Russian Certifcate of Pharmaceutical Product (CPP).
Who: Minpromtorg is responsible for issue of Certificate of Pharmaceutical Product in Russia.
Application: Application should contains information about name of product, adress and head of applicant, number and date of manufacturing licence, adress of sited involved in manufacturing process, number of marketing authorization (MA) and the following documentation:
- Manufacturing Licence (Mfg. lic.)
- GMP certificate (if available)
- 5 CoA (certificates of analysis of 5 consecutive batches)
- Normative Documentation
- Trade Mark certificate
Note: All above documents should be provided as copies with stamp of applicant.
Duration: Duration of procedure 30 calendar days.
State Fee: Free
Validity of Russian CPP: 3 years.
State register of issued CPP certificates. (will be added later)
Form of Russian CPP certificate. (will be added later)
How to get Russian CPP (official document).