Uzbekistan defines procedure for certification of pharmaceutical products

The Minister of Health of the Republic of Uzbekistan adopted the Order “On Approval of the Rules for Certification of Pharmaceutical Products” under the registration No. 3386 dated September 12, 2022.

In accordance with the Rules for Certification of Pharmaceutical Products:

  • certification of pharmaceutical products is carried out by accredited certification bodies;
  • certification is carried out after the state registration of pharmaceutical products;
  • in the absence of relevant instructions for certification tests in international standards, organization standards, technical regulations, the State Pharmacopoeia, pharmacopoeial articles (hereinafter referred to as the "Standards"), the certification body focuses on the quality and safety indicators specified in international standards in the field of control for the quality of pharmaceutical products;
  • in the absence of Standards for imported pharmaceutical products, certification tests are carried out on the basis of requirements for similar products;
  • in the absence of a testing center (laboratory) for testing foreign pharmaceutical products, certification is carried out by identification.

Certification is carried out by submitting an application and the necessary documents to the certification body in electronic form through the “Single Window” system of the State Customs Committee of the Republic of Uzbekistan. The decision to conduct or refuse to conduct certification is made within 2 (two) days.

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