Changes Have Been Introduced into Registration (Re-Registration) Procedures of Medical Products that May Be Procured through International Organizations

Cabinet of Ministers of Ukraine has adopted the Resolution № 597 from August 12, 2015 «On Amendments Introduction into Cabinet of Ministers of Ukraine Resolution №376 from May 26, 2005», which adjusts the current Resolution of Cabinet of Ministers №376 from 26.05.2005 «On Approval of State Registration (Re-registration) Procedures for Medical Products and their Registration (Re-registration) Duty Amount».

The relative amendments foresee that state registration of medical products procured through specialized international organizations should be conducted on the basis of a claim letter and a conclusion of State Enterprise «State Center for Drug Evaluation and Research of Ministry of Health of Ukraine» made according to the expert studies of registration materials regarding their authenticity.

Together with the state registration claim letter there should be provided the following:

1. Materials of Registration Dossier submitted for product registration to the state regulatory agency within which the specified medical product has been registered or for its requalification by World Health Organization;
2. The Evaluation Report of the specified product developed by the state regulatory agency which registered this product or issued by World Health Organization in case the medical product is requalified;
3. Quality control methods of the medical product;
4. Instruction for use of the medical product or information on application of the medical product;
5. Sample of original packaging of the product;
6. Ukrainian translation of the texts of medical product package labeling and instruction of use of the medical product.

The designated reason for rejection of state registration of the medical product which falls under procurement through international organizations is the failure to submit the abovementioned materials or submission of the low volume package of materials, revelation of unreliable or incomplete information within the submitted documents, recognition of the translation of the medical product package labeling or the instruction of its application to be not authentic.

The decision on registration of such products the Ministry of Health of Ukraine shall make during the period of 7 working days. The validity of registration certificates may last up to March 31, 2019. State registration duty for the specified products shall not be accounted.