The medical products are considered as goods that have the highest level of risk. The degree of evaluation and regulation to which they are exposed is strict and detailed, and manufacturers must provide comprehensive data on the safety, quality, and effectiveness of the medicinal products. Manufacturers often faced to difficulties with the registration of medicines in the Kyrgyz Republic and with whom to entrust legal support for registration.
Reg Med Service provides three key directions of action: safety, quality, effectiveness.
We provide the following services:
- Registration of medical products in the Kyrgyz Republic
- Translation of medical documentation
- Registration and reregistration of dietary supplements
- Customs clearance of medicinal products in Kyrgyzstan
- Registration of veterinary medicinal products
- Registration of medical devices in Kyrgyzstan
List of documents that required for registration of medicines in Kyrgyzstan:
- Documents for registration
- Summary of product characteristic:
- Making of license
- Registration in other countries
- Certificate of GMP
- Certificate of free trading
- Complete composition of the product (including active ingredients and excipients)
- Technical requirements of final products and assessment method for final products
- Pharmacological and toxicological documentation (dose toxicity, effects on reproductive potential, embryotoxicity data, pharmacokinetic and pharmacodynamic data, carcinogenicity data)
- Clinical data
- Bioequivalence report
- Package design with the Russian language
- Sample of product (6 items) with analysis certificate
- Sample of active ingredients with analysis certificate
Supplement registration procedure includes the following points:
- Sanitary-hygienic assay
- Granting of marketing authorization number;
For the import of pharmaceutical products, some of the above documents are required, as well as a certificate of origin issued by the required authorized bodies in the exporting country. A certificate of origin helps to determine the origin of imported goods. In some cases, on the basis of agreements between Kyrgyzstan and some countries, exemption from import duties and taxes can be obtained, which will help to reduce the cost of goods.
Reg Med Service company will help you to complete a full list of documents, to compose them correctly with the help of lawyers, if necessary, to prepare legally certified translations of documents and agrees to accompany you at all stages of registration and preparation of documents.