Documents for GMP certification

Документы для процедуры признания GMP The list of required documents required for procedure conduction on conformity of medicines production conditions with good manufacturing practices, according to the order of MOH of Ukraine № 452:

1. – Application for issuance of certificates on conformity to GMP requirements, filled with the language of the applicant;

    – Application for issuance of conclusion on conformity to GMP requirements, filled with the language of the applicant;

2. Copies of registration applications on the drug, which were submitted to the MOH of Ukraine or copies of variation applications. These documents are submitted if they are available and are assured by the signature / stamp of the applicant;

 3. Duly certified copy of the official document, which gives the right to carry out activities for the production of medicines and issued by the relevant state authority of the country where the production is located on the manufacturing site, which is specified in the Application and duly certified translation into Ukrainian and English languages. If under the law of the manufacturer country the manufacturing license exists only in electronic form, the manufacturer has to provide listing with reference to the official site, authenticated by the signature / stamp of the applicant and with Ukrainian translation;

If the above mentioned document is in the database of EudraGMP, the applicant provides the link to following database. In this case the copy of document is also certified by the Applicant;

 4. Duly certified copy of the official document issued by the state authority of the country where the production is located about the compliance of production site to GMP requirements which was specified in the application (if available), duly certified copy of the annexes to the document with a list of drugs (if available) and duly certified translation thereof into the Ukrainian and English languages.

If the above mentioned document is in the database of EudraGMP, the applicant provides the link to following database. In this case the copy of document is also certified by the Applicant;

 5. Copy of the production site dossier (Site Master File) and its translation into Ukrainian and / or English, certified by the applicant (except vendors, manufacturing facilities that are located on the territory of country – PIC/S member).

 6. Certified by the applicant copy of report, compiled from the latest inspection by the competent authority of the PIC/S member (for producers which production facilities are located outside the territory of the PIC/S member). The inspection has to be made no later than 3 years prior the application. In case of manufacturer refusal to provide copy of the report, the applicant may appeal to State Service of Ukraine on Drugs with appeal on the implementation of request for such report by the authorized body of the PIC/S member, which carried out the inspection;

 7. Information on the last inspection carried out by the WHO retraining program. The inspection has to be made no later than 3 years prior the application;

 8. Reference on the quality of products filled in with the language of the applicant;

 9. Reference on inspections of manufacturing sites, conducted by state control, filled with the language of the applicant;

10. List of medicines that are registered in Ukraine and/or planned to be registered and production of which is already conducted (if any), or are planned to be at the site specified in the application completed in the language of the applicant;

This list has to be submitted in writing and in electronic form;

11. Copies of medicinal product certificates (CPP) for international trade (for unregistered medicines, which are scheduled for registration or renewal in Ukraine);

12. Guarantee Letters completed in the language of the applicant.

See also:

sertifikacziya-proizvodstva-lekarstvennyx-sredstv Certification of drugs manufacturing site