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On Amendments to the Order of the Minister of Health and Social Development of the Republic of Kazakhstan “On Approval of the Rules for Assessing the Safety and Quality of Medicinal Products and Medical Products Registered in the Republic of Kazakhstan”

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On Amendments to the Order of the Minister of Health and Social Development of the Republic of Kazakhstan  “On Approval of the Rules for Assessing the Safety and Quality of Medicinal Products and Medical Products Registered in the Republic of Kazakhstan”

We inform you that as of June 6, 2019, amendments to the Rules for the Evaluation of the Safety and Quality of Medicinal Products and Medical Products Registered in the Republic of Kazakhstan come into force, approved by Order No. 269 of the Minister of Health and Social Development of the Republic of Kazakhstan dated November 26, 2014 .

An important change is that medical devices, which are devices, instruments, equipment, produced in conditions that meet the requirements of the international standard ISO 13485, will also be subject to a Safety and Quality Assessment by means of a declaration.

Safety and quality assessment of products is carried out in one of the following ways:

  1. serial assessment of the safety and quality of medicines manufactured under conditions that meet the requirements of the Standard of Good Manufacturing Practice (GMP) approved in accordance with sub-clause 115) of clause 1 of Article 7 of the Code and medical devices manufactured under conditions that meet the requirements of international standard ISO 13485 or GMP ;
  2. assessment of the safety and quality of each series (batch) of products;
  3. declaring the safety and quality of drugs produced under conditions that meet the requirements of the GMP of the Republic of Kazakhstan or GMP of the Eurasian Economic Union or the requirements of the countries of the region of the International Conference on Harmonization of Technical Requirements for Registration of Drugs for Medical Use (ICH), which is a state regulator which are part of the founders and permanent members of the ICH (European Union countries, the United States of America, Japan, Switzerland , Canada), imported medical devices manufactured in conditions that meet the requirements of the ISO 13485 international standard OECD and / or EN ISO 13485 certificates issued by an accredited organization of one of the countries of the Organization for Economic Cooperation and Development for foreign manufacturers, or GMP ICH, for domestic manufacturers medical devices and medical devices, which are devices, devices, equipment of the international standard ISO 13485.

We would like to remind you that the safety and quality assessment of products is carried out with the aim of:

  1. confirmation of the safety and quality of products in the post-registration period;
  2. confirmation of the safety and quality of products withdrawn from the market by a government agency for claims for quality products;
  3. confirmation of the safety and quality of products withdrawn from the market by a government agency, taking into account the risk-based approach;
  4. confirmation of the safety and quality of products based on the results of pharmacovigilance of medicines and monitoring of the safety, efficacy and quality of medical devices;
  5. prevent the circulation of counterfeit products on the market of the Republic of Kazakhstan.

The applicant independently chooses the method of conducting a safety and quality assessment of products.

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