The list of required documents for GMP-recognition:
- Application form (download);
- Acknowledgement about quality of manufactured products (download);
- Acknowledgement on results of control performed by state control authorities (download);
- Full nomenclature of the products (download);
- Dossier of the manufacturing site (download);
- Copy of the GMP certificate in the country of manufacturer;
- Copy of the last GMP-control report issued by state authority of the manufacturer’s country;
- Manufacturing license of the site(s) that mentioned in application (if applicable);
- Copy of Plant Master File.
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