Registration of pharmaceuticals in Russia

Before exporting a pharmaceutical product to Russia it has to be registered at the Ministry of Health of the Russian Federation. In fact, it is the Department for registration of pharmaceuticals of the Federal Service for Health Control (109074 Moscow, Slav. Pl. 4, str.1; Tel: +7 095 298 4628; +7 095 925 6661, +7 095 298 3496, +7 095 298 3534, +7 095 298 5342) which is accountable for the registration procedure. Russia still has its own, unique regulatory system which does not correspond to U.S. or EU practices.

Not only do cultural and language barriers often become a challenge to foreign companies attempting to register pharmaceuticals by themselves; it is also the registration procedure which is quite complicated and the documents tend to be modified due to constant changes in the regulatory requirements. So the best way to accomplish registration of a pharmaceutical product in Russia is trough one of the following types of companies:

- a company incorporated in Russia and belonging to the Indian parent company,

- a Russian distributor/authorized agent or

- a consulting company.

For the registration procedure a company has to submit the following documents:

1. General documents:

* Application for the State registration of a pharmaceutical which includes the name of the pharmaceutical preparation, the name and the contact information of the manufacturer

* Name of the pharmaceutical preparation, including international non-proprietary name, scientific name in Latin, trade name and main synonyms

* List of active ingredients and components

* Recommended dosage, instruction for use

* Description of the drug and its packaging, shelf life and storage conditions

* Power of Attorney issued by the manufacturer to the authorized company for carrying out registration procedure (notarized original with apostil)

2. Certificates:

* Copy of Free Sales Certificate (must be notarized and apostilled)

* Copy of the license of pharmaceutical manufacture (must be notarized and apostilled)

* Copy of GMP certificate (must be notarized and apostilled)

* Copy of Certificate of manufacturer registration in their own country (must be notarized and apostilled)

* Original of Certificate of analysis of the drug and its active substance (must be signed and stamped by manufacturer)

* Copy of Certificate of trade mark (must be signed and stamped by the manufacturer)

* Information of registration of the drug in the country of the manufacture and in other countries

3. Information and test reports:

* Summary of the method of the drug manufacturing (must be signed and stamped by manufacturer)

* Complete description of the quantitative and qualitative control methods with references to the pharmacopoeia and specification (must be signed and stamped by manufacturer)

* Stability data of three drug series – by date

* Patterns of the spectrums and chromatograms of the drug

* Report of the pharmacological (specific) activity study substantiated the indications for use which are formed and described in the instruction

* Test report of the drug toxicity (acute, sub acute, sub chronic, chronic toxicity)

* Test report of the specific influences (cancerogenity, mutagenic and teratogenic effects, embriotoxicity, allergic and local-irritative effects)

* Clinical trial report of the medicine usage in clinic (the information which concerns only the drug that is produced by this manufacturer)

* Copies of publications of the medicine usage in clinics after its registration in the country of origin (the information which concerns only the drug that is produced by this manufacturer)

* Report of pharmakinetics of the pharmaceutical study and its bioequivalence to the original drug

* Summary information of the side effects, in comparison with other analogous medicines, used at the same indications

* Instruction for use (must be signed and stamped by the manufacturer)

4. Samples and package:

* Information of the material used for package: Certificates of the packaging materials (must be signed and stamped by the manufacturer)

* Color design of internal and external packages (Original and Russian version)

* Standard samples of the active substance for quality control

* Standard and referenced samples of the drug for the binding examination of quality (should be in the standard package)

The documents necessary for the registration include a certificate of analysis of the drug in the country of origin of the manufacturer, GMP certificate and information on registration of the drug in the foreign country. The Ministry of Health determines whether these approvals are sufficient for an exemption of the drug from clinical and other testing in Russia before issuing a registration certificate. Officially Russia does not recognize FDA and EU certificates.

According to the Law on Medicines, a fee in form of a state duty is to be paid for state registration and the registration should take no longer than six month. In reality, this fee has not been officially set by the government of the Russian Federation till now. Instead, an expertise body assigned for obligatory review by the Ministry of Health introduced significant charges ($ 12.000 per each item for foreign producers) for “expertise work”. And concerning the registration process it often takes longer than six months.

For further information regarding registration also have a look at the following web site: www.pharminform.ru. It belongs to the Russian consulting company Pharminform and offers information in English.

In fact, every company who wants to export products to Russia is recommended to work with reliable partners and consulting companies on drug registration issues. Please do expect “obstacles” and business practices which might not be common in your home country. But having a Russian speaking partner will definitely make your life much easier!

Please note that all products (cosmetics, vitamins, health care products, natural products etc.) can only be exported to Russia after their registration.

Note by MSI:

Many exhibitors ask us whether it makes sense to attend Apteka exhibition without having registered one’s products in Russia. As far as we can tell from 12 years experience with the pharmaceutical business on CIS markets, we can recommend presenting one’s products at our exhibition even before registering the product. Not only will exhibitors find out if Russian importers are interested in importing the product, Russian wholesalers are willing to sell the product or Russian pharmacists and doctors are ready to recommend or describe the product, they can also meet companies which will assist in the registration process.