Registration of medicinal products Uzbekistan
During state registration (re-registration) and making changes to the registration dossier in the Republic of Uzbekistan, medicinal products undergo procedures for confirming their quality, safety, and efficacy.
Laws and regulations governing the process of registration of medicinal products:
Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 213 “On Approval of the Regulations on the Procedure for State Registration of Medicines, Medical Devices, and Medical Equipment and the Issuance of a Registration Certificate” dated 23 March 2019.
State bodies (hereinafter referred to as “SB”) participating in the process of registration of medicinal products:
State Unitary Enterprise State Centre for Expert Examination and Standardisation of Medicines, Medical Devices, and Medical Equipment of the State Unitary Enterprise of the Agency on Development of Pharmaceutical Industry under the Ministry of Health of the Republic of Uzbekistan (hereinafter referred to as the “SCEEaS”).
Expert examination period (in the state body): 155 days.
Registration certificate (hereinafter referred to as the “RC”) validity period: 5 years.
The following products are subject to state registration:
- Medicinal products
- New combinations of medicinal products registered in the Republic of Uzbekistan
- Medicinal products previously registered in the Republic of Uzbekistan, but produced in other dosage forms, dosages or by another manufacturer
- Medical products
- Medical equipment