MIKHAILYUK, SOROKOLAT & PARTNERS Patent and Trademark Attorneys ISO 9001 CERTIFIED
MIKHAILYUK, SOROKOLAT & PARTNERS Patent and Trademark Attorneys
ISO 9001 CERTIFIED


GMP conformity assessment for the State registration of medicinal products in Ukraine

In accordance with Decree of the Cabinet of Ministers of Ukraine dated May 26, 2005 No. 376 with last amendments dated August 8, 2016, the compliance of production of medicinal products with Good Manufacturing Practice is checked during the examination of the registration materials submitted for state registration (re-registration).

The procedure of examination of the documents on GMP conformity assessment is conducted by the State Administration on Medicines and Drugs Control of Ukraine and is free.

For manufacturing sites that have a GMP certificate issued by the competent authority of the Member of PIC/S, GMP conformity assessment is carried out by examination of provided documents only, while for manufacturing sites that do not have GMP certificate issued by the competent authority of the Member of PIC/S, GMP Conformity assessment is made both by examination of provided documents and conducting of mandatory inspection of the manufacturing site with the departure to the plant.

For conducting of the procedure of GMP conformity assessment it is necessary to provide Application for issuance of the certificate or the conclusion of compliance together with the following documents:

  • legalized Power of Attorney from the applicant to the representative;
  • copy of the registration form for State registration (re-registration) of medicinal product that has been submitted to the State Expert Centre of Ministry of Health Protection of Ukraine;
  • legalized copies of the Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process and issued by the competent authorities of countries-manufacturers or their printouts from the official database;
  • legalized copies of the official documents issued by the state authorities of the countries where the manufacturing sites are located about the compliance of manufacturing site to GMP requirements and/or legalized GMP certificates issued by the competent authorities of the Members of PIC/S (for all manufacturing sites involved in manufacturing process) or their printouts from the official database
  • certified copies of dossiers of the manufacturing sites - Site Master Files (required for all non-EU and non-PIC/S manufacturing sites involved in manufacturing process);
  • certified copies of last reports on inspections of the manufacturing sites by the competent authorities of the Members of PIC/S that were conducted not earlier than 3 years before submitting the Application (if available, for all non-EU and non-PIC/S manufacturing sites involved in manufacturing process);
  • general list of medicinal products that are registered in Ukraine and/or have been submitted for State registration (re-registration);
  • report on the quality of medicinal products that are registered in Ukraine or have been submitted for State registration (re-registration);
  • report on the results of all inspections conducted by the competent authorities not earlier than 3 years before submitting the Application;
  • certified copies of certificates of a pharmaceutical product (free sale certificates) on medicinal products that have been submitted for State registration (re-registration) or copies of their registration certificates issued by the competent authorities of country of applicant/manufacturer or by another country, the Regulatory Bodies of which apply high quality standards and where the said products are marketed (for medicinal products not registered in Ukraine), etc..

Procedure of the conformity to the GMP requirements include the following steps:

  • submission of the application form and documents to obtain a certificate or conclusion;
  • inspection of manufacturing sites (if manufacturing sites do not have GMP certificate issued by the competent authority of the Member of PIC/S within last 3 years);
  • receipt of a certificate or conclusion of compliance to the GMP requirements and/or report of compliance or non-compliance to the GMP requirements.

For manufacturing sites located in countries of PIC/S members and for manufacturing sites that have a GMP certificates issued by the competent authority of PIC/S member and located outside of countries of PIC/S members the time required to obtain the conclusion on recognition of GMP certificate is approximately 3 months after the submission of the dossier.

For manufacturing sites that do not have GMP certificate issued by the competent authority of PIC/S member the time required to obtain a certificate is from about 4 to 7 months after the submission of the dossier.

The validity term of the certificate is three years from the date of the end of the inspection.

The validity term of the conclusion may not exceed the term of recognized GMP certificate issued by the competent authority of PIC/S member, but it may be extended to 6 months in case of timely submission of information about the dates settled for new inspection to be conducted by the competent authority of PIC/S member.

In order we could provide you with the information on costs associated with GMP conformity assessment in Ukraine together with the detailed information required from your side, sample of the Power of Attorney for execution, etc. please contact our specialists.

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