01
Laws and regulations governing the process of registration of dietary supplements:
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;
Order of the Ministry of Health No. 26 dated 08 May 2009 “On the Procedure for Assigning Studies with Regard to Evaluating the Effectiveness and Carrying Out Clinical Trials of Dietary Supplements”;
Resolution of the Chief State Sanitary Doctor No. 1 dated 04 February 2009 “Procedure for Issuing a Permit Letter for Imported (Foreign Production) Dietary Supplements in the Republic of Uzbekistan”.
The following products are subject to registration:
- Vitamins
- Minerals
- Amino acids;
- Bodybuilding supplements and sports nutrition products
- Essential fatty acids
- Probiotics;
- Natural dietary supplements
- Immunomodulators
- Dietary fibre
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Registration stages:
01
Preparation of the registration dossier, collection of all necessary documents
02
Preliminary analysis of the registration dossier, evaluation of the collected package of documents and making adjustments, if necessary
03
Submission of an application for the procedure, submission of an application to the state body for preparation of an agreement and carrying out the primary expert examination of the documents
04
Primary expert examination of the documents, analysis of the documents of the registration dossier with the issuance of an opinion based on the results of the primary expert examination
05
Inspection of production (if necessary), for dietary supplements undergoing the registration procedure at the first declared production site
06
Sanitary and hygiene and technical tests*, testing with the provision of samples for testing and the issuance of the results of acts of hygiene expert examination
07
Clinical trials or clinical evaluation, evaluation or trials of dietary supplements in clinics
08
Specialised expert examination of the registration dossier and the test results with the execution of the order of the Ministry of Health of the Republic of Uzbekistan with regard to the decision to register dietary supplements
09
Issuance of the registration certificate, with the placement of information on registration (re-registration) in the State Register of the Ministry of Health of the Republic of Uzbekistan
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