Research Centre for Standardization of medicinal forms
Services of the Scientific Center for Standardization of Medicines
– development of draft NTDs for new medicines;
– Preparation of a package of documents for registration of a medicinal product in the Ministry of Health of the Republic of Uzbekistan;
– approbation of methods for quality control of medicinal products;
– development of technology for obtaining medicines and food additives;
– development of new and improvement of existing methods of quality control of drugs;
– preclinical pharmaco-toxicological studies of new drugs;
– biopharmaceutical research (pharmacokinetics and pharmacodynamics);
– Certification of medicines and medical products;
– qualified services and advice on registration of applications for trademarks, inventions and industrial designs in the field of pharmaceuticals and medicine;
– development of standard samples of medicinal substances;
– scientific-methodical and patent-information services;
– refresher courses for analyst chemists using modern analysis methods (HPLC, GLC, etc.);
– analysis of biologically active additives and products of therapeutic nutrition;
– quality control of medicines;
– development of the design of medicine packages and translation of the texts of packages and instructions.
The procedure for certification of medicines
MF are subjected to sale in the territory of the Republic of Uzbekistan if there is a certificate of conformity issued in the name of the applicant within the NSS RUz, OSMP on drugs, accredited in accordance with the established procedure.
A certificate of conformity for a drug lot is issued for a period equal to the expiration date of the medicinal product established by regulatory documents.
The certification of drugs includes the following basic operations:
- a) application for certification;
- b) decision-making on the application, including selection of the certification scheme;
- c) identification, sampling and delivery to the laboratory;
- d) development of a test program
- e) testing of samples in an accredited laboratory (in IC or subcontracted);
- f) an assessment of the state of production of OSMP products (for certification schemes 3 and 4);
- g) product evaluation by the supplier, application for certification based on the declaration;
- h) Analysis of the results obtained and the decision to issue a certificate of conformity; (a positive result of the analysis is the basis for issuing a certificate of conformity)
- i) Issue of the certificate of conformity and the right to use the Sign of conformity confirmation (in accordance with the Law of the Republic of Uzbekistan “On certification of products and services”;
- j) Implementation of inspection control over the stability of certified product characteristics and the stability of production (depending on the certification scheme);
- k) Informing about the results of certification, by registering certificates in the State Register of the NSS and publishing the results of certification.
When certifying a batch of products, the following documents must be provided:
- a) Goods accompanying documents, with a note on the arrival of drugs in the customs territory of Uzbekistan (goods invoice, invoice or invoice);
- b) Data on labeling in accordance with legislation; (a sample of product labeling is given in the approved ND for products).
- c) Information on registration of drugs in the State Register of medicines and medical products of the Ministry of Health of the Republic of Uzbekistan; (if necessary).
- d) a copy of the ND for the declared products (if necessary).
- e) Document confirming the quality of products (quality certificate, passport).
