ENGLISH ABOUT COMPANY SERVICES PRODUCTS QUALITY SERVICE PRESS CENTER CONTACTS www.ncpharm.ru / Useful information / Registration of pharmaceutical substances HELPFUL INFORMATION Pharmaceutical substances Registration of pharmaceutical substances Dopamine instruction Amoxicillin instruction Remantadine instruction COMPANY'S NEWS 03/20/2017 NCPharm participates in IPhEB & CPhi Russia 2017 Registration of pharmaceutical substances NCPharm assists in the registration of pharmaceutical raw materials of foreign origin on the territory of the Russian Federation. For detailed information on the registration of pharmaceutical substances, call in Moscow: +7 (495) 984 7579 List of documents and data for entry into the state register of Medicines, pharmaceutical substances: I. Documentation required for submission in accordance with 61-FZ "On the Circulation of Medicines" 1.1. Application for state registration of a pharmaceutical substance 1.2. Document confirming payment of the state fee 1.3. A document confirming the compliance of the manufacturer of the registered pharmaceutical substance with the requirements of the rules for organizing the production and quality control of medicinal products, issued by the competent authority of the manufacturer's country. The document must be legalized in the prescribed manner. 1.4. Draft regulatory documentation 1.5. Scheme of the technological process for the production of a pharmaceutical substance, its description 1.6. Manufacturer's Certificate of Analysis for Pharmaceutical Substance II.Data and materials required for the development of the draft Normative documentation and the assessment of the quality of the pharmaceutical substance by the expert of the FGBU NTs ESMP: 2.1. Documents confirming the legality of the applicant's actions 2.2. Intra-production control of production stages and intermediate products 2.3. Control of raw materials and materials 2.4. Validation and / or qualification of the manufacturing process 2.5. Quality control methods for pharmaceutical substances (analytical procedures) 2.6. Validation of analytical procedures 2.7. Serial analysis 2.8. Confirmation of permission to use the primary packaging material in the country of origin 2.9. Description of the packaging of the pharmaceutical substance (weight, primary packaging, secondary packaging) 2.10. The results of stability studies in the declared form of the primary packaging, confirming the declared shelf life 2.11. Samples of pharmaceutical substances and standards in the amount required for approbation of the draft regulatory documentation and the passage of pharmaceutical expertise. © 2010 - 2017 NC Pharm supplier of pharmaceutical substances. All rights to logos and trademarks belong to their respective owners. Tel./Fax: +7 (495) 984 7579 E-mail: info@ncpharm.ru