Recognition of documents issued by the regulatory authorities of the European Economic Area countries and Great Britain regarding medicinal products manufacture

The guidance “Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic” has been developed jointly by the European Commission, the Coordination group for Mutual recognition and Decentralised procedures – human (“CMDh”) and the European Medicines Agency (“EMA”). Part 2.2 of the Guidance provide information on maintainance of the validity of current GMP certificates and authorisations to manufacture/import of medicinal products issued by the regulatory authorities of the European Economic Area countries and Great Britain.

According to the Order of the Ministry of Health of Ukraine No. 1130 as of 27.12.2012 “On approval of the procedure of confirmation of manufacturing conditions of medicinal products to the requirements of the good manufacturing practice” (hereinafter - Procedure) the State Service of Ukraine on Medicines and Drugs Control issues conclusions on confirmation on correspondence of conditions of medicinal products manufacture with the GMP requirements. The conclusion confirms that the GMP certificate issued by the authority of the PIC/S member country is considered as one that confirms correspondence of the conditions of medicinal products manufacture valid in Ukraine to the GMP requirements and is issued for the GMP certificate validity period. According to the Procedure, the information available in the EU's EudraGMDP database on a status of GMP certificate’s and license’s validity to carry on economic activities on manufacture of medicinal products is taken into account.

The applicant (applicant’s representative) may request the State Service of Ukraine on Medicines and Drugs Control sending written application to take into account the GMP certificate validity period which is confirmed in accordance with the Procedure and which was valid at the moment when the COVID-19 pandemic was declared. It is also neccesary to mention the number of conclusion and manufacrurer’s name to make amendments to the order of the State Service of Ukraine on Medicines and Drugs Control that confirms the desicion on its issuance and to reissue the conclusion.

While considering the application for issuance of the GMP certificate or conclusion, according to the Proсedure, the State Service of Ukraine on Medicines and Drugs Control takes into account the information available in the EU's EudraGMDP database on a status of GMP certificate’s and license’s validity to carry on economic activities on manufacture of medicinal products and there is no need for the applicant (applicant’s representative) to provide additional documents.