Registration of active pharmaceutical ingredients (substances) – inclusion of drug substances (API - active pharmaceutical ingredients) in the State Register of drugs

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Registration of active pharmaceutical ingredients (substances) – inclusion of drug substances (API - active pharmaceutical ingredients) in the State Register of drugs

Accroding to New Federal Law No. 61-ФЗ "On drugs", the drug substances authorization is maintained.

At present, substances (API) used in the manufacture of drug products and substances not used in the manufacture of drug products are to be included in the Register.

We can give you recommendations on new requirements, help you prepare documents, compile the dossier and monitor the process of the authorization of substances used in the manufacture of drug products and drug substances not used in the manufacture of drug products.

The formal term of the inclusion of drug substances in the Register is 60 workdays. This term does not include time needed for expert evaluation of the drug substance quality.

The list of documents necessary for the authorization of drug substances not used in the manufacture of drug products.
State fee for the inclusion of the drug substance in the State Register of drugs is 100,000 rubles. (Fees).

 
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