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 GBP 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 (the “BCP”), i.e. products containing cultivated living cells of humans, used in various studies and 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 research;
- healthcare organizations.
2. What is the authorization process for the marketing of generic versions of these products?
The authorization process for a generic drug is similar to authorization of the original drug, more simplified though. In particular, no personal preclinical and clinical trials are required from the applicant, bioequivalence trials are required instead.
3. What are the typical fees for marketing approval?
The government fees for marketing authorization issuance are the following:
- for a drug: around USD 135 (RUB 10 000);
- for a medical device: around USD 95 (RUB 7 000);
- for a BCP: around USD 70 (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: marketing authorization validity for a drug to be registered for the first time is 5 years. Upon the expiration of this 5-year term, the marketing authorization can be renewed for an indefinite term subject to confirmation of its registration (re-registration). In some cases (due to pharmacovigilance issues), a renewed marketing authorization can be issued for 5 years.
Marketing authorizations of those drugs that (A) were registered under national rules (under Russian laws) before 2021; and (B) have valid Russian marketing authorization, are valid until their expiration date, but no later than December 31, 2025. For these drugs, the procedures for making changes and confirming their registration in compliance with the EAEU regulations will be available until December 31, 2025.
Medical devices: marketing authorization is granted for an unlimited period.
BCP: the first marketing authorization is issued for 5 years. Upon the marketing authorization’s expiration, the marketing authorization must be renewed every 5 years (the number of renewals is unlimited) subject to confirmation of its registration.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Marketing authorization for some drugs may be issued subject to the fulfillment of certain obligations if the applicant can confirm (justify) that it is impossible to provide complete data on the effectiveness and safety of the drug under normal conditions of its use for one of the following reasons:
- The drug’s intended indications for use are so rare that the applicant cannot reasonably expect to receive comprehensive confirmation of the evidence of the effectiveness and safety of the drug;
- Complete information about the effectiveness or safety of the drug cannot be provided with the existing scientific methods of research;
- Obtaining information about the efficacy or safety of the drug would be contrary to generally accepted principles of medical ethics.
Registration under the conditions may include the following:
- The applicant must complete, within the time limit set by the authorized body of the member state, a certain safety or effectiveness research program, the results of which should allow for a reassessment of the benefit-risk ratio;
- The drug in question can only be dispensed by prescription and to be used in certain cases only under strict medical supervision, possibly in a hospital, and in the case of radiopharmaceuticals under the supervision of a specially authorized person;
- The instruction for medical use, company core data sheet, marketing authorization, and any medical information must contain information that draws the attention of the medical professional to the fact that the available characteristics of the drug in question are insufficient in terms of confirming certain aspects of the effectiveness or safety of the drug.
If a drug is registered under the conditions, its marketing authorization has an annex specifying these conditions (restrictions for the use, additional obligations that must be fulfilled by the marketing authorization holder).
Besides, 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?
Yes, but only those that are issued within the EAEU and recognized under the EAEU Rules.
7. Are parallel imports of medicines or devices allowed?
Until 2018 parallel imports of goods were 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 the trademark holder or with their consent. Besides, the recent approach of Federal Antimonopoly Service (decisions on cases No. 1-14-163/00-08-18 and 1-14-164/00-08-18) is that the right holder’s ignoring or groundlessly rejecting to permit the import of the goods for the potential importers both constitute an act of unfair competition.
In early 2018, the Constitutional Court checked the validity of the regime of parallel imports and related legal remedies. The Constitutional Court recognized the provisions of the Civil Code of the Russian Federation as valid and compliant with the Constitution. However, the Constitutional Court restricted IP holders’ authority to control the importation of goods into Russia and 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 importers of counterfeit products.
- parallel imported original goods cannot be confiscated and destroyed, if only such goods bring inadequate quality or pose a 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?
Medical practitioners must comply with the following limitations in their interactions with organizations engaged in the development, production, and (or) sale of drugs, medical devices, organizations that have the rights to use the trade name of a drug, organizations that wholesale drugs, pharmacy organizations (their representatives, other individuals and legal entities that carry out their activities on behalf of these organizations) – medical practitioners are not allowed to:
- accept gifts, cash (unless it’s a fee for conducting clinical trials or scientific and(or) pedagogic activities), including payment for entertainment, recreation, travel to the place of rest, as well as participate in sponsored entertainment events;
- agree 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 their representatives for the purposes not related to the conduct of clinical trials of drugs and medical devices or participation in activities aimed at improving the professional level or providing information related to the implementation of monitoring the safety of drugs and medical devices.
* Except for cases related to the conduct of clinical trials of drugs and medical devices
Besides, medical practitioners are not allowed to:
- when prescribing a course of treatment to a patient, provide false and (or) incomplete information about the used drugs and medical devices, including hiding information about the availability of similar drugs and medical devices;
- 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?
The EAEU Good Manufacturing Practice (approved by the decision of the Council of the Eurasian Economic Commission dd 03.11.2016 No. 77) entails basic provisions for the manufacturing of drugs. As for the manufacturing of medical devices, some basic grounds are established by the 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 Russian governmental body responsible for enforcing the regulatory framework concerning 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 the EAEU Good Manufacturing Practice 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 adopted 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. Russian 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 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 the 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 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 drug storage rules establish the basic requirements for the premises, equipment, as well as 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 device 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 (usage method);
- dosage or concentration;
- strength measured in units of the activity or dose number per package;
- pharmaceutical form;
- prescription status;
- storage requirements;
- cautionary warning;
- bar code;
- two-dimensional bar code for track and trace.
The general rule is that labeling information must be in Russian and easy to read.
Starting from July 01, 2020, a two-dimensional bar code for track and trace is mandatory for drug circulation. A two-dimensional bar code for track and trace makes it possible to monitor a drug’s movement from manufacturer to end-consumer. Drugs passed to circulation before the specified date keep valid till the expiry.
Additional requirements may be established for the specific type of drug or its production conditions: 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, etc.
Devices labeling must include essentially the following information on the secondary (consumer) package:
- product name (type and/or brand name);
- identification information (designation);
- manufacturer’s information (might be excluded from consumer pack if specified in package leaflet) and representative information for the products manufactured not in the territory of the EAEU;
- information about medical drug or biological materials containing in a device;
- batch and serial number (might contain the date of production);
- best before date;
- storage and/or circulation requirements;
- information on sterility and sterilization method (if applicable for device type);
- cautionary warning.
Additional requirements may be established for a specific type of device or its production conditions: e.g. for single-use devices, individually produced devices, demonstrational devices.
15. What additional information may be included in labeling and packaging?
Additional information may be included in the secondary (consumer) package given its compliance with the drug’s registration dossier.
16. What items may not be included in labeling and packaging?
The applicable regulations in Russia and the EAEU mainly establish only the list of mandatory information to be included in labeling. The list of prohibited information is not explicitly stated. However, based on the existing regulations, for instance, the following information cannot be included:
- Information that is not compliant with the drug’s registration dossier;
- Selective information specified in “clinical data” and “pharmacodynamic properties” sections of the general characteristics of the drug and the equivalent sections of the instructions for medical use (leaflet) of this drug.
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” Chapter) 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.
As for the advertising requirements, general advertising rules established by Art. 5 of the Federal Law dd 13.03.2006 No. 38-FZ “On Advertising” are to be applied together with special rules for advertising of drugs and medical devices established by Art. 24 of the said Federal Law.
Special rules for advertising include the following:
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 drug 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 are 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 a 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.
Advertisements of drugs and medical devices must generally include information about the presence of contraindications to use drugs (medical devices), the need to review the instructions for use, or consult experts. In advertisements distributed in radio programs, the duration of such a warning should be not less than 3 seconds; in TV programs and film and video services – not less than 5 seconds and should be allocated not less than 7% of the area of the space, and in advertising distributed in other ways – not less than 5% of the advertising space. This obligation is not applied to the advertisements to be distributed in the venues of medical or pharmaceutical exhibitions, seminars, conferences, and other similar events, as well as in specialized printed publications intended for medical and pharmaceutical practitioners, and to other advertising, the consumers of which are exclusively medical and pharmaceutical practitioners.
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 pharmacy stores, healthcare organizations, or by sole entrepreneurs that have a license to carry out pharmaceutical activities, including the retail pharmaceutical trade. Prescription drugs can be sold only upon the doctor’s prescription.
Besides, starting from April 03, 2020, distance selling of drugs is allowed subject to the following requirements:
- The following types of drugs are excluded: prescription drugs, narcotic and psychotropic drugs, alcohol-containing drugs with a volume fraction of ethyl alcohol of more than 25%;
- Distance selling can only be performed by pharmacy organizations that have both (1) license to carry out pharmaceutical activities and (2) special distance selling permit issued by RZN;
- Distance selling of drugs is to be compliant with the applicable regulations (including the rules for distance selling of drugs approved by Resolution of the Government of the Russian Federation dd 16.05.2020 No. 697; rules for the sale of goods under a retail sale agreement approved by the Resolution of the Government of the Russian Federation dd 31.12.2020 No. 2463).
Delivery of drugs ordered via distance selling is carried out by an employee of the pharmacy organization or another (third-party) organization under the relevant agreement. When delivering orders containing thermolabile drugs, vehicles are used to ensure the maintenance of the required temperature regime, or other appropriate equipment (isothermal packaging, thermal container, etc.).
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, general and special rules for advertising of drugs and medical devices are to be applied (please, refer to Question 17). Different social media can establish their additional requirements for advertising posts and sanctions for the failure to comply with them (e.g. blocking a user’s account).
20. May medicines and devices be advertised or sold directly to consumers?
Drugs and medical devices may be advertised or sold directly to consumers, which is subject to certain restrictions provided by law (please, refer to Questions 17-19). 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 the 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 noncompliance, either administrative or criminal liability is envisaged.