Crown Pharmaceutical Regulatory Affairs Post Graduate Certificate

http://www.crownacademy.ca
All unauthorized reproduction is prohibited.
Pharmaceutical Regulatory
Affairs in Russia
Professor: Peivand Pirouzi, Ph.D., MBA
2016
Post-Graduate Certificate in Regulatory Affairs and Drug Submission
Crown Medical Research and Pharmaceutical Sciences
College of Canada

Table of Content
• Regulatory overview
• Pricing and state funding
• Manufacturing
• Clinical trials
• Marketing
• Advertising
• Packaging and labelling
• Traditional herbal medicines
• Patents
• Trade marks
• Product liability
• Reform

Russian Federation
- Russia, also officially known as the
Russian Federation, is a country in
northern Eurasia.
- It has been reconstituted of Russian
Soviet Federative Socialist Republic of
Soviet Union after the dissolution of the
Soviet Union in 1991.
- It is a federal semi-presidential republic.
At 17,075,400 square kilometers, Russia
is the largest country in the world,
covering more than one-eighth of the
Earth's inhabited land area.
- Russia is also the world's ninth most
populous nation with nearly 144 million
people as of 2015.
- Semi-presidentialism is a system of government, in which a
president exists along with a prime minister and the Cabinet,
with the latter two being responsible to the legislature of a state
(A state is an organized community living under one
government)
• Flag and coat of
arms

Ministry of Health of the Russian Federation
• The Ministry of Health of
the Russian Federation is
an agency of the
government of Russia.
• Formed in 2012
• Preceding Agency:
Ministry of Health and
Social Development
• Headquarters, in Moscow
• Website:
www.rosminzdrav.ru
• Coat of Arms

Duties of Ministry of Health
Its main official responsibilities include:
• Developing and implementing state policy in healthcare;
• Developing and implementing federal health programs, including initiatives on
diabetes, tuberculosis, health promotion, health education, disease prevention etc.;
• Developing draft legislation and presenting it to the State Duma[which is the lower
house of the Federal Assembly of Russia (legislature), the upper house being the
Federation Council of Russia]
• Governance of federal medical facilities;
• Medical education and manpower development;
• Epidemiological and environmental health monitoring and health statistics;
• Control of infectious diseases;
• Development of health regulations;
• Development of federal standards and recommendations for quality assurance;
• Development and implementation of federal health programs
• Control and licensing of drugs.

Regulatory overview
Legislation of the Russian Federation
The Regulatory bodies governing the pharmaceutical markets are The Ministry of Healthcare and Social Development (the MOH),
the Ministry of Industry and Trade (the “MIT”) and the Federal Service for Surveillance in Healthcare and Social
Development (the Federal Service)
MOH is responsible for drawing up state policy and regulation in Healthcare and social development.
MOH submits to the government drafts of Federal Constitutional Law, Federal Law , Acts of President and government in the
Healthcare, including on the organization of medical assistance related to pharmaceutical activities, and the quality, efficacy
and safety of medicines.
- Fundamentals of the legislation of the Russian Federation on
Citizen’s Health Protection No. 5487-1, dated 22 July 1993
- Federal Law 86-FZ on Medicines, dated 22 June 1998
- Federal Law 184-FZ on Technical Regulation dated 27 December
- Federal Law 38-FZ on Advertising, dated 13 March 2006
- Federal Law 38-FZ on Licensing of Certain Types of Activities,
dated 8 August 2001

Pricing and state funding
structure and funding of the national healthcare
system:
• It is state organized and state funded,
• Private healthcare sector is also developing
• Employers pay for their employees to the Federal Fund
of Mandatory Medical insurance (FFOMS),
• Certain employers obtain voluntary medical insurance to
supplement the minimum healthcare guaranteed by the
state.

circumstances for regulating prices of medicinal
products:
• Resolution 782, on State Control of the Prices of Medicines,
dated 9 Nov. 2001
• EDL is stablished by Government Ordinance 376-r dated 29
March 2007, and price of EDL is controlled by State through
registration of Max. prices and Max. mark-ups
• Government Decree 239 on Measures for Arranging the
State Regulation of Prices (Tarrifs), dated 7 March 1995,
other medicines prices & mark-ups are regulated on a
regional level.
Mark-up: A percentage or amount added to the cost of a commodity (medicine) to provide the seller with a profit and to
cover overheads, costs,etc.

Timing and the procedure and pricing for state
funding or reimbursement:
• State bodies purchase necessary medicines and distribute it freely to qualifying
citizens (patients)
• DLO (Provision of Supplemental Medicines) or ONLS (Essential Drug Program)
program: Certain categories of citizens(social security beneficiaries) receive certain
medicines free of charge. Purchase of medicines in ONLS are organized through
auctions at a regional level.
• MOH Order 655, dated 18 Sep 2006 approves the current list of medicines included
in ONLS program.
• Expensive medicines for treatment of certain diseases (formerly part of ONLS
program) is organized at the federal level and these medicines are purchased
through auctions which are conducted by MOH.
• Government Resolution 2053-r dated 31 Dec. 2008 stablishes the current list of
expensive medicines.
• Federal Law 94-FZ, dated 21 July 2005: Purchases of medicines in these programs
and other purchases of medicines for state or municipal needs under other programs
are carried out according to this Federal Law.
• The price of the medicines being purchased is determined at auction.

ManufacturingApplication:
• The manufacturing of medicines is subject to licensing.
• An application must be made to the Federal Services
conditions to obtain authorization :
• Government Resolution 415 dated 6 July 2006 states the regulation on the licensing the manufacturing of
Medicines and stablishes the following requirements:
1) The Licensee must either own premises and equipment or has the right to use qualifying premises and equipment
of other manufacturers
2) The licensee must comply with the rules for organizing manufacturing and quality control
3) The licensee must have legal ground for manufacturing patented and/or original medicines
4) The licensee must comply with prohibitions on selling disqualified medicines and requirements for destroying such
medicines.

Manufacturing
5) The licensee should have specialized secondary education staff responsible for manufacturing, quality and labelling
of medicines, with at least 3 years experience.
6) The licensee’s staff must undergo professional training at least every five years.
Restrictions on foreign applicants
To manufacture medicines in Russia: Russian law does not directly prohibit foreign legal entities to apply for the
license of manufacturing the medicines. However, an application to apply for the license requires OGRN and certificate
on state registration which both can only be issued to a Russian legal entity.
To import medicines into Russia: Under Russian customs law, an importer must be either a Russian legal entity or a
registered entrepreneur in Russia with a direct contract with the foreign supplier and/or a Russian licensed customs
broker. Therefore, if a manufacturer intends to directly import medicines into Russia, a Russian subsidiary of a foreign
legal entity applies for a manufacturing and importing license.
OGRN – Major State Registration Number of the entry made in the Register about formation of a Russian company
(consists of 12 digits).A subsidiary established in Russia is a Russian company where a majority of capital or shares
with voting rights are owned by a foreign legal entity. The liability of the shareholders of this type of business is limited
by the contribution to the capital. The two forms of business that can be established in Russia are the private limited
liability companies or the public limited liability companies, open or closed.

Manufacturing
Key stages and timing: Law of Licensing: when a complete application is submitted to
the Federal Service, within 45 days, the Federal service must decide whether to issue a
license and/or notify the applicant about the decision. Then the applicant produces a
document confirming payment of the license fee, and within three days the Federal
Service must issue the license.
Fee :The license filing fee is RUB300 (about US$10), and license issuance fee
isRUB1,000(about US$33)
Period of authorization and renewals: The license is issued for 5 year but it can be
extended for another five years, the licensee must file application within ten days to the
Federal Service.
The powers of regulator: The Russian state facilities monitor compliance with the
license terms and conditions by visiting the facilities of the manufacturer, and if it does
not comply it can be subject to administrative fines and ultimately the license can be
annulled through a court decision. In certain cases it might lead to criminal liability for the
management of the company.

Clinical trials
Clinical Trials are governed by the Fundamentals, MOH Order 266 dated 19 June 2003 which is about
the Law on Medicines, and the Rules of Clinical Practice in Russia, and also law on circulation of
medicines.
The relevant documents from ICH-GCP :
• Industry Standard OST 42-511-99 - Good Clinical Practice, adopted by the Russian Ministry of
Healthcare on 29 December 1998,
• National Standard of the Russian Federation GOST R 52379-2005 - Good Clinical Practice,
adopted by Order of the Federal Agency on Technical Regulation and Metrology No. 232-st, dated
27 September 2005.
Both documents are derived from the Good Clinical Practice guidelines (GCP) of the International
Conference on Harmonization (ICH), the latter document being a direct translation.
• fundamental law: (Law) the law determining the constitution of the government of a state

Clinical trials
Requirements:
• A permit from the Federal Service to perform clinical trials
• The consent of the Ethical Committee organized by the Federal Service
• Informed consent from all trial subjects before participation in the trial
• After the trial, a report of the trial must be prepared and filed with the
Federal Services
Conditions for each trial that should be met:
• Written agreement with duly accredited trial sites
• Insurance of the health of patients
• Civil liability of persons and entities performing trials

Marketing
Application
• Medicines are subject to obligatory state registration before their introduction into and
circulation in the Russian market.
• An application for state registration of a medicine must be made to the Federal
Service.
Conditions to obtain authorization
• For registration, each medicine must pass expert examination and clinical trials
providing its efficacy, safety and quality.
• The necessary documents must be filed with the application to the Federal Service.
• Marketing of medicine is subject to declaration of conformity and other state controls,
during which compliance of the medicine with the normative documentation approved
during its state registration is checked.

Marketing
Key stages and timing
• The procedure for state registration of a medicine should generally
be completed within six months from the submission of a complete
application dossier.
Fee
• The fee for state registration of a medicine is RUB2,000 (about
US$67)(Tax Code).
• The expert examinations and clinical trials necessary for the process
of registration of a medicine are a separate, and much higher,
expense.

Marketing
• The registration of a medicine generally lasts for an
indefinite term.
• Foreign marketing authorizations is not recognized in
Russian jurisdiction.

Marketing- Abridged procedure
Which products can benefit from the abridged
procedure?
• Differences only in the composition of excipients and
manufacturing technology
• No effect on efficacy, quality and safety of the medicine
Duration of expedited registration procedure ?
• Within 3 months from submission of a complete application
dossier
• References to open literature and a bioequivalence study
report

Marketing
What powers does the regulator have to monitor
compliance with marketing authorization or impose
penalties for a breach of a marketing authorization?
• Release of a medicine in consumer packaging into the
Russian market is preceded by a declaration of its
conformity by checking the compliance of the medicine with
the normative documentation approved during its state
registration.

Marketing
Additional forms of state control :
• Preliminary state control 3 sample industrial batches of
medicines imported into or manufactured in Russia for the first
time , before any commercial circulation of the product
• Selective state control according to schedules drawn up by
the Federal Service relating to the safety of medicines on
the market
• Recurrent selective state control doubt in the quality of
medicines on application to the Federal Service

Marketing
Non-compliance of medicines with their normative
documentation approved :
• During state registration the declaration of conformity is not
registered and medicine can not be released to market
• After being released to market recalling the relevant
batches from the market
• Medicine of poor quality treated as a violation of the
manufacturer’s license

Marketing
parallel imports of medicinal products into Russian jurisdiction :
• No restriction , however , importation of goods bearing trade marks
into Russia without authorization from rights holder is generally
prohibited under Russian trade mark law.
Restrictions on marketing practices such as gifts or "incentive
schemes" for healthcare establishments or individual medical
practitioners:
• Any gifts made for marketing purposes are subject to general rules
of Russian law.
• Civil Code prohibits gifts between commercial legal entities.
• Undue gifts may cause administrative and criminal liability for
bribery or commercial bribery.

Marketing
Restrictions on marketing medicinal products on the
internet, by e-mail and by mail order :
• These activities are regulated and restricted if they qualify as
advertising.
• Internet advertising subject to general rules on advertising
• Email advertising prior consent of the addressee required
additionally
• Mail advertising  specific rules were abolished in Russia at
the end of 2008. Only subject to the general rules on
advertising

Advertising of Medicines
Which legislation applies and which regulatory
authority enforces it?
• Governed by the law on advertising. The Federal
Antimonopoly Service is the regulatory authority.
What types of medicinal product can be advertised?
• Only registered medicines
• Prescription medicines and medicines that contain narcotic or
psychotropic substances approved for medical use only when
advertised in specialized printed publications intended for
medical and pharmaceutical professionals

Advertising
What restrictions apply to advertising that is allowed?
• Advertising must be fair and true
• advertisement of medicines must be accompanied by a
warning about contraindications against their use and
application
• the necessity to read the instructions on their use or the
necessity to consult a specialist
The Law on Advertising contains an important
general prohibition against using images of medical
and pharmaceutical professionals in any adverts.

Packaging and labelling of
Medicines
Which legislation applies and which regulatory
authority enforces it?
• Governed by the Law on Medicines. The Federal Service
enforces the relevant regulations.
• The main requirements for labelling medicines are set out in
Article 16 of the Law on Medicines.
• All the information must be stated in Russian

Packaging and labelling
What information must the packaging and/or labelling
contain?
• Trade and international non-proprietary names of the medicine.
• Name of the manufacturer of the medicine.
• Batch number and manufacturing date.
• Method of administration.
• Dosage and quantity of doses in a package.
• Shelf life.
• Conditions of sale.
• Conditions of storage.
• Precautionary measures in administration of the medicine.

Traditional herbal medicines
The regulation of the manufacture and marketing of
traditional herbal medicinal products in Russian
jurisdiction is the same as the regulation for other
medicines.

Patents
• An invention is a technical solution in any field that relates to a
product (including a device, substance, strain of microorganisms,
plant or animal cell culture) or a method (the process of carrying out
actions relating to a material object by material means).
• To obtain patent protection an invention must be novel, inventive
(non-obvious) and industrially applicable
Which legislation applies to obtain patent protection
for an invention in Russia?
• The national patent system (by applying to the Federal Service for
Intellectual Property, Patents and Trade marks) (Rospatent)
(Russian Patent Office).
• The regional Eurasian patent system (by applying to the Eurasian
Patent Office).

Patents
• Eurasian regional patent system is similar to the European patent
system.
• Under the Eurasian patent system, one application and one patent
covers nine jurisdictions in the CIS region (the contracting states).

Patents
What types of medicinal products and related substances and
processes can be protected by patents?
• Methods/processes for treatment, diagnosis and prevention of
diseases
What types cannot be patent protected?
• Human cloning techniques
• Techniques for modifying the genetic integrity of human embryo
cells.
• Use of human embryos for industrial and commercial purposes.
• Other solutions inconsistent with the public interest and humane and
moral principles.

Patents
To which authority must the application be made?
• Applications for Russian patents must be filed with the
Russian Patent Office. Applications for Eurasian patents are
filed with the Eurasian Patent Office. Both offices are in
Moscow.

PatentsFees
• Russian Patent Office fees are:
• RUB5,400 (about US$190) for filing an application, plus RUB810 (about US$28) for
each claim exceeding 25 claims.
• RUB8,100 (about US$285) for filing a request for substantive examination of one
independent claim. This fee is reduced by 20% for applications with international
reports.
• RUB10,800 (about US$380) for issue and registration.
• Eurasian Patent Office fees are:
• RUB25,500 (about US$900) for filing an application, plus RUB2,200 (about US$77)
for each claim exceeding five claims. These fees are reduced by 25% for applications
with international reports.
• RUB25,500 (about US$900) for filing a request for substantive examination of one
independent claim, and RUB44,500 (about US$1,560) for two or more independent
claims.

Patents
What are the key stages and timing?
Russian Patent Office procedure granted in 1.5-3 years from
filing an application, if there are no complications. Two main
stages: formal examination and substantive examination.
Eurasian Patent Office procedures can be granted in 1 year
from the filing date if there are no complications, or up to 2 years
if any issue arises during the application's examination.
Foreign applications may be extended to Russia under the
Patent Cooperation Treaty. This takes 31 months.

Patents
How long does patent protection last?
• Both Russian and Eurasian patents last for a term of 20 years
from the application filing date, subject to due payment of
annual fees.
If a patent covers an invention related to pharmaceuticals,
pesticides or agrochemicals requiring specific authorization, in
certain circumstances the patent term can be extended for up
to five years.
How is a patent renewed or patent protection
extended?
• To keep a patent valid, it is necessary to pay annual
maintenance fees.

Patents
In what circumstances can a patent be revoked?
• Failure to meet patentability requirements.
• Granted claims contain features that were absent in the
application as filed.
The invalidation action must be filed with the
Chamber for Patent Disputes of the Russian Patent
Office.

Patents
When is a patent infringed?
• The scope of the legal protection conferred by a patent is determined
by the granted claims.
• A patented invention is deemed to be used in a product/method if the
product/method contains each feature of the invention covered by an
independent claim of the invention, or a feature equivalent to it and
having become known in this art before performance of actions that
are a use of the patented product/method.
• Any person or legal entity using a patented invention without the
consent of the patent owner is considered to be a patent infringer.
• A product obtained directly by a patented method/process also
infringes the exclusive rights of the patent owner.

Patents
• By law, Russian courts must treat Russian patents and the
Russian part of Eurasian patents in the same manner.
• A patent owner has an exclusive right to use and allow the
use of the patented invention.
• Third parties are prohibited from using the invention without
the patent owner's permission, except for specific cases such
as for experimental and non-commercial purposes that, by
law, do not infringe the patent owner's exclusive right.

Patents
what remedies are available for patent infringement?
The exclusive rights in a patented invention can be protected,
among others, in civil proceedings by means of:
• Recognition of the right.
• Cessation of the infringing actions or actions that create a
threat of infringement.
• Compensation for damage.
• Publication of a court decision on the committed infringement.
Apart from civil liability, a patent infringement can involve
administrative and criminal liability.

Trade marks
• A trade mark is a designation that individualizes the goods or services of legal entities
or individual entrepreneurs.
• A name/brand of a medicinal product can be registered as a trade mark, provided
that it complies with the trade mark registerability criteria.
• The scope of granted protection is limited to the registered designation only and does
not extend to the generic name
a trade mark must:
• Possess sufficient distinctive character.
• Not be contrary to the public interest or accepted principles of morality.
• Not be misleading with respect to the origin of the relevant goods and services.
• Not be similar to earlier trade marks, company names, commercial designations and
so on.

Trade marks
The authority
• Russian trade mark applications must be filed with the Russian
Patent Office
Fee
The Russian Patent Office fees are:
• RUB10,500 (about US$361) for filing an application for a trade mark
in one class, plus RUB1,500 (about US$51) for each additional
class.
• RUB12,000 (about US$412) for registration of a trade mark.

Trade marksProcess and timing:
• After a trade mark application is filed it undergoes formal examination , If
there are no complications , It usually takes about 14 to 16 months from the
filing date to obtain a trade mark registration certificate.
• Russian trade marks are registered for an initial ten-year period.
Registrations can be renewed for an unlimited number of subsequent ten-
year terms, subject to payment of a renewal fee.
• A trade mark can be revoked if it is not continuously used for any 3 year
period after its registration
• A registered trade mark is deemed infringed if an unauthorized person uses
an identical or confusingly similar mark for identical or similar goods or
services, and such use may result in a possibility of confusion.

Patents and Trademarks
Russia is party to, among others, the following international
conventions on patent and trade mark protection:
• Paris Convention for the Protection of Industrial Property 1883 (Paris
Convention).
• Patent Cooperation Treaty 1970.
• Trademark Law Treaty 1994.
• Madrid Agreement Concerning the International Registration of Marks 1891
(Madrid Agreement).
• Protocol Relating to the Madrid Agreement 1989.
• Nice Agreement Concerning the International Classification of Goods and
Services for the Purposes of the Registration of Marks 1957.
• Nairobi Treaty on the Protection of the Olympic Symbol 1981.
• Singapore Treaty on the Law of Trademarks 2006 (entry into force for
Russia on 18 December 2009).

Product liability
Legal provisions
Civil liability in Russia for damage to health or death of patients caused by
medicines is established by:
• The Civil Code.
• The Fundamentals.
• Federal Law 2300-1 On Consumer Rights Protection dated 7 February
1992, as amended (Consumer Protection Law).
• The Law on Medicines.
Substantive test
Under the Civil Code, the substantive test for product liability in the context of
medicines consists of three elements:
• Damage to health or death of a patient.
• Defective medicine.
• Causal link between the defect and the damage caused.

Liability
• Compensation for injury is only recoverable if the injury occurred
before the expiration date of the medicine (Article 1097, Civil Code).
However ,liability may still arise even after the expiration date.
• Article 208 of the Civil Code further provides that claims for
compensation for damage to health or for death caused to a person
are not limited by time.
• Article 1098 of the Civil Code shifts the burden of proof to the
manufacturer, which is released from liability if it proves that the
injury was caused by a force majeure circumstance, or a violation by
the consumer of the rules for storage and use of the medicine.

Liability
• Courts can order the party responsible for injury to compensate the
injured party by providing appropriate goods (compensate in kind) or
pay for losses (Article 1082, Civil Code). Damage to health or death
can only be compensated through financial compensation
• losses include real damages and lost profits
• Russian law does not use the concept of class actions as applied to
product liability claims. A concept similar to class actions was
recently introduced into the Code of Arbitrazh Procedure, which
governs procedures in State Arbitrazh (Commercial) Courts.
However, product liability disputes with consumers fall under the
jurisdiction of the Courts of General Jurisdiction

Reform
• Russian regulation of the pharmaceuticals market is about to
undergo important changes.
• The principal change will be the new Federal Law on Circulation of
Medicines, which purports to replace the Law on Medicines.
• Russian pharmaceuticals market has developed significantly over
the last ten years. Therefore, serious revisions are necessary.

THE REGULATORY AUTHORITIES
MINISTERY OF HEALTHCARE OF SOCIAL DELELOPMENT (MOH ):
• The MOH is responsible for drawing up state policy and regulation in
healthcare and social development. The MOH submits to the Government
drafts of federal laws, acts of the President and the Government in
healthcare, including on the organization of medical assistance related to
pharmaceutical activity, and the quality, efficacy and safety of medicines.
FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE AND SOCIAL
DEVELOPMENT:
• The Federal Service, among other things:
• Grants licenses for manufacturing medicines and pharmaceutical activities
(retail sale, wholesale of medicines and preparation of medicines).
• Keeps a register of licenses granted.
• Exercises state control in the sphere of circulation of medicines.
• Registers medicines and conducts accreditation.

Reference
• www.rosminzdrav.ru

Crown Pharmaceutical Regulatory Affairs Post Graduate Certificate

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