Marketing, Manufacturing, Packaging & Labeling, Advertising
Learn more about marketing, manufacturing, packaging & labeling, and advertising in Russian pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications has been already covered by Question 3 in Regulatory, Pricing, and Reimbursement Overview.
In addition, biomedical cellular products (“BCP”), i.e. products containing cultivated living cells of human, used in various studies and in medicine, can be classified as “other medicinal products”.
BCP authorization process includes obligatory receiving of marketing authorization. BCP manufacturers can only distribute them to:
- other BCP manufacturers for BCP manufacturing;
- scientific organizations, education organizations for carrying out scientific
- healthcare organizations.
2. What is the authorization process for the marketing of generic versions of these products?
As already mentioned in Question 3 of Regulatory, Pricing, and Reimbursement Overview, authorization of generic products is allowed only after 4 years from the original drug’s registration.
The authorization process is similar to authorization of original drug, more simplified though. In particular, no personal preclinical and clinical trials are required from the applicant, bioequivalence trials are required instead.
Besides, accelerated authorization procedure (which includes shortened timelines) is available to original drug’s first three generic products.
3. What are the typical fees for marketing approval?
The government fees for marketing authorization issuance are the following:
- for a drug: USD 165 (RUB 10 000);
- for a medical device: USD 115 (RUB 7 000);
- for a BCP: USD 80 (RUB 5 000).
Besides, additional fees are incurred before the registration process with governmental authorities (e.g. production fees, expert examination fees, etc.)
4. What is the period of authorization and the renewal process?
Drugs: the first marketing authorization for a newly registered drug is issued for a period of 5 years. Upon the marketing authorization’s expiration, the renewal process is required, upon which marketing authorization is granted for unlimited period of time.
Medical devices: marketing authorization is granted for unlimited period of time.
BCP: the first marketing authorization is issued for 5 years. Upon the marketing authorization’s expiration, the marketing authorization must be renewed each 5 years (number of renewals is unlimited).
5. What are the requirements, if any, for post-approval pharmacovigilance?
Each marketing authorization holder must carry out the reception, accounting, processing, analysis and storage of all notifications received about side effects, adverse reactions, serious adverse reactions (including unexpected) with the use of drugs or medical devices, about the individual intolerance, lack of efficacy of medicinal products, as well as about other facts and circumstances that represent a threat to the life or health of a human with the use of drugs. All such notifications must be reported to state authorities.
6. Are foreign marketing authorizations recognized?
Foreign marketing authorizations are not valid in Russia.
7. Are parallel imports of medicines or devices allowed?
Until 2018 parallel imports of goods was treated similarly to import of counterfeit products and hence prohibited in Russia. Any trademarked goods could be brought into circulation within Russia or members of the Eurasian Economic Union only by trademark holder or with their consent.
In the early 2018, the Constitutional Court checked validity of the regime of parallel imports and related legal remedies. The Constitutional Court recognized the provisions of the Russian Civil Code valid and complied with Constitution. However, the Constitutional Court restricted IP holders’ authority to control importation of goods into Russia and in fact legalized parallel imports of goods.
According to the Constitutional Court’s approach:
- the court may dismiss the claim of the trademark holder wholly or in part, reduce the amount of compensation if the holder acts in bad faith, i.e. restricts the import of particular goods into the territory of Russia, which results in selling goods at inflated prices;
- the court may not impose the same civil liability on importers of original products and importer of counterfeit products.
- parallel imported original goods cannot be confiscated and destroyed, if only such goods bring inadequate quality or pose risk of negative influence to human health, nature preservation or cultural values.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
Healthcare practitioners are not allowed to:
- accept gifts, cash, including payment for entertainment, recreation, travel to the place of rest, as well as participate in sponsored entertainment events;
- enter into an agreement on the appointment or recommendation of drugs, medical devices to patients;
- receive samples of drugs, medical devices for further delivery to patients;
- have appointments with representatives of organizations engaged in the development, production and (or) sale of drugs, medical products that have rights to the trade name of the drugs;
- issue prescriptions for medicinal drugs, medical devices on forms that contain advertising information.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
Law on Circulation of Drugs is the main statute regulating ground principles of drugs’ manufacturing. As for the manufacturing of medical devices, some basic grounds are established by Law on fundamental healthcare principles, more specific requirements are enumerated in “Rules of State Registration of Medical Devices” approved by Regulation of the Government of the Russian Federation dd 27.12.2012 No. 1416.
Minzdrav is a governmental body responsible for enforcing the regulatory framework in relation to drugs and medical devices.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
Provisions of Russian GMP analogue (“Rules of organization and inspection of drugs’ manufacturers for compliance with the requirements of good manufacturing practice, as well as the issuance of conclusions on drugs manufacturer’s compliance to these requirements” approved by Resolution of the Government of the Russian Federation dd 03.12.2015 No. 1314) are similar to GMPs as defined by the U.S. Food & Drug Administration and / or the European Medicines Agency and include a lot of their adapted provisions. However, not all provisions are identical.
11. What is the inspection regime for manufacturing facilities?
Manufacturing facilities can be inspected within licensing supervision measures on both scheduled and unscheduled basis. State authority responsible for such inspections is:
- for medical drugs: Russian Ministry of Industry and Trade and its subordinated authorities;
- for veterinary drugs: Federal Service for Veterinary and Phytosanitary Surveillance and its subordinated authorities;
- for medical devices: Minzdrav.
All inspections are aimed at ensuring the manufacturer’s compliance with the requirements of laws and Russian GMPs as for the manufacturing process management and quality control. Negative results of such inspections can entail revocation of the marketing authorization.
In addition, each manufacturer is responsible for conducting self-inspections as well.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Manufacturing facilities can be examined by foreign inspectors or third-party inspectors only within self-inspection conducted by manufacturer. Such inspections can involve independent inspectors as well. In other cases, inspections are to be held by employees of the relevant authorized authority with a special knowledge and period of service.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The drugs storage rules establish the basic requirements for the premises, equipment, as well as the storage management of drugs. Requirements are classified in accordance with the composition and characteristics of drugs: there are requirements for flammable and explosive drugs, drugs that require protection against sunlight, moisture, evaporation, thermal effect, gases, etc. Besides, drugs are also placed indoors considering the requirements that are specified on the package.
Certain requirements are stipulated for medical devices storage depending on the material they are made of. Moreover, for each type of product specific requirements are set as for the premise where the product is stored (e.g. sunlight protection, temperature conditions), the order of products’ placement in storage (chronological, alphabetical). Besides, special conditions are envisaged for some types of products.
Requirements for packaging are covered by Questions 14-15 of this Chapter.
14. What information must be included in medicine and device labeling?
Drug labeling must include essentially the following information on the secondary (consumer) package:
- medicinal product name (INN or generic name, or chemical and brand name);
- manufacturer’s name;
- batch number;
- marketing authorization number;
- best before date;
- drug route;
- dosage or concentration;
- strength measured in units of activity or dose number per package;
- pharmaceutical form;
- prescription status;
- storage requirements;
- cautionary warning;
- bar code.
The general rule is that labeling information must be in Russian and easy to read.
Additional requirements may be established for specific type of drug: e.g. for homeopathic drug information “homeopathic” must be included as well; for drugs to be used in clinical trials information “to be used in clinical trials” must be additionally set forth.
15. What additional information may be included in labeling and packaging?
Additional information may be included in secondary (consumer) package given its compliance with the drug’s registration dossier.
Besides, at this moment it is possible to put additional two-dimensional bar code on a secondary drug labeling, which makes possible to monitor drug’s movement from manufacturer to end-consumer. However, starting from January 01, 2020 this requirement will become obligatory.
16. What items may not be included in labeling and packaging?
Russian laws establish only list of mandatory information to be included in labeling. There is no information regarding list of prohibited information.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Firstly, activities on the production of drugs as well as pharmaceutical activities are licensed (Art. 12 of the Federal Law “On licensing of certain types of activities”).
Secondly, state regulation of prices for drugs is carried out in the Russian Federation. Manufacturers set the maximum selling price on drugs from EDL (please refer to Question 12 in Regulatory, Pricing, and Reimbursement Overview Section) in accordance with the methodology established by the Government of the Russian Federation. Further the maximum selling price is subject to registration. The executive bodies of subjects of the Russian Federation establish the maximum amounts of wholesale mark-ups and the maximum amount of retail mark-ups to actual selling prices.
The advertising of drugs and medical devices shall not:
- be addressed to minors;
- contain references to specific cases of curing diseases, improving the health of a person as a result of using such a drug;
- express gratitude to individuals in connection with the use of such a drug;
- create an idea of the advantages of such a drug by reference to the fact of carrying out research (pre-clinical and clinical studies) that is mandatory for the state registration;
- contain statements or assumptions about the presence of certain diseases or health disorders with the consumers;
- create an impression with a healthy person of a need to use the advertised drug;
- create an impression of being unnecessary to apply to a doctor;
- guarantee the positive effect of the advertised drug (medical device), its safety, effectiveness and the absence of side effects.
The advertising of drugs also shall not:
- represent a drug as a biologically active additive and food supplement or other non-medical product;
- contain statements that the safety and (or) effectiveness of the advertised drug is guaranteed by its natural origin.
Posting in advertising about the properties and characteristics of drugs and medical devices shall be permitted only within the indications contained in the duly approved instructions for application and use of the advertised drug (medical device).
Advertising of prescription drugs is prohibited in the Russian Federation as well as advertising of drugs or psychotropic substances permitted for use in medical purposes listed in narcotic drugs and psychotropic substances, the turnover of which is limited in accordance with the Russian legislation.
It is forbidden to conduct advertising campaigns accompanied by distribution of samples of drugs containing narcotic drugs and psychotropic substances.
Any advertising messages must comply with the instructions for the use of the drug.
All these requirements and restrictions are set forth in Art. 24 of the Federal Law dd 13.03.2006 No. 38-FZ “On Advertising”.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Drugs can only be sold in drug stores, healthcare organizations or by sole entrepreneurs that have license to carry out pharmaceutical activities, including retail pharmaceutical trade. Prescription drugs can be sold only upon the doctor’s prescription.
Drugs cannot be sold or delivered via post, as they are not subject to free sale.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
There are no special requirements and restrictions for individual channels. The only requirement refers to the amount of information about the presence of contraindications to use drugs (medical devices), the need to review the instructions for use or consult experts. Thus, in advertisements distributed in radio programs, the duration of such a warning should be not less than three seconds; in TV programs and in film and video services – not less than five seconds and should be allocated not less than seven percent of the area of the space, and in advertising distributed in other ways – not less than five percent of the advertising space.
Currently remote retailing of drugs is prohibited (see Decree of the Government of the Russian Federation dd 27.09.2007 No. 612 “On approval of the Rules for the sale of goods by remote means”, Presidential Decree dd 22.02.1992 No. 179 “On the types of products (works, services) and waste’s production, the free sale of which is prohibited”).
Federal executive bodies have the right to shut down sites that contain information on retail sales by remote means extrajudicially (Art. 5 of Law on Circulation of Drugs).
The State Duma of the Russian Federation passed in its first reading a bill allowing the distance (remote) sale of drugs sold without a doctor’s prescription (available at http://sozd.parliament.gov.ru/bill/285949-7).
20. May medicines and devices be advertised or sold directly to consumers?
Drugs and medical devices may be advertised or sold directly to consumers, that is subject to certain restrictions provided by law (please see Questions 17-18 of this section). Medical devices which use and operation require special skills (for instance, coronary stents) may be advertised on special events, organized among and for healthcare professionals.
Medicines and medical devices can be sold either with a doctor’s prescription or without it dependent on whether the drug is of prescriptive or OTC type. That is, for prescription drugs and medical products, there is an additional requirement to pre-receive a doctor’s prescription, but in this case, the sale itself is carried out directly.
21. How is compliance monitored?
Compliance in the sphere of healthcare is carried out by RZN and its territorial bodies (Chapter 13 of Law on Circulation of Drugs).
Compliance in the sphere of advertising in the context of healthcare is carried out by the Federal Antimonopoly Service (FAS of Russia).
22. What are the potential penalties for noncompliance?
Depending on the type of committed incompliance either administrative or criminal liability is envisaged.