Following list of documents has to be submitted to the state authorities for confession of GMP.

1. Application (Annex 1).

2. Acknowledgement about quality of manufactured products (Annex 2).

3. Acknowledgement on results of control performed by state control authorities (Annex 3).

4. Full nomenclature of the products (Annex 4).

5. Dossier of the manufacturing site (Annex 5).

6. Copy of the GMP certificate.  

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

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