Effective July 1, 2022, the mandatory certification of medicines, medical devices and medical equipment of local production will be replaced with post-marketing surveillance. The local pharmaceutical regulator, the Pharmaceutical Industry Development Agency of Uzbekistan, published for public consultation the draft procedure for post-marketing surveillance. The draft is available in Uzbek here.

Is it relevant for my business?

It is relevant if you manufacture, or plan to manufacture, medicines, medical devices or medical equipment in Uzbekistan.

What is expected to change?

From July 1, 2022 the currently effective mandatory certification of medicines, medical devices and medical equipment produced in Uzbekistan will be replaced with post-marketing surveillance.

To be eligible for the new certification exemption, local manufacturers of pharmaceuticals must hold a locally issued GMP certificate; manufacturers of medical devices and medical equipment must have the ISO:13485 certificate.

The local regulator has overall responsibility for the post-marketing surveillance and will purchase/obtain a product sample for testing, issuing its decision based on the test results. If the test results reveal non-compliance with regulatory requirements, this could trigger a number remedial actions from the regulator, including a more extensive audit and a suspension of the manufacturing and sale license, or cancellation of GMP/ ISO:13485 certificates.

What should you do next?

The new regime can shorten the time required to launch a new manufacturing capacity or a new product in Uzbekistan. We expect the draft procedure on post-marketing surveillance to be adopted by July 1, 2022. Hence, businesses may want to start preparing now for the new regime, and should be ready to expect some “frictional challenges” until the local practice of post-market surveillance develops.

Should you wish to learn more about launching a new manufacturing capacity or product in Uzbekistan, please feel free to reach out to us.