Ukrainian legislation in the field of regulatory affairs on medicinal products. Orders, acts, directives that regulate procedure of state registration, renewal of registration and changes to the registration certificate of medicinal products. Cratia Ltd.

All legislation in the field of registration of medicinal products in English you can find at the website of our company. That page is updated frequently.

Currently the following legislation in the field of registration of medicinal products is valid in Ukraine :

1. Order of the Ministry of Health of Ukraine dated 26.08.2005 No. 426 “Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of Registration Certificate” with changes and amendments of Orders No. 95 dated 01.03.2006 and No. 536 dated 11.09.2007 including the annexes 1-20 [ Download as WinRar archive].

That Order describes general terms of the registration of medicinal products in Ukraine, list of required documents, terms and definitions, order of the expertise for new registration, renewal of registration and implementing changes to the valid registration certificate.

Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of Registration Certificate (As amended by MoH Ukraine Orders as of 01.03.2006 № 95, 11.09.2007 № 536)
Annex_1: Application for registration (renewal of registration, variations) of medicinal product in Ukraine (so-called “full Application”).
Annex 2: Structure of registration dossier (IRD also known as “simple” format).
Annex 3: Structure of registration dossier (CTD format).
Annex_4: Requirements to analytical, pharmaco-toxicological and clinical documentation.
Annex_5: List of variations (changes to approved registration documentation) type IA with mentioned terms, conditions and list of required documents.
Annex_6: List of changes that lead to new registration of medicinal product.
Annex_7: Application for variations (implementing changes to registration certificate and approved registration documentation).
Annex_8: Form and requirements to instruction for medicinal use (package leaflet) of prescription only and hospital medicinal products.
Annex 9: Requirements to primary and secondary package labeling (mock-ups).
Annex 10: Form and requirements to package leaflet of OTC medicinal product.
Annex_11: Requirements to homeopathic medicinal products that are allowed to be submitted for registration without clinical documentation.
Annex_12: Requirements to traditional herbal medicinal products for state registration in Ukraine.
Annex_13: List of documents (structure of the registration dossier) for state registration of active pharmaceutical substance in Ukraine.
Annex 14: Application for renewal of registration of medical product in Ukraine.
Annex_15: List of documents (structure of the registration dossier) for renewal of registration (re-registration) of medicinal product in Ukraine in “simple” (IRD) format.
Annex_16: Application for state registration (and renewal of registration) of active pharmaceutical substance in Ukraine.
Annex_17: Application for registration (renewal of registration, variations) of medicinal product in Ukraine (so-called “simple Application”).
Annex_18: List of required documents (structure of the registration dossier) for state registration of medicinal product in Ukraine (so-called “simple” format also known as IRD format).
Annex_19: List of required documents for renewal of registration of medicinal product in CTD format.
Annex 20: Form of cover guarantee letter.

That Law regulate the legal relationship related to creation, registration, manufacture and sale of the medicinal products in Ukraine . Information about registration of the medicinal products is mainly described in II chapter article 9, and IV chapter articles 13-16.

3. Decree of Cabinet of Ministers of Ukraine №376 [ Open as MS Word document] “ About approval of the order of State registration (renewal of registration) of medicinal products and adoption of the size of the State fees ”.

The Decree is mainly regulates the size of the state fees to the State Treasury of Ukraine during registration/renewal of registration.

4. Order of Ministry of Health №13 “ Order of the import of unregistered medicinal products for evaluation of the preclinical, clinical studies and State registration ”.

That Order describe the procedure and list of required documents for import of the not registered medicinal products, regents, active product ingredients, standards.

5. Order of the Ministry of Health of Ukraine [ Open as MS Excel document] “About approval of the prices of the State Pharmacological Center ”.

That Order describe size of the State fee for the expertise of the documentation for registration, renewal of registration and variation to the registration certificate with separation for generic (analogue) and original (new) finished medicinal products; full, bibliographic, reduced Application or Application for the fixed combination, in-bulk; radiopharmaceutical, sources of the radionuclides; homeopathic, herbal and mineral products; diagnostic products and active substances (API).

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