+7(495)665-81-35
+7(843)226-03-63
Registration of medicines and pharmaceutical substances is carried out according to the Federal law «About the manipulation of medicines» since September 01, 2010. The «AiLFARMA» company offers a complex of services in the state registration of medicines and pharmaceutical substances of domestic and foreign production, as well as services to make changes and confirm the registration of drugs, providing a multilateral approach to solving problems arising in the implementation of this procedure.

List of documents for the medicine registration

 

1. An apostilled power of attorney from the manufacturer to the legal entity performing registration of a drug.
Certificates:
2. An apostilled free-sale certificate (or a certificate of a pharmaceutical product) (original or a copy certified by a notary)
3. An apostilled production certificate of the manufacturer (a copy certified by a notary)
4. An apostilled GMP Certificate (original or a copy certified by a notary)
5. Certificate of registration in the country of origin certified by the seal of the manufacturer.
6. Certificates of analysis for the end product and the active substance, both certified by the company's seal.
7. If the trademark is registered, a copy of certificate of trademark registration in the Russian Federation certified by the company's seal.
8. Information about drug registration in other countries (where, how long) certified by the company's seal.
Test Information and Data Sheets:
9. A resume of manufacturing process, certified by the company's seal.
10. Full description of analysis methods by quantity and quality control (with a reference to Pharmacopoeia + specification)
11. Stability data based on drug bathes from at least three lots confirming the declared shelf life period in all registered types of immediate packaging.
12. Drawings of specters and chromatograms
13. A study report of pharmacological (specific) activity justifying all indications specified in the instruction
14. A toxicity report (acute, subacute, subchronic, chronic toxicity).
15. A study report of specific activities (carcinogenicity, mutagenic and teratogenic activity, embryo-toxicity, properties of a allergen and local irritant etc.)
16. Reports of clinical trials.
17. Data on drug usage in a clinic an publications upon its registration (copies of publications) (only about a drug produced by a company)
18. Data on bioequivalence (for pills, capsules, powder for suspensions)
19. Information on adverse events as compared to similar drugs identical action.
20. Instruction for medical usage
Samples and packaging:
21. Information about the material used for drug packaging: certificates for packaging materials and package confirming their usage for medical purposes certified by the company's seal.
22. Samples of external and inside packaging (in original and in Russian) in color.
23. Standard samples of an active substance required for quality control.
24. Production and standard drug samples for mandatory quality expertise of samples of drugs presented for state registration

 

Bank details for the transfer of state duty:

Short name: Ministry of Health of Russia;

Address: 127994, Moscow, Rakhmanovsky lane, 3/25, p 1,2,3,4,

Beneficiary: INN  (Taxpayer identification number) 7707778246 KPP  (Tax registration reason code) 770701001

Transregional operational FTD (Russian Federation Ministry of Health) personal account 04951000560

Beneficiary’s bank: Operations Department-1 of Bank of Russia Moscow

Account: 40101810500000001901



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Contacts

Address: c. Moscow, 2-й Syromyatnicheskiy str., д.1
Phone: +7(495)665-81-35
Address: г. Kazan, Pr. Yamasheva 46/33
Phone: 8 (843) 226-03-63 ,
Email:
WhatsApp: +7(495)665-81-35
Skype: ailfarma@mail.ru

AiLFarma - licensing of medicines
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