Ukraine has introduced new, easier regulation for GMP compliance confirmation. These procedural improvements are brought about by the recently adopted Ministry of Health Order No 452.
The EBA Health Care Committee – the largest and one of the most influential platforms uniting leading pharmaceutical and medical product companies in Ukraine – welcomes easier GMP compliance confirmation in Ukraine.
What is GMP?
GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.
Mostly, international manufacturers have GMP certificates issued by PIC/S participating authorities.
To register a medicine in Ukraine the manufacturer has to obtain a GMP Conclusion issued by an authorized local body – the State Agency of Ukraine on Medicinal Products.
GMP conclusion: simplified procedure
The Ministry of Health’s Order No 452 introduces several procedural improvements into the process of GMP compliance confirmation that are worth mentioning, inter alia:
- The period for GMP compliance confirmation is almost halved, to 15 days (if the medicine is already registered by the European Medicines’ Agency (EMA)).
- Different applicants can use the same Ukrainian GMP Conclusion.
- Document certification requirements are simplified. Now it’s easier to compile the whole package of documents required for GMP Conclusion.
The European Business Association welcomes these improvements and hopes to see their correct practical usage. These improvements, if properly applied, will reduce the operating costs for GMP confirmation – both for business and the state (the State Agency of Ukraine on Medicinal Products).
We thank all members of the EBA Health Care Committee for their contribution and involvement.
The EBA Health Care Committee highlights that Ukraine shall finally recognize GMP certificates issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) authorized bodies as the next deregulation step forward. This progressive step will require amendments to the Law of Ukraine “On Medicines”.
The Ministry of Health of Ukraine’s Order “On Amending the Regulation On the Medical Drugs’ Compliance with the Requirements to the Good Manufacturing Practices” No.452 dated 22 July 2015 was made effective on 18 September 2015 via official publication.
The Ministry of Health of Ukraine’s Order No.452 introduced a number of procedural improvements during the procedure of the GMP compliance confirmation in Ukraine.