registration almost there

Then the $$$ and Rubels, begin and the world wakes up,

This is why as well as the Ministry of Health office move, it takes a while to get Pharmaceuticals registered.

The list of necessary documents for the registration of foreign drugs in the Ministry of Health of Russian Federation

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

2. The name of the pharmaceutical preparation, including international non-proprietary name, scientific name in Latin, trade name and main synonyms

3. List of active ingredients and components

4. Recommended dosage, instruction for use

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

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

Certificates:

7. A copy of the Free Sales Certificate (must be notarized and apostilled)

8. A copy of the license of pharmaceutical manufacture (must be notarized and apostilled)

9. A copy of the GMP certificate (must be notarized and apostilled)

10. A copy of the Certificate of manufacturer registration in their own country (must be notarized and apostilled)

11. The original Certificate of analysis of the drug and its active substance (must be signed and stamped by manufacturer)

12. A copy of the Certificate of trade mark (must be signed and stamped by the manufacturer)

13. Information of registration of the drug in the country of manufacture and other countries

Information and test reports:

14. The summary of method of the drug manufacturing (must be signed and stamped by manufacturer)

15. The complete description of the quantitative and qualitative control methods with references to the pharmacopeia and specification (must be signed and stamped by manufacturer)

16. Stability data of three drug series - by date

17. Patterns of the spectrums and chromatograms of the drug

18. Report of the pharmacological (specific) activity study substantiating the indications for use which are formed and described in the instruction

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

20. Test report of the specific influences (cancerogenity, mutagenic and teratogenic effects, embrio-toxicity, allergic and local-irritative effects)

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

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

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

24. The summary information of the side effects, in comparison with other analogous medicines, used at the same indications

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

Samples and package:

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

27. The colour design of internal and external packages (Original and Russian version)

28. Samples of active substance for quality control

29. Standard and referenced samples of the drug for the binding examination of quality (must be in the standard package).

The documents necessary for 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, at its own discretion, 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.

The total number of drugs registered in Russia is approximately 17,000 while in the majority of Western countries this number reaches 20,000. The registration procedure is not transparent. The lists of registered drugs are more or less published. However, the information on drugs under registration and on the status of the registration is not available. Confidentiality of the files provided by the applicant is not guaranteed. The registration system is unable to protect access to the market of fake drugs and low-quality (sometimes dangerous) products. To combat these problems, Russia introduced a new certification system which applies to all drugs produced in Russia and imported to the country.

Certification

On April 29, 2002, Government Resolution #287 added medicines to the List of Products subject to mandatory conformity assessment (certification) in Russia. Previously the drugs were subject to selective, batch-based certification at each stage of their circulation in the market. Certificates for foreign drugs were issued based on quality certificates provided by the manufacturers. The new certification system which came into effect on December 15, 2002, requires total control and inspection of locally made and imported medicines. The Ministry of Health together with the State Standards Committee accredited 8 regional certification centers located in Moscow, St. Petersburg, Nizhny Novgorod, Novosibirsk, Yekaterinburg, Khabarovsk and Rostov-on-Don. Well-established Russian and foreign drug manufacturers may undergo simplified certification procedures. All other companies must undergo full-scale quality and safety testing prior to customs clearance.

The certification, required now for each and every batch of medicines entering the market costs 2,000 rubles for domestic companies and 3,000 for foreign firms. Certificates previously required at each stage of the sales chain were replaced by a single certificate issued when the product enters the market. The new certification system has led to an additional cost of storing products in bonded warehouses at the border while tests are carried out. Testing may take up to several months. The increased costs have led to an increase in retail drug prices.

The Ministry of Health presents the new certification system as a tool to combat counterfeit drugs as well as toughen control over imported drugs. To expedite the certification procedure for well-established pharmaceutical suppliers the Ministry of Health has issued a special instruction making the procedure for such companies very simple. The MOH publishes a list of qualifying companies. Currently 119 of the 205 companies on the list are foreign companies. Currently, both the Association of International Pharmaceutical Manufacturers (AIPM), which represents 50 foreign firms that account for 65 percent of imports and 40 percent of the pharmaceutical market in values terms, and the American Chamber of Commerce in Russia are actively working to eliminate this administrative barrier for foreign manufacturers.

The new Law on Technical Regulations, which came into effect in the summer of 2003 is aimed at reforming the existing certification system and will bring the process into compliance with international standards by making a shift from obligatory certification to technical regulations, clear-cut standards and manufacturers certificates of conformity. However, a lot of issues still remain unresolved. According to the law, the transition period to the new system will take seven years. In addition, there is a lot of uncertainty about which international standards Russia will accept, which standards should be obligatory and which voluntary, and what the role of the government body should be in development and enforcement of the standards.

Generally, the Russian drug registration and certification system is very different from the practices adopted in major developed countries. Therefore, U.S. companies are recommended to work with experienced distributors or consultants on registration and certification of their products. The registration procedures are quite complicated and there are many gray areas. However, many U.S. companies have established good working relations with the Ministry of Health and successfully overcome difficulties which they are confronted with when they register or re-register medical products in Russia. The good thing about the system is that it is pretty centralized and the applicant needs to mainly deal with a few departments within the Ministry of Health. Again, legal advice and assistance from the distributor is strongly recommended.

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