EMA Glossary 2009 EN-IT Validated

32
EN
EN
Abbrev
EN Source
Audit Advisory Committee
AAC
EMA Annual Report 2005
EN Definition
Accounting Sector
EMA organigramme, URL: http://www.ema.eu.int/htms/aboutus/organigra
Administration Unit
EMA organigramme, URL:

http://www.ema.eu.int/htms/aboutu
s/organigramme.htm
Committee for Medicinal

Products for Human Use
CVMP
Committee for Medicinal
Products for Veterinary Use
CHMP
EMA Glossary 2008
Committee on Herbal
Medicinal Products
CHMP
EMA Glossary 2008
Committee on Orphan
Medicinal Products
COMP
EMA Glossary 2008
Communications and
Networking Unit

http://www.ema.eu.int/htms/about
us/organigramme.htm
Document Management and

Publishing Sector

us/organigramme.htm
Executive Support Sector

us/organigramme.htm
10
Head of Sector
11
Head of Unit
12
Information Technology
Sector

us/organigramme.htm
13
Infrastructure Services
Sector

us/organigramme.htm
14
Inspections Sector

us/organigramme.htm
15
Integrated Quality and Audit

Sector

us/organigramme.htm
16
Legal Sector

us/organigramme.htm
17
Medical Information Sector
18
Meeting Management and

Conferences Sector

us/organigramme.htm
19
Personnel and Budget

Sector

us/organigramme.htm
20
Pharmacovigilance and
Post-authorisation Safety
and Efficacy of Medicines
Sector

us/organigramme.htm
21
Post-authorisation
Evaluation of Medicines for
Human Use Unit

s/organigramme.htm
22
Pre-authorisation Evaluation
of Medicines for Human Use
Unit

s/organigramme.htm
23
Project Management Sector

us/organigramme.htm
24
Quality of Medicines Sector

us/organigramme.htm
MIS

s/organigramme.htm
25
Regulatory Affairs and

Organisational Support
Sector

us/organigramme.htm
26
Safety and Efficacy of

Medicines Sector

us/organigramme.htm
27
Safety of Veterinary
Medicines Sector

us/organigramme.htm
28
Scientific Advice and

Orphan Drugs Sector

us/organigramme.htm
29
scientific committee
EMA Glossary 2008
30
Veterinary Marketing
Authorisation Procedures
Sector

us/organigramme.htm
31
Veterinary Medicines and

Inspection Unit

s/organigramme.htm
33
Central Information Group
34
CMD(h)
Coordination group for
Mutual recognition and
Decentralised procedures Human
CIG
The EMA Code of Conduct (CDT

internal document
EMA/6470/03/2368); URL:
http://www.ema.europa.eu/htms/h
uman/postguidance/q03.htm
Art. 27-28 of EC Directive

83/2001, as amended,
CELEX:32001L0083
35
CMD(v)
Coordination group for
Mutual recognition and
Decentralised procedures Veterinary
Art. 31-32 of EC Directive

82/2001, as amended,
CELEX:32001L0082
36
CVMP Working Party
EMA website, URL:

www.ema.europa.eu/pdfs/vet/regaf
fair/032904en.pdf
37
EMA Human Scientific

Committees Working Party
with Patients and
Consumers Organisations
38
EMA/CHMP Working Group HCP's

organisatio
with Healthcare
n
Professionals' Organisations
39
Environmental Risk
Assessment Working Party
40
International Conference on ICH

Harmonisation of Technical
Requirements for
Registration of
Pharmaceuticals for Human
Use
EMA website, URL:

http://www.ema.europa.eu/Inspecti
ons/ICH.html
41
International Cooperation on VICH

Harmonisation of Technical
Requirements for
Registration of Veterinary
Products
EMA Glossary 2008
42
Invented Name Review

Group
43 Mutual Recognition
Facilitation Group
PCWP
ERAWP
EMA website, URL:

http://www.ema.europa.eu/htms/g
eneral/contacts/CHMP/CHMP_PC
WP.html
EMA website, URL:

http://www.ema.europa.eu/pdfs/ge
neral/direct/emawp/37423005en.p
df
NRG
MRFG
PCWP
EMA website, URL:

http://www.ema.europa.eu/htms/g
eneral/contacts/CHMP/CHMP_PC
WP.html
44
Patients' and Consumers'

Working Party
45
Patients/Consumers'
Organisations consultation
EMA website, URL:

http://www.ema.europa.eu/pdfs/hu
man/pcwp/16166005en.pdf
46
quality review of documents QRD
EMA website, URL:

http://pim.ema.europa.eu
47
Specialised Group Antiinfectives/Immunology
EMA PLUS
Specialised Group
CNS/Endocrinology
49 Specialised Group
Oncology/CVS
EMA PLUS
50
Therapeutic Group Antiinfectives

51 Therapeutic Group CNS
EMA PLUS
52
Therapeutic Group
Endocrinology
53 Therapeutic Group
Oncology
54 accuracy
EMA PLUS
55
Glossary of Pharmaceutical Terms

(c) Bausch & Lomb
Pharmaceuticals. Revised: August
31, 1998
48
active ingredient
EMA PLUS
EMA PLUS
EMA PLUS
EudraLex, vol. 3A ; Epilex
Any component that is
intended to furnish
pharmacological
activity or other direct
effect in the diagnosis,
cure, mitigation,
treatment, or
prevention of disease,
or to affect the
structure or any
function of the body of
man or animals.
56
active substance
Guideline on the chemistry of new

active substances, EMA, URL:
man/qwp/013096en.pdf
57
adjuvant
EMA Template
58
adverse drug reaction
ADR
59
adverse event
AE, ADE ICH Topic E 2 A, Clinical Safety
ICH Topic E 2 A, Clinical Safety

Data Management: Definitions and
Standards for Expedited
Reporting, EMA, URL:
man/ich/037795en.pdf
Data Management: Definitions and

Standards for Expedited
Reporting, EMA, URL:
man/ich/037795en.pdf
60
Anatomical, Therapeutic and ATC

Chemical classification
system
EMA website, URL:

www.ema.europa.eu/pdfs/vet/sop/
4019SOP.pdf
61
applicant
EMA website, URL:

man/regaffair/7540106en.pdf
62
application for a centralised

marketing authorisation
Annual report of the European

Medicines Agency 2005
63
arbitration
EMA website, URL:

http://www.ema.europa.eu/htms/ge
neral/contacts/CHMP/CHMP.html
64
arbitration and referral
EMA Work Program 2006
65
assessment report
EMA Template
66
batch number
EMA Template
67
batch release
EMA Template
68
benefit-risk assessment
69
benefit-risk balance

70
centralised application

71
centralised marketing
authorisation application

72
centralised procedure;
centralised evaluation
procedure; centralised
Community authorisation
procedure
Council Regulation (EEC) No

2309/93, CELEX:31993R2309
73
centralised product

74
certificate of a medicinal
product
EMA website, URL:

www.ema.europa.eu/Inspections/C
ertificates.html
75
CHMP/CVMP opinion

One of 2 EU
procedures for the
granting of marketing
authorisations. The
centralised procedure
is compulsory for
medicinal products
derived from
biotechnology, and
available at the
request of applicants
for other innovative
new products.
Applications are
submitted directly to
the European Agency
for the Evaluation of
Medicinal Products
(EMA) in London.
76
clinical aspect
EMA website, URL:

http://www.ema.europa.eu/humand
ocs/PDFs/EPAR/Viramune/H-183en8b.pdf
77
Codex Alimentarius

78
Community herbal
monograph

79
Community marketing
authorisation

80
Community procedure for

the authorisation and
supervision of medicinal
products for human and
veterinary use
Council Regulation (EEC) No

2309/93 of 22 July 1993 laying
down Community procedures for
the authorization and supervision
of medicinal products for human
and veterinary use and
establishing a European Agency
for the Evaluation of Medicinal
Products
81
Community referral

82
compassionate use

83
competent authority
EMA site, URL:

84
conditional marketing
authorisation
EMA site, URL:

85
contraindication

86
Coordination of EU PhV
EMA PLUS
87
co-rapporteur

88
corporate risk-management
89
Crisis Management Plan for

Centrally Authorised
Products
90
CVMP opinion

91
decentralised marketing
European Medicines Registration

Consultancy Limited website, URL:
http://www.emrc.ie/ourservices.html
92
decentralised procedure
Council Directives 93/39/EEC,

93/40/EEC and 93/41/EEC
93
EPAR summary

94
establishment of a maximum MRL

residue limit

95
EU Risk Management Plan EU-RMP
EMA site, URL:

man/euleg/9626805en.pdf
One of 2 procedures in
the EU for the granting
of marketing
authorisations. The
decentralised
procedure (also known
as the mutual
recognition procedure)
applies to the majority
of conventional
medicinal products
and is based upon the
principle of mutual
recognition of national
authorisation
procedures.
96
EU Risk Management
Strategy
ERMS
97
EU Telematics Strategy
98
European Public
Assessment Report
99
European registration
system
EMA press release, URL:

www.ema.europa.eu/pdfs/human/p
ress/pr/092197en.pdf
100
European Risk-management ERMS

Strategy
101
evaluation phase

102
exceptional circumstances
EMA site, URL:

103
excipient
EMA website, URL:

www.ema.europa.eu/pdfs/human/p
roductinfo/3bc7a_200307en.pdf
104
expert advice
EMA website, URL:

www.ema.europa.eu/Inspections/
docs/23948607en.pdf
105
expiry date

106
extension
107
extension of indication

108
external use of an herbal

product
EMA site, URL:

man/hmpc/3189706en.pdf

EPAR

109
fee exemption
POLICY FOR CLASSIFICATION

AND INCENTIVES FOR
VETERINARY MEDICINAL
PRODUCTS INDICATED FOR
MINOR USE MINOR SPECIES
(MUMS)/LIMITED MARKETS,
EMA, URL:
www.ema.europa.eu/pdfs/vet/iwp/4
2908009en.pdf
FUM
110
follow-up measure
111
food-producing species

112
food-producing animal

113
full application
EMA website, URL:

www.ema.europa.eu/htms/general/
admin/fees/feesh.htm
114
generic
EMA site, URL:

115
guidance
Directive 2001/20/EC,
CELEX:32001L0020
116
herbal medicinal product for

human use
117
herbal preparation
EMA website, URL:

118
herbal substance
EMA website, URL:

119
hybrid
EMA website, URL:

ICH guideline on risk

management
121 immunological medicinal
product
122
immunological
123
infectious agent
EMA website, URL:

120
124
informed consent
DIRECTIVE 2001/83/EC OF THE

EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 6 November
2001, CELEX:32001L0083
125
initial evaluation
126
initial marketing
127
innovative therapy
128
interaction

129
International Nonproprietary INN

Name
EMA EPAR Template
130
invented name

131
linguistic post-opinion
checking procedure
132
linguistic review
EMA website, URL:

133
mandatory scope of the

134
EMA website, URL:

M.A., MA Annual report of the European
135
application
136
holder
EMA website, URL:

MAH

The legal entitiy to

whom a marketing
authorisation is
granted and who must
meet all conditions and
perform all obligations
imposed by the
authorisation. In
particular the MAH
must meet all
pharmacovigilance
requirements.
MRL
137
maximum residue limit
138
medication error
EMA website, URL:

139
medicinal product for human

use

140
medicinal product for

veterinary use

141
minor species

142
minor use and minor species MUMS

143
mock-up
EMA website, URL:

144
mutual recognition

145
mutual recognition
agreement
MRA


146
mutual recognition
procedure
147
national competent authority

148
national competent authority

partner

149
national marketing
Finish Medicines Agency Fimea

website, URL:
http://www.nam.fi/pharma_industry
/marketing_authorisation/applying
150
national procedure
EMA website, URL:

151
new substance

152
Notice to Applicant
EMA website, URL:

www.ema.europa.eu/pdfs/human/e
wp/022502en.pdf
153
optional scope of the

Guideline concerning the optional

scope of the centralised
procedure in accordance with
Article 3(2)(b) of
Regulation (EC) No 726/2004,
URL:
http://ec.europa.eu/enterprise/pha
rmaceuticals/pharmacos/docs/doc
2005/1205/optional_scope_publ_21_12_0
5.pdf
154
orphan drug
EMA website, URL:

www.ema.europa.eu/htms/human/
orphans/guidance.htm
MRP

155
orphan medicinal product for

human use
156
other novel design
EMA website, URL:

157
parallel distribution
158
parallel import
EMA website, URL:

http://www.ema.europa.eu/pdfs/eu
enlargement/136702en.pdf
159
Periodic Safety Update

Report
PSUR

160
pharmaceutical form

161
pharmacological property
III Scientific Discussion, EMA,

URL:
www.ema.europa.eu/vetdocs/PDF
s/EPAR/Pruban/V-048-en6.pdf
162
pharmacovigilance

163
pharmacovigilance and
maintenance activity

164
pharmacovigilance system
EMA website, URL:

neral/contacts/CVMP/CVMP_PhV
WP-V.html
The systematic
surveillance of the
safety of medicinal
products once they are
actually placed on the
market and in use by
patients. In addition to
pharmacovigilance,
marketing
authorisation holders
have an obligation to
provide periodic safety
update reports.
165
PhV inspection
WORK PLAN FOR AD HOC

PHARMACOVIGILANCE
INSPECTORS WORKING
GROUP (PhV IWG) FOR 2009,
EMA, URL:
http://www.ema.europa.eu/Inspect
ions/docs/phv/phviwg_workplan20
09.pdf
166
PhV regulatory obligation
Pharmacovigilance Inspection
Policy for Centralised ProceduresMedicinal Products for Veterinary
Use, EMA, URL:
http://www.ema.europa.eu/Inspect
ions/docs/phv/38464608en.pdf
167
points to consider document
EMA website, URL:

man/swp/037201en.pdf
168
post-authorisation activity

169
post-authorisation phase

170
post-marketing

171
post-marketing surveillance
EMA press release, URL: http://www.ema.europa.eu/pdfs/general/direct
172
post-opinion phase

173
pre-submission

174
pre-submission discussion
with future applicant
175
Product Information (SPC,

labelling and package
leaflet)
176
progress report
EMA website, URL:

http://www.ema.europa.eu/pdfs/eu
enlargement/conferences/1progre
ssreport.pdf
177
protocol assistance

178
provisional MRL
EMA press release, URL:

http://www.ema.europa.eu/pdfs/vet
/press/pr/028701en.pdf
PI
EMA website, URL:

uman/qrd/qrdplt/24530905en.pdf
179
Q&A on refusal
EMA website, URL:

180
Q&A on withdrawal of
application
EMA website, URL:

http://www.ema.europa.eu/human
docs/PDFs/EPAR/ximelagatran/60
46506en.pdf
181
QRD template
EMA website, URL:

182
quality risk-management
approach
183
quality, safety and efficacy of

a medicinal product

184
question & answer process
EMA website, URL:

185
rapporteur

186
rapporteurship
CHMP RAPPORTEUR/CORAPPORTEUR APPOINTMENT:

PRINCIPLES, OBJECTIVE
CRITERIA and METHODOLOGY,
EMA, URL:
187
readability
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc200
188
re-examination of an opinion
GUIDELINE ON THE
READABILITY OF THE LABEL
AND PACKAGE LEAFLET OF
MEDICINAL PRODUCTS
FOR HUMAN USE, URL:
189
referral

190
referral procedure

191
refusal of marketing
authorisation

192
registry
EMA website, URL:

193
regulator

194
regulatory and procedural

advice
195 regulatory framework
196
regulatory review
EMA website, URL:

197
regulatory system

198
renewal
EMA website, URL:

man/regaffair/299000.pdf
199
revocation of marketing
authorisation

200
risk communication
EMA website, URL:

201
risk management system
EMA website, URL:

202
risk management system

evaluation
EMA website, URL:

203
risk minimisation activity
EMA website, URL:

204
risk/benefit analysis

205
risk/benefit evaluation
206
risk management
207
risk-management plan
208
route of administration

209
routine pharmacovigilance
EMA website, URL:

210
Rules Governing Medicinal

Products in the European
Union

211
safety profile
EMA website, URL:

http://www.ema.europa.eu/htms/hu
man/postguidance/q73.htm
212
scientific advice
213
scientific conclusion
EMA website, URL:

http://www.ema.europa.eu/htms/hu
man/epar/eparintro.htm
EMA website, URL:

214
scope mandatory indication
215
Standard Operating
Procedure
SOP
EMA website, URL:

neral/sop/sop.htm
216
summary of product
characteristics
SPC

217
sunset clause
EMA website, URL:

uman/postguidance/18007905en.
pdf
218
suspension

219
trade name
EMA website, URL:

220
traditional herbal medicinal

product

221
type I variation

222
type II variation

223
under evaluation

224
user consultation
EMA website, URL:

uman/qrd/qrdplt/27737805en.pdf
225
user testing
GUIDELINE ON THE
READABILITY OF THE LABEL
AND PACKAGE LEAFLET OF
MEDICINAL PRODUCTS FOR
HUMAN USE, URL:
http://ec.europa.eu/enterprise/pha
rmaceuticals/pharmacos/docs/doc
2006/09_2006/readability_consult
ation_2006_09_25.pdf
226
validation
Epilex
227
variation to marketing
authorisation

228
veterinary medicinal product

for food-producing animals
229
withdrawal of marketing

230
withdrawal period

231
case-control study
EMA website, URL:

232
clinical trial

233
cohort study
EMA website, URL:

234
comparative observational
study
EMA website, URL:

235
cross-sectional study
EMA website, URL:

236
drug utilisation study
EMA website, URL:

237
epidemiological method for

a post-authorisation safety
study
EMA website, URL:

238
Good Clinical Practice
GCP

239
Good Laboratory Practice
GLP

240
Good Manufacturing
Practice
GMP

241
intensive monitoring scheme
242
large simple trial
EMA website, URL:

LST
EMA website, URL:

243
method for active

surveillance
EMA website, URL:

244
occurrence of disease
EMA website, URL:

245
pharmacodynamic data

246
pharmacokinetic analysis
247
pharmacological class effect
EMA website, URL:

248
Phase III study

249
prescription event
monitoring
PEM
250
sentinel site
EMA website, URL:

251
specimen
EMA website, URL:

252
stability testing

253
change control process
EMA website, URL:

254
common name
Directive 2001/83/EC of the

European Parliament and of the
Council of 6 November 2001 on
the Community code relating to
medicinal products for human
use, CELEX:32001L0083
255
Common Technical
Document
CTD
EMA website, URL:

Method of active
http://www.ema.europa.eu/pdfs/hu pharmacovigilance
surveillance in which
patients might be
identified from
electronic prescription
data or automated
health insurance
claims. A follow-up
questionnaire can then
be sent to each
prescribing physician
or patient at
prespecified intervals
to obtain outcome
information.
ICH website, URL:

http://www.ich.org/cache/compo/2
76-254-1.html
256
Data Exchange Standard
DES
EMA website, URL:

257
electronic Common
Technical Document
eCTD
ICH website, URL:

http://www.ich.org/cache/compo/2
76-254-1.html
258
European Pharmaceutical
Products database
EudraPhar
m, EPh
PIM Project, EMA, URL:

http://pim.ema.europa.eu/doc/EMA
%20PIM%20glossary%20%20public.pdf
eXtensible Markup
Language
260 human safety database
XML
EMA website, URL:

261
Light Authoring Tool
LAT
262
PIM Review System
PRS
263
Product Information
Management
PIM
259
EMA website, URL:

EMA website, URL:
EMA website, URL:
EMA website, URL:

System built by
and installed at
the EMA, which is
made available
via Eudranet to
users in Member
State (MS)
National
Competent
Authorities only
who are
responsible for
reviewing the
data in all of the
countries of the
European Union.
EN Definition
Source
EN Note
IT
comitato consultivo di audit
IT Abbrev
comitato consultivo di audit
gruppo centrale delle informazioni
gruppo di coordinamento per le procedure di

mutuo riconoscimento e decentrate medicinali per uso umano
gruppo di coordinamento per le procedure di

mutuo riconoscimento e decentrate medicinali veterinari
gruppi di lavoro del CVMP
gruppo di lavoro dei comitati scientifici

dell'EMA per i medicinali per uso umano con le
associazioni dei pazienti e dei consumatori
gruppo di lavoro dell'EMA/CHMP con le

associazioni degli operatori sanitari
gruppo di lavoro per la valutazione dei rischi

ambientali
conferenza internazionale sull'armonizzazione
dei requisiti tecnici per la registrazione di
medicinali per uso umano
Cooperazione internazionale per

l'armonizzazione dei requisiti tecnici per la
registrazione di medicinali veterinari
gruppo per l'esame del nome di fantasia

gruppo per la facilitazione del mutuo
riconoscimento
gruppo di lavoro dei pazienti e dei consumatori
consultazione delle associazioni di

pazienti/consumatori
revisione della qualit dei documenti
gruppo specializzato su
antinfettivi/immunologia
gruppo specializzato su sistema nervoso

centrale/endocrinologia
gruppo specializzato su oncologia/sistema
cardiovascolare
gruppo terapeutico sugli antinfettivi
gruppo terapeutico sul sistema nervoso
centrale
gruppo terapeutico sull'endocrinologia
gruppo terapeutico sull'endocrinologia
accuratezza
Glossary of
Pharmaceutical
Terms (c) Bausch
& Lomb
Pharmaceuticals.
Revised: August
31, 1998,
http://www.blpharm
.com/Glossary.htm
According to the
Compilation of
QRD decisions on
the use of terms, v
2.0, the use of this
term is to be
avoided. Instead,
'active substance'
should be used.
ingrediente attivo; principio attivo
According to the
Compilaton of QRD
decisions on the
use of terms, v 2.0,
this is the preferred
term.
sostanza attiva; principio attivo
adiuvante; coadiuvante
reazione avversa al farmaco
To be used where it
occurs during the
use of a medicinal
product but its
causal relationship
is not yet
established.
(Compilation of
QRD decisions on
the use of terms, v
2.0 (EMA
document))
evento avverso; reazione negativa
sistema di classificazione anatomica

terapeutica chimica
richiedente
domanda di autorizzazione all'imissione in

commercio mediante procedura centralizzata
arbitrato
arbitrati e deferimenti
relazione di valutazione
numero del lotto
rilascio dei lotti; rilascio dei lotti di

fabbricazione
valutazione rischio/beneficio
rapporto rischi/benefici
domande di autorizzazione all'imissione in

commercio centralizzata
domanda di autorizzazione all'imissione in
commercio mediante procedura centralizzata
pharmalicensing.c
om, URL:
http://pharmalicens
ing.com/public/artic
les/view/99434601
0_3b44841a653f7
procedura centralizzata
prodotto centralizzato
certificato di medicinale
parere del CHMP/CVMP
aspetti clinici
Codex alimentarius
monografie comunitarie sulle piante medicinali
autorizzazione comunitaria di immissione in

commercio
procedure comunitarie per l'autorizzazione e la

vigilanza dei medicinali per uso umano e
veterinario
deferimenti comunitari
uso compassionevole
autorit competenti
autorizzazione condizionale all'immissione in

commercio
controindicazioni
coordinamento della farmacovigilanza europea

correlatore; co-relatore
gestione dei rischi interni

piano di gestione dei rischi dei medicinali
autorizzati mediante procedura centralizzata
pareri del CVMP
domanda di autorizzazione all'immissione in

commercio mediante procedura decentrata
EMA/PERF/Manda
te/027/2000 Rev.2
procedura decentrata
sintesi dell'EPAR; riassunto dell'EPAR
determinazione di limiti massimi di residui
piano di gestione dei rischi dell'UE
strategia di gestione dei rischi dell'UE
strategia telematica dell'UE
relazione pubblica di valutazione europea
sistema europeo di registrazione
strategia europea di gestione dei rischi
fase di valutazione
circostanze eccezionali
eccipiente
parere di un esperto
data di scadenza
estensione
estensione dell'indicazione
uso esterno di prodotti vegetali
EPAR
esenzione dei diritti
misura di follow-up
specie destinate alla produzione di alimenti
animali destinati alla produzione di alimenti
domanda completa
generico
indicazioni
medicinali vegetali per uso umano
preparato vegetale
sostanza vegetale
ibrido
linea guida ICH sulla gestione dei rischi

medicinali immunologici
immunologici
agenti infettivi
consenso informato
valutazione iniziale
domanda iniziale di autorizzazione
all'imissione in commercio
terapie innovative
interazioni
denominazione comune internazionale
nome di fantasia
procedura di revisione linguistica successiva al

parere
revisione linguistica
campo d'applicazione obbligatorio della

Under EU
legislation, no
medicinal product
may be placed on
the market unless a
marketing
authorisation has
been granted by
the appropriate
competent authority
(Article 3 of Council
Directive
65/65/EEC).
(EMA/PERF/Manda
te/027/2000 Rev.2)
autorizzazione all'immissione in commercio

commercio
EMA/PERF/Manda
te/027/2000 Rev.2
titolare dell'autorizzazione all'immissione in

commercio
limiti massimi di residui
errori medici
medicinali per uso umano
medicinali veterinari
specie minori
usi minori e specie minori
modello
mutuo riconoscimento
accordi di mutuo riconoscimento
MRL
procedura di mutuo riconoscimento
autorit nazionali competenti
partner delle autorit nazionali competenti

commercio mediante procedura nazionale
procedura nazionale
nuove sostanze
avviso ai richiedenti
campo d'applicazione facoltativo di una

medicinali orfani; farmaci orfani
medicinale orfano per uso umano
altre metodologie innovative
distribuzione parallela
importazione parallela
rapporto periodico di aggiornamento sulla

sicurezza ; relazione periodica di
aggiornamento sulla sicurezza
forma farmaceutica
propriet farmacologiche
EMA/PERF/Manda
te/027/2000 Rev.2
farmacovigilanza
farmacovigilanza e attivit di mantenimento
sistemi di farmacovigilanza
ispezioni di farmacovigilanza
obblighi di farmacovigilanza previsti dalla

legge
documento contenente i punti da considerare
attivit successive all'autorizzazione
fase successiva all'autorizzazione
post-immissione in commercio
Term used to
describe sections of
the regulations
requiring the
collection and
monitoring of safety
and efficacy
information about a
medicinal product
or device after it is
approved and
marketed.
(http://www.healthiq
.com/HealthcareRe
sources/Glossary/G
353.htm)
vigilanza post-marketing; vigilanza successiva VET

all'immissione in commercio; controlli postimmissione in commercio
fase successiva all'emissione del parere
periodo precedente alla presentazione della

domanda
discussione con i futuri richiedenti precedente
la presentazione della domanda
informazioni sul prodotto
relazione sullo stato di avanzamento
assistenza all'elaborazione del protocollo
MRL provvisorio
domande e risposte sul rifiuto di una domanda
domande e risposte sul ritiro di una domanda
formati standard elaborati dal QRD

orientamenti della gestione della qualit dei
rischi
qualit, sicurezza ed efficacia dei medicinali
processo a domande e risposte

relatore
relatori e correlatori
leggibilit
riesame dei pareri
deferimento
procedura di deferimento
rifiuto di un'autorizzazione all'immissione in

commercio
registri
regolatori
consulenza regolatoria e procedurale

quadro normativo; contesto regolatorio
revisione regolatoria
sistema regolatorio
rinnovo
revoca dell'autorizzazione all'immissione in

commercio
comunicazione dei rischi
sistema di gestione dei rischi
valutazione del sistema di gestione dei rischi
attivit di minimizzazione dei rischi
analisi del rapporto rischi/benefici
valutazione del rapporto rischi/benefici
gestione dei rischi

piani di gestione dei rischi
via di somministrazione
farmacovigilanza di routine
Norme che disciplinano i medicinali

nell'Unione europea
profilo di sicurezza
parere scientifico; consulenza scientifica

conclusioni scientifiche
Term does not ricorso all'indicazione obbligatoria

exist as such in
source
indicated by
EMA.
"Mandatory
indication" is a
term which is
quite broadly
used in the
context of food
labelling
(http://www.fsai
.ie/consultation
s/info_2006041
0.pdf) but it can
also appear in
the medical
context, (e.g.
http://www.simi
.it/Rivista_IEM/2
006_02/11Difficult
%20airway
%20manageme
nt.pdf)
procedura operativa standard
riassunto delle caratteristiche del prodotto
clausola provvisoria
of a marketing
authorisation
sospensione
(same as
denominazione commerciale
invented name)
medicinali vegetali tradizionali
variazione di tipo I
variazione di tipo II
in corso di valutazione
consultazione con gli utilizzatori
prove effettuate con gli utilizzatori
validazione
variazioni alle autorizzazioni all'immissione in
commercio
medicinali veterinari per animali destinati alla
produzione di alimenti
ritiro della domanda di autorizzazione
all'immissione in commercio
tempo di attesa
studio caso-controllo
sperimentazione clinica
studio di coorte
studi osservazionali comparativi
(survey)
studio trasversale
studio sull'utilizzazione del medicinale
metodi epidemiologici per studi sulla sicurezza

successivi all'autorizzazione
buona pratica clinica
buona prassi di laboratorio
buona pratica di fabbricazione
Intensive
programmi di monitoraggio intensivo
monitoring is a
system of
record collation
in designated
areas e.g.
hospital units or
by specific
physicians in
community
practice.
megatrial; studio allargato pragmatico
NBF
metodi di sorveglianza attiva
(study)
insorgenza di una malattia
dati farmacodinamici
analisi farmacocinetiche
effetti della classe farmacologica
Studio di fase III
monitoraggio degli eventi conseguenti alla

prescrizione
siti sentinella
campione
prove di stabilit
processo di controllo dei cambiamenti

denominazione comune
documento tecnico comune
norma di interscambio dati
documento tecnico comune in formato

elettronico
Banca dati europea dei medicinali
Eudraphar
m
eXtensible Markup Language
XML
banca dati sulla sicurezza umana
Light Authoring Tool

sistema di revisione informatica delle
informazioni sul prodotto
gestione delle informazioni sul prodotto
IT Source
http:/emea.europa.eu/pdfs/general/direct/org
anigramme/it
anigramme/it
Regulation (EC) No 726/2004 of the

European Parliament and of the Council of
31 March 2004 laying down Community
procedures for the authorisation and
supervision of medicinal products for human
and veterinary use and establishing a
European Medicines Agency,
CELEX:32004R0726/IT

CELEX:32004R0726/IT

CELEX:32004R0726/IT; D.L.vo 219/06
IT Note

CELEX:32004R0726/IT

anigramme/it
anigramme/it
anigramme/it
anigramme/it
anigramme/it
anigramme/it
anigramme/it
anigramme/it
anigramme/it

anigramme/it
anigramme/it
anigramme/it

anigramme/it
anigramme/it
anigramme/it

anigramme/it

anigramme/it

anigramme/it
anigramme/it

anigramme/it
anigramme/it
anigramme/it
Italian Medicines Agency (EMA NFP)

anigramme/it
anigramme/it
EMA Work Programme (Summary) 2006

Eurordis Newsletter, January 2007
EMA Work Programme 2004



EudraLex, vol. 3A ; Epilex
Directive 2001/83/EC of the European
Parliament and of the Council of 6 November
2001 on the Community code relating to
medicinal products for human use,
CELEX:32001L0083/IT

CELEX:32004R0726/IT


Parliament and of the Council of 4 April 2001
on the approximation of the laws, regulations
and administrative provisions of the Member
States relating to the implementation of good
clinical practice in the conduct of clinical
trials on medicinal products for human use;
EMA Work Programme 1997-1998
CDJ JUDIT Aot 1993

CELEX:32001L0083/IT; Regulation (EC) No
726/2004 of the European Parliament and of
the Council of 31 March 2004 laying down
Community procedures for the authorisation
and supervision of medicinal products for
human and veterinary use and establishing a
CELEX:32004R0726/IT

veterinary medicinal products,
CELEX:32001L0082/IT
EMA Template
Ministero della Sanit: decreto 20 gennaio
1999

CELEX:32001L0083/IT; Regulation (EC) No
726/2004 of the European Parliament and of
the Council of 31 March 2004 laying down
Community procedures for the authorisation
and supervision of medicinal products for
human and veterinary use and establishing a
CELEX:32004R0726/IT
Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the C

CELEX:32004R0726/IT

CELEX:32004R0726/IT

CELEX:32004R0726/IT

CELEX:32004R0726/IT

CELEX:32004R0726/IT

CELEX:32004R0726/IT

EMA Template ; Italian Medicines Agency

(EMA NFP)
CELEX:32004R0726/IT ; Council Regulation
(EEC) No 2377/90 of 26 June 1990 laying
down a Community procedure for the
establishment of maximum residue limits of
veterinary medicinal products in foodstuffs of
animal origin, CELEX:31990R2377/IT
EMA Template
EMA QRD template, URL: http://www.emea.europa.eu/htms/human/qrd/qrdtemplate.htm
Allegato I Riassunto delle caratteristiche del

prodotto (EMA)

prodotto (EMA)
Remicade, INN-Infliximab
Council Regulation (EC) No 297/95 of 10

February 1995 on fees payable to the
European Agency for the Evaluation of
Medicinal Products, CELEX:31995R0297/IT
II Workshop di Farmacovigilanza e Farmacoutilizzazione, URL: http://www.sanita.lombardia.it/pubblicazionivarie/mosan2002/r
Judgment of the Court (Sixth Chamber) of 16

October 2003, Case C-223/01, European
Court reports 2003 Page I-11809,
CELEX:62001J0223/IT ;
CELEX:32001L0082/IT

trials on medicinal products for human use,
Article 11, CELEX:32001L0020/IT

CELEX:32001L0083/IT
Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine, CELEX:3200

trials on medicinal products for human use,
CELEX:32001L0020/IT

Council Regulation (EC) No 297/95 of 10
February 1995 on fees payable to the

prodotto (EMA)
CELEX:32004R0726/IT
COM/2004/0124 final

CELEX:32004R0726/IT

CELEX:32004R0726/IT

CELEX:32004R0726/IT

CELEX:32001L0082/IT ; Council Regulation
(EEC) No 2377/90 of 26 June 1990 laying
down a Community procedure for the
establishment of maximum residue limits of
veterinary medicinal products in foodstuffs of
animal origin, CELEX:31990R2377/IT
Communication from the Commission to the

Council, the European Parliament, the
European Economic and Social Committee
and the Committee of the Regions - e-Health
- making healthcare better for European
citizens: an action plan for a European eHealth Area, CELEX:52004DC0356/IT


CELEX:32004R0726/IT
http://www.farmacovigilanza.org/pediatria/struttura-emea.asp
Opinion of the Commission, COM/2004/0124

final

16 December 1999 on orphan medicinal
products, CELEX:32000R0141/IT
Communication from the Commission Commission Communication on parallel

imports of proprietary medicinal products for
which marketing authorisations have already
been granted, CELEX:52003DC0839/IT
Communication from the Commission Commission Communication on parallel

imports of proprietary medicinal products for
which marketing authorisations have already
been granted, CELEX:52003DC0839/IT

CELEX:32004R0726/IT ; Directive
2001/82/EC of the European Parliament and
of the Council of 6 November 2001 on the
Community code relating to veterinary
medicinal products, CELEX:32001L0082/IT

CELEX:32004R0726/IT
Council Directive of 26 January 1965 on the

approximation of provisions laid down by
law, regulation or administrative action
relating to proprietary medicinal products,
CELEX:31965L0065R/IT
Council Regulation (EEC) No 2309/93 of 22

July 1993 laying down Community
procedures for the authorization and
Agenzia italiana del farmaco
Ministero della salute: decreto 12 dicembre

2003

CELEX:32001L0082/IT
EMA, Domande ricorrenti

June 1990 laying down a Community
procedure for the establishment of maximum
residue limits of veterinary medicinal
products in foodstuffs of animal origin,
CELEX:31990R2377/IT
CdT internal document EMA/405238/2006


CELEX:32004R0726/IT
Regolamento interno CHMP, 2004
Regolamento interno CHMP, 2004

CELEX:32004R0726/IT
Term-IT CdT



CELEX:32004R0726/IT

CELEX:32004R0726/IT
EMA Work Programme 2005 ; Directive

2001/82/EC of the European Parliament and
of the Council of 6 November 2001 on the
Community code relating to veterinary
medicinal products, CELEX:32001L0082/IT

CELEX:32001L0082/IT

Commission Directive 91/412/EEC of 23 July

1991 laying down the principles and
guidelines of good manufacturing practice for
CELEX:31991L0412/IT

EMA Template

CELEX:32004R0726/IT

CELEX:32004R0726/IT
Commission Regulation (EC) No 1084/2003

of 3 June 2003 concerning the examination
of variations to the terms of a marketing
authorisation for medicinal products for
human use and veterinary medicinal
products granted by a competent authority of
a Member State, CELEX:32003R1084/IT

CELEX:32004R0726/IT
(analogo a nome di
fantasia)
EMA Annual Report 2004 ; Epilex

Commission Regulation (EC) No 2049/2005,

CELEX:32005R2049/IT

CELEX:32001L0082/IT
Riassunto delle caratteristiche del prodotto:
ProQuad
Bollettino d'informazione sui farmaci, n.2,

2004
METODI DI FARMACOVIGILANZA, URL: http://www.farmacovigilanza.org/corsi/051130-02.asp
Osservatorio Epidemiologico Metropolitano

Dipendenze Patologiche, URL:
http://www.ossdipbo.org/lavori_in_corso.html

July 1993 laying down Community
procedures for the authorization and

CELEX:32004R0726/IT
Council Directive 2006/88/EC of 24 October

2006 on animal health requirements for
aquaculture animals and products thereof,
and on the prevention and control of certain
diseases in aquatic animals,
CELEX:32006L0088/IT
Council Directive 2006/88/EC of 24 October (studio)

2006 on animal health requirements for
aquaculture animals and products thereof,
and on the prevention and control of certain
diseases in aquatic animals,
CELEX:32006L0088/IT
Commission Directive 2003/63/EC of 25

June 2003 amending Directive 2001/83/EC
of the European Parliament and of the
Council on the Community code relating to
CELEX:32003L0063/IT
Commission Directive 92/18/EEC of 20

March 1992 modifying the Annex to Council
Directive 81/852/EEC on the approximation
of the laws of Member States relating to
analytical, pharmacotoxicological and clinical
standards and protocols in respect of the
texting of veterinary medicinal products,
CELEX:31992L0018/IT
METODI DI FARMACOVIGILANZA, URL:

http://www.farmacovigilanza.org/corsi/05113
0-02.asp

Council Directive 92/27/EEC of 31 March
1992 on the labelling of medicinal products
for human use and on package leaflets,
CELEX:31992L0027/IT
Commission Directive 2003/63/EC of 25

June 2003 amending Directive 2001/83/EC
of the European Parliament and of the
Council on the Community code relating to
CELEX:32003L0063/IT ; D.Lvo n. 219
24.04.2006
Commission Regulation (EC) No 782/2005

of 24 May 2005 setting out the format for the
transmission of results on waste statistics,
CELEX:32005R0782/IT
Term-IT CdT


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EMA organigramme, URL:

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Meeting Management and

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Project Management Sector

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Regulatory Affairs and

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Scientific Advice and

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Central Information Group

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Art. 27-28 of EC Directive

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CVMP Working Party

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International Conference on ICH

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