According to the current laws of Ukraine, an integral part of the process of registration and provision of import of medicinal products to Ukraine is provision of a document to confirm compliance of the medicines manufacturing conditions with GMP:
Conclusion on recognition of GMP certificates issued by the competent authorities member countries of EU, Great Britain, or the countries having a mutual recognition agreement with EU or Ukraine
or
Certificate of compliance of medicines manufacturing conditions with GMP.
Issue of conclusions or certificates is made by the central executive authority – State Service of Ukraine on Medicines and Drugs Control (hereinafter referred to as the Derzhliksluzhba of Ukraine) – according to the Procedure of Confirmation of Compliance of Medicines Manufacturing Conditions with the Good Manufacturing Practice, approved by Order of the Ministry of Health of Ukraine of 27.12.2012 No. 1130 (hereinafter referred to as the Procedure) and developed in consideration of the requirements of Directive 2001/83/EC of the European Parliament.
Confirmation of compliance of medicines manufacturing conditions to the GMP in force in Ukraine is introduced in order to prove that medicinal products are always manufactured and controlled according to the quality standards meeting their intended purpose, and according to the requirements of a registration dossier, dossier of the investigational medicinal product for clinical trials or specification for this product.