Mikhailyuk, Sorokolat & Partners

Patent and Trademark Attorneys

GMP conformity assessment in Ukraine

For the State registration of medicinal products

Patent Ukraine In accordance with the Decree of the Cabinet of Ministers of Ukraine No. 376 dated May 26, 2005, compliance of production of medicinal products with Good Manufacturing Practice requirements shall be checked during examination of registration materials submitted for state registration (re-registration).


Required documents

The procedure of examination of documents on GMP conformity assessment is conducted by the State Service of Ukraine on Medicines and Drugs Control (SMDC) and is free of charge. For initiating the procedure of GMP conformity assessment it is necessary to provide to the SMDC an application for issuance of the certificate or conclusion on confirmation of compliance of medicinal products manufacture conditions with GMP requirements together with the following documents:

  • legalized Power of Attorney from the applicant to the representative;
  • copy of an application for state registration (re-registration) of the medicinal product that has been submitted to the State Expert Centre of the Ministry of Health of Ukraine (if available);
  • legalized copies of Manufacturer's Authorizations for all manufacturing sites involved in manufacturing process and issued by competent authorities of countries-manufacturers, or their printouts from the official database;
  • legalized copies of official documents issued by 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 EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine or their printouts from the official database;
  • certified copies of dossiers of the manufacturing sites;
  • Site Master Files (for manufacturing sites located in countries other than the EU member states, the Great Britain or the countries that have a mutual recognition agreement with the EU or with Ukraine);
  • certified copies of the latest reports on inspections of the manufacturing sites by competent authorities of the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine that were conducted within 3 years before submission of the application (for manufacturing sites located in countries other than the EU member states, the Great Britain or the countries that have a mutual recognition agreement with the EU or with Ukraine);
  • certificate on the quality of the medicinal products that are registered in Ukraine or have been submitted for state registration (re-registration);
  • certificate on the results of all inspections conducted by the competent authorities within 3 years before the date of submission of the application for issuance of the certificate or conclusion;
  • general list of medicinal products that are registered in Ukraine and/or have been submitted for state registration (re-registration);
  • certified copies of certificates of a pharmaceutical product (free sale certificates) issued by competent authorities of country of applicant/manufacturer or by other regulatory bodies from the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine and where said products are marketed (for medicinal products not registered in Ukraine), etc.;
  • copies of Marketing Authorizations issued for the medicinal products by competent authorities of the EU, the Great Britain, or countries that have a mutual recognition agreement with the EU or with Ukraine that have issued GMP Certificate for manufacturing site responsible for batch release (in case any manufacturing stage of the medicinal product is carried out outside the aforementioned countries).

Procedure

Procedure of GMP conformity assessment includes the following steps:

  • submission of the application and documents to obtain a certificate or conclusion;
  • inspection of manufacturing sites (if required);
  • receipt of a certificate or conclusion of compliance to the GMP requirements and/or report on compliance or non-compliance to the GMP requirements.

According to the Order No. 1130 "On approval of the Procedure for conducting confirmation of the conformity of manufacturing conditions of medicinal products with the Good Manufacturing Practice requirements" of December 27, 2012 with the last amendments of July 21, 2020, for manufacturing sites that have a GMP certificate issued by a competent authority of the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine (the USA, Canada, Switzerland, New Zealand, Australia, Japan and Israel), GMP conformity assessment is carried out only by examination of provided documents, while for manufacturing sites that do not have a GMP certificate issued by a competent authority of the above-mentioned countries, GMP conformity assessment is made both by examination of provided documents and conducting of mandatory inspection of the manufacturing site with departure to the plant.

In case any manufacturing stage of the medicinal product is carried out outside the EU, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine, copies of Marketing Authorizations issued by a competent authority of one of these countries that has issued GMP Certificate for manufacturing site responsible for batch release have to be provided for the recognition procedure in Ukraine. In case of absence of the above-mentioned Marketing Authorization, the manufacturing site shall be inspected for compliance with GMP requirements by Ukrainian authorities.


Possible remote inspection

It should be noted that the latest amendments into the Order No. 1130 of July 21, 2020 caused by the worldwide outbreak of COVID-19 allow for conducting the above-mentioned inspection remotely under certain circumstances. In particular, in times of national or global crisis caused by Coronavirus where travel is restricted or prohibited the Order now provides for the possibility of a remote inspection service for the purpose of further issuance of a GMP certificate on the basis of a documented survey of the manufacturer. Other situations stipulated by the Order that presuppose the possibility of remote inspection, except for pandemic, are state of emergency, state of war and natural disasters. Remote inspection allows for leveraging modern communication technologies such as video-/teleconferencing by means of giving access to the manufacturing site/laboratories/warehouses (including those under contract), production documentation and quality system documentation for compliance with GMP requirements. The decision to issue a GMP certificate shall be based on a report reflecting the results of such remote inspection.

Remote inspection may supersede the site inspection only once and is possible only if the manufacturing site had already been inspected in the past by the Ukrainian authority or competent authorities of the EU member states, the Great Britain or countries that have a mutual recognition agreement with the EU or with Ukraine.


Timeframe

The timeframe for obtaining a GMP Certificate in Ukraine is from about 4 to 7 months after submission of the dossier. The procedure of obtaining the conclusion on recognition of a GMP certificate where no inspection of the manufacturing site is required takes approximately 3 months after submission of the dossier.


Validity term

Validity term of the certificate is three years from the date of the end of the inspection or two years from the date of the end of remote inspection.

Validity term of the conclusion may not exceed the term of the recognized GMP certificate issued by a competent authority of one of the EU member states, the Great Britain or a country that has a mutual recognition agreement with the EU or with Ukraine. Nevertheless, it may be extended for 6 months in case of timely submission of information about the dates settled for new inspection to be conducted by the aforesaid competent authority.

For more detailed information, including the costs associated with GMP conformity assessment in Ukraine, list of documents required for submission, as well as a sample of the Power of Attorney for execution, etc. please contact our specialists.


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