Expertise of medicines

In accordance with Articles 63 and 71 of the Code of the Republic of Kazakhstan dated 18 September 2009 "On people's health and the health care system" and to improve the procedure of state registration of drugs changes to the legislation in the field of drug registration are made.

State registration and re-registration apply to medicines produced in the Republic of Kazakhstan, as well as to medicines imported into its territory which are registered in the country of origin, including:

• Medicines under trade names with stated dosage form, dose, packaging;
• Bulk products, entering the Republic of Kazakhstan;
• New combinations of medicines which were earlier registered in the Republic of Kazakhstan with stated dosage form, dose, packaging;
• Medicines which were earlier registered in the Republic of Kazakhstan, but produced by other manufacturers in different dosage forms with new dosage, new packaging, different composition of excipients, under different names.

State registration does not apply to:

• Medicines prepared in pharmacies;
• Pharmaceutical ingredients produced in compliance with GMP requirements.

State registration, re-registration and amendments to registration dossier is implemented by public authority in the field of medicines, medical devices and medical equipment (hereinafter - the Committee or the State agency).

The Expertise of Medicines is implemented by state expert organization in the field of medicines, medical devices and medical equipment, which is not involved in drug design and manufacture of medicines (hereinafter NCED or Expert organization) in compliance with a contract with the applicant.

The Expertise of the medicine during state registration, re-registration and amendments to the registration dossier In accordance with the order of the Minister of health and social development of the Republic of Kazakhstan dated November 18, 2009 № 735 "On Approval of Rules of the state registration, re-registration and amendments to registration dossier of medicines, medical devices and the medical equipment", consists of the following steps:

1. Primary expertise;
2. Analytical expertise;
3. Specialized pharmaceutical expertise;
4. Specialized pharmacological expertise;
5. Safety, efficacy and quality confirmation.

Each next step of the expertise of medicine is carried out after positive inference on the preceding step of the expertise of medicine.

Procedure and terms of the expertise of medicines are set by order of the Minister of health and social development of the Republic of Kazakhstan dated November 18, 2009 № 736 and In accordance with it the expert organization during the expertise of medicines may request from applicant an explanation or clarification on specific provisions provided in the documents and materials.

If the requested materials or written grounds for another deadline, but not exceeding sixty calendar days are not provided by applicant, Expert organization ceases the process of registration and informs public authority and applicant about its decision within 10 days.

Public authority makes decision on the registration, re-registration and amendments to the registration dossier of medicine, or refusal - on the advice of an expert organization on safety, efficacy and quality of drugs.

In the case of a positive decision on the state registration, re-registration of the drug, state body issues an order, approves and issues the applicant:               

• a registration certificate to the registered drug with an indication of the period within which the medical use is allowed in the Republic of Kazakhstan;
• approved instructions for medical use of the drug in state and Russian languages;
• agreed specifications of quality and safety of the medicine with the assigned number;
• approved package, labels, stickers.