REGISTRATION AND RE-REGISTRATION OF MEDICAL PRODUCTS (MEDICINES) IN THE KYRGYZ REPUBLIC
The health is depending on the quality of used drug to a large extent. Before selling any medical product must have passed marketing authorization and receive approval for sale in according to the decision of Government of Kyrgyz Republic in agreement of Law No. 91 from 04/30/2003 “Medicines” and Regulation “Safety of medical products” to providing of safe application and effectiveness of medical products.
Foreign medical products are subject to obligatory authorization in the country of origin.
Reg Med Service provides a wide range of services for initial registration and re-registration of medical products in the Kyrgyz Republic.
What we offer:
- Performing of complete cycle of registration/re-registration of medical products in Kyrgyzstan;
- Strict assurance at every stage: from preliminary preparation of registration dossier to obtaining of Certificate of Marketing Authorization;
- Altering and approving of necessary corrections in registration dossier of medicines;
- Representing of your favor in government bodies;
- Counseling for all considerations associated with marketing authorization;
- Preparation and compilation of set of documentation necessary for marketing authorization procedure;
- Professional technical translation of authorization documentation;
- Design services for development of primary and secondary package mock-up;
- Compilation of single documents for dossier (leaflet, label).
FOLLOWING PERTAIN OBLIGATORY MARKETING AUTHORIZATION:
- New medical products.
- Medical product that previously had marketing authorization but having:
- New formulation;
- Changed dosage;
- New combination of active ingredients;
- Changed composition of excipients;
- Homeopathic medicines;
- Immunobiology medical products;
- Generic medical products.