Ukraine. Drug manufacturing: Certification

Certification of drug manufacturing (hereinafter – certification) as to compliance with requirements of good manufacturing practice (hereinafter – GMP), including acceptance of GMP certificates, shall be introduced in order to create conditions for export of domestic drugs, improve and guarantee drug quality according to world standards, prevent circulation of poor quality drugs in Ukraine by means of confirmation of compliance of drug manufacturing with GMP requirements valid in Ukraine. Certification, including acceptance of GMP certificates, shall be carried out on voluntary basis.

The certification shall be carried out by the State Drug Inspectorate; expert examination can be carried out under participation of specialists of enterprises, institutions and organizations.

The certification procedure shall be determined pursuant to the Decree of the MHC of Ukraine dd. 30.10.2002 #391 «On approval of Drug manufacturing certification procedure».

According to the Procedure certification is carried out in respect to the whole production and single manufacturing sites. In order to certify «in bulk» officinal drug manufacturing production of all «in bulk» products used for manufacturing of such drugs shall have GMP certificate issued or accepted pursuant to the Procedure. Certificates can be accepted (the State Drug Inspectorate confirms the compliance of certified foreign drug production with GMP requirements effective in Ukraine) without inspection in following cases:

• if certified manufacturing is located in country – party to the international Pharmaceutical Inspection Co-operation Scheme (PIC/S), in USA or Japan or if manufacturing site is own foreign subdivision of a company with main manufacturing located in said countries (provided document confirming compliance of this site with GMP requirements issued by respective authority of the state where the main manufacturing is located and a report on last inspection of such site carried out by this authority); 
• if there is condition on mutual recognition of GMP requirements and inspection procedures between the State Drug Inspectorate and a respective authority of the state where manufacturing subject of the application is located. 

The validity term of certificate is not more than 2 years as of decision making on its issuance (for productions certified pursuant to the Procedure for the first time) or 5 years (for productions certified not for the first time) and cannot exceed the validity term of the drug manufacturing license. The decision on acceptance of the GMP certificate is valid for not more than 5 years and cannot remain valid after expiration of the validity term of the certificate being accepted.

Manufacturing verified pursuant to this Procedure is subject to scheduled and unscheduled inspections as to adherence to GMP requirements within the certificate validity term.