According to the Law of the Kyrgyz Republic “On medicinal products”, import and sale of medicinal products in Kyrgyzstan are only allowed after state registration (renewal of registration).
Registration of medicinal products may be performed by the decision of Applicant either under the “national” procedure until 31 December 2020, or under the “uniform” EAEU procedure; and only under the “uniform” procedure of the EAEU after 31 December 2020.
Competent authority responsible for expert evaluation of registration materials for finished medicinal products is the Department of pharmaceutical supply and medical equipment of the Ministry of Health of the Kyrgyz Republic (website: http://www.pharm.kg/).
The procedure for national registration is described below. For description and requirements of the “centralized” EAEU procedure please follow the link.
National registration procedure
The procedure for national state registration of medicinal products was approved by Resolution of the Government of the Kyrgyz Republic No. 405 dated August 28, 2018. It is also necessary to take into account the provisions of Technical Regulation “On the safety of medicinal products for medical use”, approved by Resolution of the Government of the Kyrgyz Republic No. 137 dated April 6, 2011 (updated December 6, 2018).
The registration dossier is accepted in the CTD format. For a complete registration dossier, it is necessary to develop specific national documents:
- Application form;
- Normative document (ND) – regulatory document that includes the composition of the finished product, specification for release and shelf life, quality control methods, information on storage conditions, information on the manufacturers, etc.;
- Instructions for medical use (package insert);
- Color artworks (mock-ups) of the primary and secondary packaging.
Part of the documentation must be submitted with translation into Russian.
For orphan drugs, it is allowed to submit a summary of preclinical and clinical data, with a rationale for the benefit-risk ratio, instead of preclinical and clinical materials.
The registration dossier is submitted in electronic form, except:
- Module 1 (administrative data);
- Normative document (ND);
- Instructions for medical use of a medicinal product (package leaflet).
Module 1 must be submitted considering the requirements for international legalization of documents.
The package labeling is submitted and approved in Russian and/or Kyrgyz.
Instructions for medical use should be submitted and approved in Russian and Kyrgyz.
Stages of the registration procedure in brief:
- Filling the Application form and registration materials;
- Submission of the documentation and samples to the competent authority;
- Payment of the state fees;
- Expert evaluation (primary and secondary) of the registration materials;
- Answers on the deficiency letters, corrections and reconciliation of the text of the instructions, normative document and package labeling;
- Laboratory control of the samples;
- Positive conclusion of the specialized assessment;
- Ministry of Health issues the Order on state registration of the medicinal product;
- Registration certificate is granted to the MAH.
Laboratory quality control of finished product is required. MAH should provide samples and reference standards in quantity sufficient to perform QC in 3 parallels.
Timeline of the registration is 180 calendar days from submission of the Application and registration dossier. This period does not include the time necessary for the MAH to pay state fees, the duration of the laboratory analysis and the time for responses to questions (observations). In some cases, the inspection of the manufacturing site and quality assurance system is required.
Inspection of the manufacturing site
Inspection of the manufacturing site is carried out at the newly introduced manufacturing site, as well as in case of transfer of manufacturing technologies (for generic medicinal products).
Language and labeling
The package labeling is submitted and approved in Russian and/or Kyrgyz.
Instructions for medical use should be submitted in Russian, approved in Russian and Kyrgyz.
Kyrgyzstan is a country with high standards of regulation of marketed medicinal products. Inconsistencies between approved and actual packaging layouts, instructions for use, quality certificates may cause rejection of the medicinal product and temporary or permanent prohibition on sales.
The Registration Certificate
The Registration Certificate consists of several documents:
- Registration Certificate itself;
- Approved text of the instructions for medical use;
- Approved color artworks (mock-ups) of the primary and secondary packaging;
- Approved normative document on control of the quality of medicinal product.
The validity period of the Registration certificate is 5 years. The Registration Certificate is issued in the name of the Applicant (Marketing Authorization Holder) of the registration, which can be either a resident or non-resident of the Kyrgyz Republic.
Changes and variations
Variations to the Registration Certificate are performed on the basis of Resolution of the Government of the Kyrgyz Republic No. 137 on the approval of Technical Regulation “On the safety of medicinal products for medical use” dated April 6, 2011 and Procedure for state registration of medicinal products for medical use approved by Resolution of the Government of the Kyrgyz Republic No. 405 dated August 28, 2018.
The owner (Marketing Authorization Holder) of the Registration certificate for medicinal product is obliged to inform the competent state authority of any changes regarding the authorised medicinal product data submitted during registration, providing comprehensive information about the reasons for these changes and their possible impact on the efficacy, safety and quality of the medicinal product.
Changes that do not require new registration procedure:
- Change in the name without changing the composition;
- Change in the name of the manufacturer;
- Change in the legal address, details of the manufacturer or holder of the registration certificate without changing the manufacturing site;
- Change in the composition and quantity of excipients (except for components of vaccines and biological medicinal products) in order to improve the quality parameters of the medicinal product;
- Change in the qualitative composition of the primary (immediate) packaging of the medicinal product;
- Addition of new warning(s) or limitations of therapeutic indicators during the medical use of a medicinal product to the instruction for medical use;
- Change of the prescription status of the medicinal product;
- Addition or replacement of a measuring device for oral liquid dosage forms and other dosage forms of the medicinal product;
- Change of organization of the manufacturer(s) of the active substance, addition of a new manufacturer organization(s) of the active substance;
- Change of Normative document on quality of the medicinal product;
- Change in the shelf life of the medicinal product in relation to the period specified during registration;
- Change in the shelf life of the medicinal product after the packaging has been opened for the first time;
- Change of dimensions of tablets, capsules, suppositories or pessaries without change in qualitative composition of ingredients and mean mass;
- Changes in the manufacturing process for components requiring a test procedure for new impurities.
The period of specialized expert evaluation of the variations procedure is 60 business days, not including the time for responses to observations (deficiencies).
Renewal of registration (confirmation of registration)
The Application for renewal must be submitted no earlier than 180 calendar days before the expiration of the Registration Certificate validity, but no later than the last day of the Registration Certificate validity.
Medicinal products placed on the market of Kyrgyzstan within the validity of the registration certificate are allowed for sale until the expiration date.
The following documentation is required for renewal of registration:
- Module 1;
- Module 2;
- Normative document on quality;
- A copy of the valid Registration certificate.
The period of specialized expert evaluation of the renewal procedure is 50 business days, not including the time for responses to observations (deficiencies).
Positive decision on the renewal grants Registration certificate without expiry.
Cratia provides professional services of state registration (renewals, variations) of medicinal products in Kyrgyzstan. We have an excellent knowledge of national legislation, necessary experience and resources.