Traditional Medicines and OTC Products
A brief overview of the situation regarding traditional medicines and OTC products in Russia. 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 are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional medicines are treated as nutrition products (dietary products or health supplements, as the case may be) under Russian law. Thus, the basic regulatory requirements for traditional medicines include:
- mandatory confirmation of compliance with requirements of regulatory documents;
- traditional medicines must satisfy the human physiological needs in necessary substances and energy, comply with mandatory requirements of normative documents to the permissible content of chemical (including radioactive), biological substances and their compounds, microorganisms and other biological organisms representing health hazard to present and future generations;
- manufacturing is to be carried out in accordance with technical documents, subject to the requirements of regulatory documents;
- for the manufacturing only raw nutrition materials, which quality and safety meet the requirements of regulations, shall be used; it is not allowed to use raw nutrition materials produced with use of supplementary feeds, animal growth stimulants (including hormonal drugs), separate kinds of medicines, pesticides, agrochemicals and other substances and connections hazardous to human’s health.
Herbal medicines are considered as drugs, thus, regulatory requirements for herbal medicines are the same as requirements for drugs in general.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Traditional medicines can be advertised directly to the public given the requirements provided by law for such an advertising.
Ground rules for advertising of traditional medicines are envisaged in the Federal Law dd 13.03.2006 No. 38-FZ “On advertising”. Namely, advertising of traditional medicines must not:
- create the idea that they are drugs and/or possess any healing properties;
- contain a reference to specific cases when people have been cured, when their condition has improved as the result of using such supplements;
- contain an expression of gratitude by individuals in connection with the use of such supplements;
- incite somebody to refuse to practice healthy nutrition;
- create the impression that such supplements have an advantage by making a reference to the fact of completion of a research that is compulsory for the state registration of the supplements, and also to use the results.
Herbal medicines can be advertised directly to the public keeping in mind general drugs advertising rules (for more details see Question 20 in Marketing, Manufacturing, Packaging & Labeling, Advertising section).
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
The following information shall be provided in Russian:
- nutritional value (caloric content, protein, fat, carbohydrates, vitamins, macro-and microelements);
- appointment and conditions of application;
- storage conditions (if certain requirements are established);
- date of manufacture and date of packaging.
Herbal medicine must have the inscription “the products have passed radiation control” on its secondary (consumer) package.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
Regulatory requirements for over-the-counter (OTC) drugs are the same as requirements applied to drugs in general.
5. Are there any limitations on locations or channels through which OTC products may be sold?
OTC drugs can be sold in drug stores, healthcare organizations or by sole entrepreneurs that have license to carry out pharmaceutical activities, including retail pharmaceutical trading.
6. What health, advertising, and marketing claims may be made for OTC products?
General labeling rules are applied (see Question 14 in Marketing, Manufacturing, Packaging & Labeling, Advertising section). “Over-the-counter use” mark shall be specified in Russian.
7. Can OTC products be marketed or advertised directly to the public?
Yes, according to the Federal Law dd 13.03.2006 No. 38-FZ “On advertising” OTC products can be advertised directly to the public. In an advertisement an announcement of OTC product’s properties and characteristics is permitted only to the extent of indications contained in instructions for application of such objects of advertising that are approved in the established procedure. Moreover, an advertisement shall be accompanied by a warning of the existence of counter-indications for the application and use thereof, as well as the necessity to be read the instruction or to consult with the specialist.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Before 2011 there was a list of OTC products kept by Minzdrav. However, lately it was nullified. As of now there are no requirements established by Russian laws as for the procedure for the transfer of the drug to non-prescription one and the criteria for classifying the drug in this category.
However, this issue is clarified on the supranational level within Eurasian Economic Union (where Russia is a member).
In general, criteria for classifying a drug as prescription-only are the following:
- even when proper used, but without medical supervision can cause direct or indirect harm to human health;
- often used incorrectly and, as a result, can cause direct or indirect harm to human health;
- contain substances or compounds, the effect of which and (or) undesirable reactions to which are not sufficiently studied (subject to further study);
- are administered extrabuccal (usually) (i.e. escaping the gastrointestinal tract, e.g. intravenous injection)
Consequently, if a drug fulfills at least one of the aforementioned criteria, then this drug is to be regarded as prescription-only.
9. What are the requirements for the importation of either traditional medicines or OTC products?
Importation of traditional medicines is carried out on the basis of a decision of the customs authority, made upon the results of the documentary inspection. At the same time, contract for the supply of nutrition products, including dietary food, should contain mandatory obligations to comply with the requirements of regulatory documentation in relation to nutrition products. Importation is prohibited if the nutrition product has not passed the procedure of its state registration.
It is possible to import OTC drugs, which quality is confirmed by the certificate of their manufacturer, certifying compliance of imported drugs with the requirements of pharmacopoeia monograph or, in its absence, – requirements of regulatory documentation or regulatory document. The importer who intends to import OTC drugs must have the relevant admittance issued by Minzdrav.