National Center for Expertise of Medicines and Medical Devices of the Committee for Quality Control and Safety of Goods and Services of the Ministry of Health of the Republic of Kazakhstan approved new standard contract templates:
- for the translation services of the SmPC and PIL (package insert), layouts of the packaging to the state language;
- for the translation services of instructions for use of a medical device, layouts of packaging to the state language;
- for the evaluation of a medicinal product within the framework of the Eurasian Economic Union on the territory of the Republic of Kazakhstan within the the mutual recognition procedure/or decentralized procedure.
To conclude a contract, filled draft of the contract should be sent to the firstname.lastname@example.org supplemented with the following docs:
for translation services:
- a certificate of the state registration of a legal entity in Kazakh and Russian languages issued in the current month;
- a power of attorney to sign the contract if the contract is signed by an authorized person.
for evaluation services:
- application form according to the the Rules for the registration and examination of medicines for medical use, approved by Decision of the Council of the Eurasian Economic Commission No. 78 of November 3, 2016;
- documents confirming registration as a legal entity;
- power of attorney for authorised representative.
Templates of the contracts are available on the official website.