Permission for import of medicine/medical products, equipment and their registration in the RK

According to the Order of the Minister of Health of the Republic of Kazakhstan dated November 18, 2009, No. 735 “On approval of the Rules of state registration, re-registration and amendments to the registration dossier of a medicinal product, medical devices and medical equipment”, it is mandatory to be included in the State Register registered and approved for medical use in the Republic of Kazakhstan:

• medicines;
• drug substances;
• bulk products;
• medical products;
• crude medicine of natural origin (including medicinal plants);
• parapharmaceutical products;
• homoeopathic medicines.
• medical equipment;
• medical immunobiological preparations.

Registration can be done only after an expertise consisting of 2 or 3 stages:​

1. Verification of documents that are provided and allow the consideration of the drug as orphan.
2. Verification and processing of methods aimed at quality control of the drug and direct control in accordance with these methods.
3. Establishment of the ratio of the expected benefit of the drug and possible risks of its action.

A separate registration dossier is filed for each drug. Within the same dossier, a simultaneous examination of one medicine in different dosages, volumes and concentrations is allowed.

 EXPERT Entrepreneurs Service Center provides the following services:

• Consultation on registration of medical devices and equipment.
• Creation, collection and maintenance of registration dossiers as required.
• Drawing up a list of documents.
• Production of certain documents for registration.
• Adaptation of documents provided by the partner / client in accordance with the law of the Republic of Kazakhstan.
• Creating a layout of primary and secondary packaging.
• Submission of the dossier to the responsible authority that conducts state registration of medicines, equipment and other products.
• Kinetics and dissolution test.
• Conducting and monitoring various preclinical and clinical studies of the drug.
• Arranging for formal inquiries, permits and decisions.
• Preparation and collection of additional materials.
• Obtaining a Registration Certificate and agreed documents for a medical device.
• Conducting confirmation of state registration or re-registration of drugs.
• Amending the registration dossier in accordance with the requirements.
• Registration of dietary supplements and materials for its manufacture.
• Entering pharmaceutical substances into the State Register of the Republic of Kazakhstan.