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Recognition of GMP certificate

The recognition procedure is based on the following legislation:

Ratification procedure of certification of medication manufacturing Order of the Ministry of Health of Ukraine No.391 dated on 30.10.2002

Annex 1 Annex 2 Annex 3 Annex 4 Annex 5


Structure of the dossier for GMP recognition.

Following list of documents is required for evaluation of the procedure of recognition of certificate of compliance to good manufacturing practice:

1. Application for recognition

2. Information about quality of manufactured products

3. Information about results of inspection performed by state inspection authorities
4. Full list of the manufactured products

5. Site master file

6. Copy of the GMP certificate.

7. Copy of the last GMP-control report issued by state authority in the manufacturer’s country.

8. Manufacturing license of the site(s) that mentioned in application (if applicable).