Registration of APIs
Registration of APIs
NCPharm provides an assistance in registration of APIs of foreign origin in the territory of Russian Federation. For more information about the registration of APIs call by phone in Moscow: +7 (495) 984 7579.
The list of documents and data for inclusion of APIs in the State Register of Medicines:
I. Documents required to provide in accordance with the 61-Federal Law «On Circulation of Medicines»
1.1. The application for the state registration of pharmaceutical substance
1.2. A document confirming payment of state duty
1.3. A document confirming the compliance of the manufacturer's registered pharmaceutical substance requirements to the rules of production and quality control of drugs, issued by the competent institution of the country of manufacture. The document must be legalized in the established order.
1.4. Regulatory documentation project
1.5. The scheme of the manufacturing process of the pharmaceutical substance and its description
1.6. Manufacturer's certificate of analysis to the pharmaceutical substance
II. Data and materials necessary for the development of Normative documents draft and expert evaluation of pharmaceutical substance quality:
2.1. Documents confirming the legality of the applicant's actions
2.2. Internal production control of the manufacturing stages and intermediates
2.3. Control of starting substances and materials
2.4. Validation and / or qualification of the manufacturing process
2.5. Methods of quality control of pharmaceutical substances (analytical procedures)
2.6. Validation of analytical procedures
2.7. Serial analysis
2.8. Confirmation of permitting of the primary packaging material use in the country of production
2.9. Description of pharmaceutical substance package (weight, primary package, secondary package)
2.10. The results of stability studies in the claimed form of primary packaging, confirming the declared shelf life
2.11. Samples of API and standards in an amount necessary for the validation of the regulatory documents draft and passage of pharmaceutical expertise.