On June 30, Arnur Nurtayev, the representative of the Ministry of Health of the Republic of Kazakhstan, presented the Concept of the draft Law of the Republic of Kazakhstan “On Changes and Amendments to Certain Legislative Acts of the Republic of Kazakhstan on the Issues of Circulation of Medicines and Medical Devices.”
Nurtayev noted that the development of domestic pharmaceutical manufacturing is a priority objective of Densaulyk State Healthcare Development Program for 2016-2019. To achieve this objective, it is necessary to create an environment that facilitates the development of domestic manufacturing and minimize eventual legal and bureaucratic hurdles. In this regard, it is proposed to establish by law the priority treatment of manufacturers of medicines and medical devices of the Republic of Kazakhstan during the expert examination for the purposes of state registration, re-registration and changes to the registration dossier. This amendment will allow to speed up the market launch of domestic medicines and medical devices within and outside the Republic of Kazakhstan.
A prerequisite for the entry of medicines manufactured in Kazakhstan to EAEU common market is the compliance of manufacturing process to GMP requirements. In view of this, the acts of EAEU defined a number of measures required for implementation in the national legislation.
For example, in order to establish a common EAEU Register of Qualified Persons, EAEU defined the need to have a certified Qualified Person. To this end, it is necessary to introduce a rule on certification of Qualified Persons and plan the establishment and maintenance of relevant register. Also, as part of measures to create a common EAEU market, it is necessary to make clarifications in terms of the contract manufacturing and status of medicines manufactured under a contract.