Professional Documents
Culture Documents
Kyiv 2010
Threats
Possibilities
replace of import;
low number of enterprises with GMP certification;
few preparations, combinations and forms of medication presentations on the market;
perspective of insurance system implementation;
export of products to CIS and EU countries;
easy entry to medication distribution market;
placement of generic business;
allocation of pharmaceutical manufacturing on the territory of Ukraine.
LLC
RepOffice
Joining of the State drug quality control inspection to the Pharmaceutical Inspection
Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S):
The final stage for joining of the State drug quality control inspection audit of the regulatory
authority on site in March 2010 has been passed successfully.
Development of a
medicinal product
Clinical trials
Manufacturing
Wholesale
Pre-clinical trials
Registration
Promotion
Utilization
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Registration of IP rights
Import
Retail
Pre-clinical trials
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Clinical trials
Peculiarities of clinical trials in Ukraine
goal to determine the efficacy and safety of a medicinal product;
specialized prevention and treatment facilities having a license and accreditation certificate;
contractual basis;
Manufacturer and Client under clinical trial agreement may not be the same;
patients consent;
elaboration of liability insurance agreements;
adherence to international ethical principles;
adherence to GCP requirements;
conclusion of the State Pharmaceutical Centre of the Ministry of Health of Ukraine (not more
than 60 days, longer for gene therapy);
approval of the Central Ethics Commission;
tax aspects;
peculiarities of personal data usage in the light of the Law of Ukraine On Personal Data
Protection .
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Pricing
Resolution of the Cabinet of Ministers of Ukraine N 955 dd. October 17, 2008
Subject to state control are mark ups for medicinal products and medical devices:
Limited sale
(retail) mark ups
12% wholesale
price
25 purchase
price
10% wholesale
price
10% purchase
price
Medicinal products of domestic manufacturing, wholesale price of which is less than 12 UAH for
package are no subject to state regulations, except those purchased for budget funds.
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Medical equipment and medical devices - devices, complexes, sets, instruments, accessories
materials or other products, which are used for:
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registration: submitting of application + document package for registration with the State
Inspection of Drug Quality Control of the Ministry of Healthcare of Ukraine
term for examination of documents > 90 days;
conducting of expertise and trials by expert institutions, elaboration of a conclusion;
expertises volume depends on the level of potential risk from usage of a medical device in
medical practice;
safety class of medical devices is declared by an applicant and shall be confirmed by results
of technical expertise;
making the decision by the State Inspection of Drug Quality Control of the Ministry of
Healthcare of Ukraine on registration or refusal in registration based on results of expert
examination;
inclusion to the State Register of Medical Equipment and Medical Devices
registration validity term 5 years;
application for re-registration 120 calendar days and 90 calendar days till expiration of
registration validity term;
re-registration in accordance with procedure stipulated for registration.
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Curative cosmetics
Curative cosmetics in form of: cream, milk, oil, mask, gel, emulsion, powder, jelly, balm, lotion,
shampoo, lipstick, pen, salt, bath extract, antiperspirant, depilatory, tooth paste, elixir, sun
bock, insect repellent, soap etc.
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Unfair competition - 1
Antitrust regulation field
coordinated action;
monopoly abuse;
anticompetitive actions of state and local self-government authorities, administrative and
control bodies;
limiting and discriminating activity;
merger control.
Liability:
penalties/confiscation of income (proceeds);
indemnification;
forced demerger.
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Unfair competition - 2
Mechanisms of unfair competition:
use of a medicinal products name of another manufacturer;
use of a medicinal product of another manufacturer;
copying of appearance of products of another manufacturer of medicinal products;
comparative advertisement;
discrediting of a business entity;
forcing to boycott a business entity;
forcing suppliers to discredit buyers;
bribing of employees, officers of supplier;
collection, disclosure or forcing to disclosure, illegal use of commercial secrets;
distribution of misleading information.
Protection:
- penalty;
- product recall;
- indemnification;
- official contradiction of information.
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State procurement
Law of Ukraine On State Purchases dated 01.06.2010 No. 2289
- possibility of participation in state procurements procedure on parity basis for domestic and
foreign participants;
- in case of urgent necessity possibility to purchase medicinal products under shortened
procedure (term of such applications for competitive procurement can be reduced up to 15 days);
- appeal authority Antimonopoly Committee of Ukraine
Manufacturer-nonresident
Ministry of
Health
Representatives,
dealers, distributors
of the manufacturer
Medical
institutions
Manufacturers
residents
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Arzinger services
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Arzinger services
Antimonopoly regulation
Protection against coordinated actions;
Protection against monopoly abuse;
Protection against limiting and
discriminating actions of competitors and
other business entities;
Concentration or coordinated actions
permits;
Appeal against decisions of authorities in
judicial and administrative proceedings;
Legal support by initiation of proceedings
on violation of legislation on protection of
competition;
Cooperation with regulatory authorities
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Arzinger services
Preclinical and clinical trials
Elaboration of agreements between Client
and Contractor on medication preclinical
study;
Elaboration of agreements on medication
clinical trials;
Legal consulting as to researcher or
sponsor liability, elaboration of third party
liability agreements;
Legal consulting as to patients consent;
Consulting on taxation of clinical trials;
Cooperation with regulatory authorities.
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Arzinger services
Import of medicinal products
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License obtaining;
Support by customs clearance, obtaining
of a permit for single-case import of
unregistered medicinal products by the
Ministry of Healthcare of Ukraine,
obtaining of a letter for import of
unregistered medicinal products for
preclinical study, clinical trial and state
registration purposes in the State
Pharmacological Centre;
Support by obtaining of certificates for
import into and export from Ukraine of
narcotics, psychotropic substances and
precursors in the Narcotics control
Committee of the Ministry of Health;
Arzinger services
Manufacturing of medicinal products
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License obtaining;
Consulting as to manufacturing
(production) of medicinal products in
pharmacies;
Support by obtaining and recognition of
GMP certificate;
Consulting as to norms and requirements
of the State Pharmacopeia of Ukraine;
Control over legality of scheduled and
unscheduled inspections regarding
adherence to GMP requirements by the
State Inspection of Drug Quality Control
of the Ministry of Healthcare in Ukraine;
Arzinger services
Sale of medicinal products
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Tenders/state procurement;
Legal consulting as to marketing activity
in the pharmaceutical sector;
Legal consulting as to advertisement in the
pharmaceutical sphere;
Consulting on employment issues,
delivery contracts, court representation,
tax issues;
Legal consulting as to liability distribution
for low quality medicinal products
between a manufacturer, an importer and a
seller;
Examination of eligibility of state control
over wholesale and retail;
Arzinger services
Wholesale
Support by obtaining of a license or patent
for medicinal products wholesale;
Approval of a pharmacy warehouse
passport, including obtaining of a report
on existing premises and equipment of a
pharmacy warehouse;
Consulting on incoming control over
quality of medicinal products in
pharmacies, in particular:
Execution of an incoming control report;
Records keeping on received medicinal
products;
Records keeping on medicinal products
being sold.
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Retail
Support by obtaining of a license or patent
for medicinal products retail;
Approval of a pharmacy passport;
State accreditation of pharmacies;
elaboration of internal documents;
Consulting as to form of sale of medicinal
products and medical devices in
pharmacies and their structural
subdivisions, incoming control;
Legal consulting on receipt and storage of
medicinal products.
Arzinger services
Utilization and disposal of medicinal products
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Contact information
It will be an honor for us to be your long-term partner in the field of PPP!
Kyiv Office
Business Centre ''Eurasia'
75 Zhylyanska st., 5th Floor, 01032 Kyiv, Ukraine
Tel: +38 (044) 390 55 33
Fax. +38 (044) 390 55 40
Lviv Office
6, Generala Chuprynky st., office 1, 79013, Lviv, Ukraine
Tel: +38 032 242 96 96
Fax: +38 032 242 96 95
Odesa Office
33, Zhukovskogo street, office 601, 6th floor, 65045, Odesa, Ukraine
Tel: +38 048 711 74 74
Fax: +38 048 711 74 74
Key contacts:
Timur Bondaryev, senior partner: Timur.Bondaryev@arzinger.ua
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