Uzbekistan Amends Pharmaceutical Licensing Regulation
A decree intended to accelerate the development of the pharmaceutical industry in Uzbekistan in 2019–2021 entered into force on August 17, 2019, after being signed by the Uzbek President on April 10, 2019.
According to amendments introduced by the decree, licenses for the production of pharmaceuticals are no longer granted by the Ministry of Health, but by the Agency for the Development of the Pharmaceutical Industry established under the same ministry. Previously issued licenses will be valid until their expiration date. Pharmaceutical retail trade is licensed through the Single Portal of Interactive State Services. The Ministry of Health delegated some of its other functions to the Agency as well, specifically the supervision of the production and wholesale of medicines and medical devices and the state regulation of the pharmaceutical industry, namely the registration, standardization, certification, and technical regulation of pharmaceutical products.
The decree has also introduced a temporary measure intended to give priority to local manufacturers in the public procurement of pharmaceuticals. Namely, from July 1, 2019 until December 31, 2020, when a state body issues a pharmaceutical tender, if there are two or more local manufacturers of pharmaceutical products of the same international nonproprietary name (INN), all tender applications filed by foreign manufacturers of products of the same INN will be refused. Further developments after December 31, 2020 will depend on the results of this temporary measure.
Registration renewal for medicines fully manufactured abroad and imported in Uzbekistan without being packaged, labeled and marked is now only possible in the absence of local pharmaceutical companies which supply sufficient volumes of similar products demanded in the domestic market.
From January 1, 2022, the following will be subject to mandatory certification in accordance with relevant quality standards:
- All preclinical pharmaceutical research laboratories will be subject to Good Laboratory Practice (GLP);
- All clinical research institutions under the Ministry of Health will be subject to Good Clinical Practice (GCP);
- All local manufacturers of medicines will be subject to Good Manufacturing Practice (GMP); and
- All enterprises engaged in wholesale distribution of medicines will be subject to Good Distribution Practice (GDP).
Finally, applications for registration of in vitro diagnostic products and medicines prequalified by the World Health Organization will be examined in an accelerated procedure not exceeding 60 days. In such cases clinical examinations will not be conducted. Requests for recording amendments in the registration documents will be considered within 30 days.
Prepared by: Gulnoza Abdurakhmonova and Djakhangir Aripov
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Source: Uzbek news and legal portal Norma.uz
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