Ukraine. Technical regulations will come into force on 1 July 2014

Technical regulations for medical products (hereinafter – Technical Regulations) approved by Order of CMU № 536 dated 11 June 2008, № 621 dated 9 July 2008, № 641 dated 16 July 2008, firstly were to come into force on 1 January 2013.

However, the MHU Order № 1498/1126 dated 27 December 2012 “On the approval of amendments to certain orders of the State Committee of Ukraine on Technical Regulation and Consumer Policy and the Ministry of Health of Ukraine” was published on the web-site of MHU. According to this order the introduction of technical regulations is postponed till 1 July 2014 with the purpose of performing any necessary changes.

Absence of the adoption of harmonized standards and formal conformity assessment procedures and its simplification for medical products that have passed the registration procedure resulted in the situation where the companies were deprived of the adequate conditions for the application of the procedure and marking its medicines with the national mark on conformity. Thus, the introduction of these changes will have a positive influence on the conduct of business environment.

Source: KPMG Ukraine