Article 18. Manufacture of medicines and medical products
On amendments and additions to the law of the Republic of Uzbekistan "On medicinal products and pharmaceutical activity" (LRU-399-son) · Date: 04.01.2016 · In force
Manufacture of medicines and medical products shall consist of serial production in accordance with the rules for organizing their manufacture and quality control, and shall include production under a full technological cycle or by separate stages thereof.
It shall be prohibited to manufacture counterfeit medicines and medical products, medicines and medical products not registered in the Republic of Uzbekistan, as well as illegal copies of medicines registered in the Republic of Uzbekistan.
Manufacture of medicines and medical products may be carried out under contract by other manufacturers holding the appropriate license, in accordance with the order of a manufacturer of medicines and medical products. In such case, the certificate of state registration for the medicines and medical products shall be issued to the organization that directly manufactures the medicines and medical products under the order.
Manufacture of medicines and medical products intended for state registration, export, research and development, preclinical studies, and clinical trials may be carried out without their state registration.
Manufacturers of medicines and medical products must have internal departmental services responsible for quality control of medicines and medical products.
The rules for labeling and packaging of medicines and medical products shall be approved by the Ministry of Health of the Republic of Uzbekistan.
