Documents for GMP certification
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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: |
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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: |
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List of documents required for sanitary examination of cosmetic products in Ukraine: |
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The list of required documents for registration of special food supplements (dietary supplements, BAS) in Ukraine |
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List of required documents for conduction of confirmation procedure to technical regulations in Ukraine |
LIST OF REQUIRED DOCUMENTS FOR CONDUCTION OF CONFIRMATION PROCEDURE TO TECHNICAL REGULATIONS
1. Application filled in by applicant of authorized person;
2. Power of Attorney to represent interest of applicant in Ukraine;
3. CE Certificate (assessment of conformity to requirements of the directive);
4. QMS Certificates (ISO 13485);
5. QMS documents:
- Policy in quality sphere,
- Goals in quality sphere,
- organizational chart of the enterprise,
- quality guide,
- documented procedures (methods): management of documents, management of records, analysis by management of enterprise, internal audits, discrepancies management, corrective and preventive actions, organization and control of production, withdrawal from the market of non-conforming products;
6. Technical file for products ( with analysis of risks, description of composition of the product, used raw materials, control methods);
7. The list of standards by which the products are manufactured or other ND (normative documents: pharmacopeia and others);
8. Materials on clinical trials from the manufacturer;
9. Test reports of product in the laboratory, with ISO 17025 competence and recognized by ILAC to meet:
- The technical requirements;
- Biological tests;
- Electromagnetic compatibility (the equipment);
- Bacteriological studies (if there is this requirement for medical devices). Protocols have to be provided with the documents certifying the competence of the laboratory;
10. Quality certificates (certificate of quality), which are issued by the manufacturer, the test reports in the laboratory of the manufacturer (if any);
11. Declaration of Conformity;
12. Instruction on use;
13. Labelling project.
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List of documents for registration of substances |