Introd
Stefanovic
10:00-10:10
ntation-Danka
ALIMS prese
h
10:10-10:25
Ministry of Healt Health Insurance
10:25-10:40
ute of
Serbian Instit
10:40-10:55
10:55-11:15

Coffee break

11:15-14:00
14:00

i
Agencia za lekove rbie
medicinska sredstva
Medicines and
Agency of Serbia
Medical Devices
ruacia domai
roizvoaa lekova Manufacturers
Local
Association of
of Medicinal Products
stvom
rbie
od okrovitel
a eublike
Ministarstva zdravlof
Under the Auspices the Republic of Serbia
of
Ministry of Health

Discussion and

conclusions
g

Certificate issuin

uz odrku
a
druena roizvoa
VA
inovativni lekova
unareivane
i druena za
a - K
kliniki isitivan
With support of
the Manufacturers
Association of
INOVIA
Drugs
e
of Innovativ
for Advancement
and Association
of Serbia - KLINIS
of Clinical Research

simpozijum
9. tradicionalni
Symposium
9th Traditional

Programme

Vrac
bra
15 - 16. novem
15
2013. godin e
ka
Kongresno- muzi a
dvora na Centr
Millen nium AD
Vrsac
ber 2013
t
15t -16 ovem
Music all
Congress and
Millen nium AD
o t e Centre

45
7. Publikacije ALIMS

7. ALIMS Publications

NRL i NRVL
Nacionalni registri lekova (NRL) odnosno
Nacionalni registar veterinarskih lekova
(NRVL) su prirunici za farmaceute i lekare,
odnosno veterinare koji sadre farmakoinfor
matike podatke neophodne za propisivanje
i izdavanje lekova i druge korisne informaci
je za sprovoenje farmaceutske zdravstvene
zatite, odnosno za pruanje farmaceutskih
zdravstvenih usluga.

NRL and NRVL

National Registry of Medicines (NRL) and
the National Register of veterinary medicines
(NRVL) are guides to physicians and pharmacists, or veterinarians who contain the pharmakoinformatical information necessary for
prescribing and dispensing of medicines and
other useful information for the implementation of pharmaceutical care and providing
pharmaceutical health services.

46
Promet i potronja lekova
U skladu sa Zakonom o lekovima medicinskim
sredstvima, ALIMS prikuplja i obrauje po
datke o prometu i potronji lekova u Srbiji i
publikuje ih na godinjem nivou. U ovim knji
gama se nalaze zdravstveno-ekonomski i
statistiki pokazatelji kao i farm
ako-epidemi
oloki pokazatelji upotrebe lekova iz kojih se
mogu izvoditi analize a sve sa ciljem da bu
du od koristi dravnim institucijama ali i svim
uesnicima u prometu lekova u Srbiji.

Marketing and consumption of medicines

In accordance with the Law on Medicines
and medical devices, ALIMS collects and processes data on marketing and consumption
of medicines in Serbia and publishes them
annually. In these books, there are healtheconomic and statistical indicators, as well
as pharmaco-epidemiological indicators of
medicines use from which the analysis can
be developed with the goal of being used by
state institutions and all participants in the
medicines market in Serbia.

Farmakoterapijski vodi
Farm
akoterapijski vodi je publikacija koja
sadri informacije o profilima lekova, organi
zovana u skladu sa ATC klasifikacijom o me
dicinskim proizvodima sa brojnim farmakoin
formatikim podacima u vezi sa bezbednom
primenom lekova.

Pharmacotherapy Guide
Pharmacotherapy Guide is a publication
which contains information on the profiles of
medicines, organized according to the ATC
classification of medical devices with numerous pharmakoinformatical data related to the
safe use of medicines.

Ostale publikacije
Agencija je objavila ili podrala objavljivanje
velikog broja strunih publikacija, meu koji
ma treba izdvojiti Magistralne form
ule (2008).

Other publications
Agency published or supported the publication of a large number of expert publications,
among which Magisterial formulas (2008)
should be pointed out.

47
8. Internet stranica
ALIMS

8. ALIMS Website

Internet stranica Agencije (www.alims.gov.rs)

omoguava Agenciji da postigne transparent
nost u radu i da na jednostavan nain uini
dostupnim sve relevantne informacije o radu
i rezultatima rada Agencije za zdravstvene
radnike, pacijente i farmaceutsku industriju.
Najznaajnije opcije na Internet stranici su:
pretraivanje lekova, medicinskih sredstava,
veterinarskih lekova i klinikih ispitivanja, kao
i pretraivanje sertifikata odobrenih serija.
Na Internet stranici se klijenti Agencije mo
gu obavestiti o svim procedurama koje se
sprovode u Agenici kao i zakonskoj regu
lativi koja se odnosi na poslove iz delokru
ga Agencije i najzad, proveriti stanje svog
zahteva.
Na Internet stranici se publikuju i obavete
nja i saoptenja Agencije za nosioce dozvola,
strunu i optu javnost, stanica sadri i kori
sniki serv is a preko nje se mogu i postaviti
pitanja Agenciji.
Konano, preko Internet stranice Agencije se
moe prijaviti neeljena reakcija na humani i
veterinarski lek, kao i neeljena reakcija na
medicinsko sredstvo, ukljuujui i online
prijavu.

Agencys website (www.alims.gov.rs) allows

the Agency to achieve transparency in its work
and in a simple way make available all relevant information about the work and achievements of the Agency for health care workers,
patients and the pharmaceutical industry.
The most important features on the website
include: Search option for the medicines,
medical devices, veterinary medicines and
clinical trials, as well as Search of the series
certificates.
On the website, the Agency clients are notified
of any procedures that are performed in the
Agency and legislation relating to procedures
from the scope of the Agency, and finally, they
can check the status of their request.
The notifications and statements from the
Agency to the Marketing Authorization holders, professional and general public are published on the website, and this web page
includes customer service and through that
questions to the Agency can be asked.
Finally, through the Agencys website adverse reactions on human and veterinary
medicines, as well as adverse reactions to
medical devices can be reported, including
the online application.

48
Agencija za lekove i medicinska sredstva
Srbije - ALIMS
Vojvode Stepe 458,
11221 Beograd, Srbija
www.alims.gov.rs
i-mejl: hygia@alims.gov.rs
Direktor
Spec. dr. med. Saa Jaovi
Urednik
Mag. farm. Pavle Zeli
Izdava
Helicon Publishing, Panevo
Za izdavaa
Velimir ivkovi
tampa
Helicon Publishing, Panevo
Tira
500

Medicines and Medical Devices Agency of

Serbia - ALIMS
458, Vojvode Stepe Street,
Belgrade 11221, Serbia
www.alims.gov.rs
e-mail: hygia@alims.gov.rs
Managing Director
Sasa Jacovic, M.D., sp.
Editor
Pavle Zelic, Phar.M.
Publisher
Helicon Publishing, Pancevo
On behalf of Publisher
Mr. Velimir Zivkovic
Production
Helicon Publishing, Pancevo
Printing
500