Kyrgyzstan

Kyrgyzstan (Kyrgyz Republic) is one of the post-Soviet countries with a population of about 6 million people, and it is a member of the Eurasian Economic Union (EAEU) along with Russia, Belarus, Armenia and Kazakhstan. Membership of Kyrgyzstan in the EAEU significantly influences regulatory policy of the state: for medicinal products, medical devices, special purpose food products and cosmetics there is currently the choice between the “national” and “unified” registration procedure.

Kyrgyzstan is a country with the fast developing pharmaceutical market. Products of foreign manufacture occupy the dominant position in the pharmaceutical market of the country.

Import and sales of medicinal products, medical devices, special purpose food products and cosmetics are only allowed under condition of availability of the certificate on state legalization. At present the Applicant can choose between the national procedure or the “unified” procedure of the EAEU.

The central executive authority implementing the state health care policy is the Ministry of Health of the Kyrgyz Republic (website: http://www.med.kg/).

Registration of finished medicinal products, medical equipment and medical devices, special purpose food products and cosmetics is carried out by the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic (website: http://www.pharm.kg/).

 

Medicinal products

According to the Law of the Kyrgyz Republic “On Medicinal Products”, import and sales of medicinal products in Kyrgyzstan are only allowed after state registration (renewal).

Registration of medicinal products may be performed at the discretion of the Applicant either under the “national” procedure until 31 December 2020, or under the “unified” procedure; and only under the “unified” procedure of the EAEU after 31 December 2020.

The registration expert evaluation of finished medicinal products is performed by the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic (website: http://www.pharm.kg/).

 

National registration procedure:

Validity period of Registration Certificate is 5 years. The Registration Certificate is issued in the name of the Applicant (Holder) of the registration which can be both a resident and a non-resident of the Kyrgyz Republic.

The Registration Certificate package consists of several documents:

• Registration Certificate itself.
• Approved text of instructions for medical use.
• Reconciled artworks of primary and secondary packaging.
• Reconciled normative document on control of the quality and safety of medicinal product.

Kyrgyzstan is a country with high standards of regulation of marketed medicinal products. Inconsistencies between approved mock ups and actual packaging labelling, instructions for use, certificates of analysis may cause rejection of the medicinal product and temporary or permanent prohibition on sales.

Registration dossier is accepted both in national and in CTD format. Regardless of the format of the registration dossier, it is necessary to develop specific national documents, namely:

• Application form for registration of new medicinal product.
• Normative document that includes composition of finished product, specification for release and shelf life, quality control methods, information on storage conditions, information on the manufacturers, etc.
• Instructions for medical use.
• Mock ups of primary and secondary packaging.
•  

Part of the documents should be submitted with translation into Russian. Part of the administrative documentation should be properly legalized .

The dossier is submitted in electronic and paper forms.  

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.

Registration procedure is provided in accordance with the Resolution of the Government of the Kyrgyz Republic on the approval of Technical Regulation “On the Safety of Medicinal Products for Medical Use” No. 137 dated from 6 April 2011. Duration of expert examination for state registration of a medicinal product is 6-9 months. This period does not include time necessary for an Applicant to pay state fees, duration of laboratory analysis and time for replying to queries and deficiencies. In some cases assessment of production and quality assurance system is performed by conducting inspection a manufacturing site.

Stages of the registration procedure in brief are as following:

1. Preparation of registration dossier.
2. Submission of the dossier and registration samples to the state authority.
3. Obtaining of invoice for conducting expert examination and payment providing.
4. Expert examination (primary and secondary) of the materials provided.  
5. Replying to the expert queries, amendments and reconciliation of the text of instruction for medical use, normative document and package labelling.
6. Laboratory analysis of the samples.
7. Obtaining the positive conclusion of examination.
8. Issue of the order on state registration of the medicinal product.
9. Obtaining the Registration Certificate.

The register of medicinal products approved in the Kyrgyz Republic is available in electronic form: http://212.112.103.101/reestr

 

Renewal  under the national procedure

The application form for renewal of medicinal product should be submitted not earlier than 3 months but not later than one calendar day before expiry of the Registration Certificate.

The following changes are also the reasons for applying for renewal:

• Change of the name of medicinal product without changing its composition.
• Change of the pharmaceutical form, strength, composition and combination of excipients of the medicinal product.
• Change of the name of the Applicant.
• Reorganization of the manufacturing section or manufacturing site of the medicinal product.

The renewal procedure is similar to the registration procedure in Kyrgyzstan. Duration of expert examination is 6-7 months. Based on the results of renewal Registration Certificate is issued for a period of five years.

 

Variations to the Registration Certificate

are performed on the basis of Resolution of the Government of the Kyrgyz Republic on the approval of Technical Regulation “On the Safety of Medicinal Products for Medical Use” No. 137 dated 6 April 2011. Depending on the content of the change, the amendment procedure lasts for 3 to 4 months.

Amendments that require new registration of the medicinal product are as follows:

• Change of active substances.
• Change in therapeutic indications.
• Change of dosing of pharmaceutical form and route of administration.

 

Pharmacovigilance

Basic principles of pharmacovigilance system in the Kyrgyz Republic are established by Article 11 of Law of the Kyrgyz Republic No. 91 “On Medicinal Products” dated 30 April 2003.

Marketing Authorization Holders (MAHs) as well as healthcare and pharmaceutical professionals are obliged to submit information on identified adverse reactions in the manner determined by the Ministry of Health of the Kyrgyz Republic.

Marketing Authorization Holders of medicinal products are obliged to implement, ensure and guarantee implementation and functioning of the pharmacovigilance system in accordance with the requirements of Resolution on the approval of Technical Regulation “On the Safety of Medicinal Products for Medical Use” No. 137 dated 6 April 2011.

The competent state authority for pharmacovigilance system in Kyrgyzstan is the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic (website: http://www.pharm.kg/).

To ensure performance of the pharmacovigilance system manufacturer/MAH of medicinal products should appoint an authorized person responsible for pharmacovigilance in Kyrgyzstan. The pharmacovigilance system of the manufacturer/MAH is a subject to control by the competent authority.

MAHs should submit the following information to the competent authority:

• All cases of serious adverse drug reactions which have been recorded during its medical use in the Kyrgyz Republic.
• All cases of lack of efficacy of medicinal product which have been recorded during its medical use in the Kyrgyz Republic, and emerged during treatment.
• All cases of suspected serious unexpected adverse drug reactions that were fatal or life-threatening.
• All cases of adverse reactions that may cause changes in the risk/benefit ratio.

MAHs are required to submit Periodic Safety Update Reports (PSURs) to the competent state body of the Kyrgyz Republic for all medicinal products registered in the Kyrgyz Republic with the following intervals:

• Every 6 months during first 2 years after obtaining the Registration Certificate.
• Once a year during next 3 years.
• Every 5 years in case if medicinal product is marketed in the Kyrgyz Republic.
• Immediately upon request of the competent state body of the Kyrgyz Republic responsible for the health care and medicinal products circulation.

 

Medical devices and equipment

Medical devices and medical equipment of foreign production may be imported and sold in the territory of the Kyrgyz Republic after their state registration. Currently application form for registration may be submitted both according to “national” Kyrgyz and “unified” procedure of the EAEU.

Below is the description of the national procedure. The description of the procedure for registration of medical devices within the framework of the Eurasian Economic Union is described on a separate page of our website.

The national registration procedure is performed on the basis of Resolution of the Government of the Kyrgyz Republic on approval of the Technical Regulations “On the Safety of Medical Devices” No. 74 dated 1 February 2012.

Registration Certificate is issued for a period of 5 years for medical products or for a period of 7 years for medical equipment. The Applicant of registration may be an entity which produces or places an order for production of medical devices and medical equipment.

It is not required to appoint a local authorized representative of the manufacturer.

Registration dossier may be submitted in English with translation into Russian. Languages of labeling and instructions for use (user manual) are Russian and/or Kyrgyz.

The registration procedure is performed by the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic.

The stages of the registration procedure are as follows:

1. Preparation of registration dossier.
2. Submission of application form, registration dossier and samples of the medical device to the competent authority.
3. Obtaining of invoice from the authority for registration procedure and providing payment.
4. Expert examination of the registration dossier for the medical device.
5. Consideration of facts and circumstances that pose a threat to life and health of people when using registered medical devices.
6. Technical testing.
7. Clinical trials (only required for medical devices and equipment of classes IIa, IIb and III).
8. Consideration of the results of the technical and clinical trials, issue of the protocol on recommendation for use of the medical device in medical practice.
9. Issue of the Registration Certificate and adding the medical devices data to the state register/

The register of medical equipment and medical devices of the Kyrgyz Republic is available in electronic format: http://212.112.103.101/reestr

Renewal of medical devices and medical equipment is performed in the event when the validity of the Registration Certificate expires. The renewal procedure is performed in the manner provided for the registration procedure, without conducting clinical trials.

During validity of the Registration Certificate variations to registration materials are provided.

 

Special purpose food products

According to the legislation of the Kyrgyz Republic, import and sales of special purpose food products in Kyrgyzstan are only allowed after state registration (renewal). Registration of special purpose food products may be performed according to the “national” procedure (the Registration Certificate is valid only in the territory of Kyrgyzstan) or under the “unified” procedure (the Registration Certificate is valid in all countries of the EAEU).

The registration expert evaluation of special purpose food products is performed by the Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic (website: http://www.pharm.kg/).

Registration Certificate package consists of several documents as follows:

• Registration Certificate itself.
• Reconciled text of instructions for use (if necessary).
• Reconciled mock ups of primary and secondary packaging.

Validity period of the Registration Certificate is 5 years.

Registration dossier is accepted in national format and includes specific national documents, namely:

• Application form for registration of special purpose food product.
• Instructions for use (if necessary).
• Mock ups of primary and secondary packaging.

Package labeling and instructions for use (if required) should be submitted and approved in Russian and/or Kyrgyz languages.  

The dossier is submitted in electronic and paper forms.

Part of the documents should be submitted with translation into Russian.

Part of the administrative documentation should be properly legalized.

Stages of the registration procedure may be presented as follows:

1. Preparation of dossier.
2. Filing of the dossier and samples to the state authority.
3. Obtaining of invoice for expert examination and payment providing.
4. Expert examination (primary and secondary) of the materials provided.
5. Replies to queries and deficiencies from the experts.
6. Laboratory analysis of the samples.
7. Obtaining the positive conclusion on examination results.
8. Issue of the order on state registration.
9. Obtaining the Registration Certificate.

 

Renewal

Application form for renewal should be submitted not earlier than 3 months, but not later than one calendar day before expiry of the Registration Certificate.

Renewal procedure is similar to registration procedure in Kyrgyzstan. Duration of expert examination activities is 6-7 months. As the results of renewal Registration Certificate is issued for a period of 5 years.

 

Perfume and cosmetic products

According to legislation of the Kyrgyz Republic, import and sales of medical cosmetics in Kyrgyzstan are only allowed after state registration (renewal). Registration of medical cosmetics may be performed according to the “national” procedure (the Registration Certificate is valid only in the territory of Kyrgyzstan) or under the “unified” procedure (the Registration Certificate is valid in all countries of the EAEU).

Registration expert examination of medical cosmetics is performed by Department of Pharmaceutical Supply and Medical Equipment of the Ministry of Health of the Kyrgyz Republic (website: http://www.pharm.kg/).

Registration Certificate package consists of several documents:

• Registration Certificate itself.
• Reconciled text of instructions for medical use.
• Reconciled mock ups of primary and secondary packaging.

Validity period of the Registration Certificate is 5 years.

Registration dossier is accepted in the national format. Regardless of the format of the registration dossier it is necessary to develop specific national documents, namely:

• Application form for registration of medical cosmetic.
• Instructions for use.
• Mock ups of primary and secondary packaging.

Labeling is submitted and approved in Russian and/or Kyrgyz.

The dossier is submitted in electronic and paper forms.

Part of documents should be submitted with translation into Russian.

Part of administrative documentation should be properly legalized.

The stages of the registration procedure may be presented as follows:

1. Preparation of the dossier.
2. Filing of the dossier and samples to the state authority.
3. Obtaining of invoice for expert examination and providing payment.
4. Expert examination (primary and secondary) of the materials provided.
5. Replies to queries and deficiencies from the experts.
6. Laboratory analysis of the samples.
7. Obtaining the positive conclusion on results of examination.
8. Issue of the order on state registration.
9. Obtaining the Registration Certificate.

Application form for renewal should be submitted not earlier than 3 months, but not later than one calendar day before expiry of Registration Certificate. Renewal procedure is similar to registration procedure in Kyrgyzstan.

As the result of renewal Registration Certificate is issued for a period of 5 years.

 

The company Cratia offers the provision of services for state registration of medicinal products, development and maintenance of the pharmacovigilance system, registration (certification) of medical devices, special purpose food products and cosmetics in Kyrgyzstan.