Tajikistan

The population of Tajikistan is 8.8 million people. Import plays an important role, and in 2013 it accounted for 97% of the total pharmaceutical market.

It is permitted to import and sale medicines only after state registration. It is also necessary to obtain a registration certificate to import medicinal products and medical devices. Biologically active additives and medicated agents, baby food, sanitary and hygiene supplies and cosmetic products endowed with therapeutic and prophylactic properties in accordance with the legislation, are included in the list of products under mandatory certification, also go through state registration.

The main legislative acts regulating the admission and sales of medical products are the Law of the Republic of Tajikistan “On Medicines and Pharmaceutical Activities”, Decree of the Government of the Republic of Tajikistan No. 210 dated 03.05.2010 “On Approval of the Certification Procedure of Medicines and Medical Goods”, and Order of the Ministry of Health and Social Protection of the Republic of Tajikistan No. 736  dated 21.08.2015 “On Approval of “Procedure for State Registration of Medicines and Medical Goods in the Republic of Tajikistan”.

Medicinal products

The state registration of medicines in the Republic of Tajikistan is carried out by the Ministry of Health and Social Protection, and the documentation examination is performed by the State Service for Control of Healthcare and Social Protection of the Republic of Tajikistan.

Registration is carried out in the name of the Applicant company (registrant). The Applicant can be a resident or non-resident legal entity of the Republic of Tajikistan. The company “Cratia” may represent the interests of the Applicant by proxy.

The registration procedure begins with the submission of the Application and the registration dossier to the State Service for Control of Healthcare and Social Protection of the Republic of Tajikistan. Payment of the state fee is carried out after the completion of the examination of registration documents.  Tariff reductions are provided for manufacturers from the CIS countries.

The registration dossier should be submitted in the national format, the CTD format is not accepted. The registration dossier should be submitted in Russian or Tajik. Administrative documentation must be properly legalised. Samples of the medicinal product and reference standards are also submitted along with the registration dossier.

The inspection of production during the registration process is not required, although in rare cases can be appointed.

In the process of examination, the Service has the right to request additional documents or information. The time limit is not established, for the mean time the registration process is suspended.

The registration period may range from 3 to 6 months, depending on the type of medicinal product.

The registration certificate is valid for 5 years. The instruction and marking in Russian are approved during the registration.

Introduction of changes and re-registration

The Applicant must inform the competent authority of any changes during the validity of the registration certificate. The types of changes are not listed in the legislation, the requirements for the package of documentation are discussed with the competent authority.

It is possible to submit an Application for the re-registration at least 3 months before the registration certificate expiration. The procedure of re-registration and its duration are almost identical to the new registration, the list of the required documents is also similar.

Pharmacovigilance

The institutions authorized by the Ministry of Health of the Republic of Tajikistan organize the collection, systematization and analysis of data collected for adverse events of medicinal products and specifics of interaction. This information is periodically submitted to the Ministry of Health of the Republic of Tajikistan.

To date, the Applicant has no obligation to establish and maintain a pharmacovigilance system in the Republic of Tajikistan, as well as no obligation to provide information on undesirable events (adverse reactions) of medicinal products.

Despite the absence of a mandatory requirement to establish and maintain a pharmacovigilance system, “Cratia” offers a range of activities to manage the safety of the medicinal product in the Republic of Tajikistan. We are ready to offer outsourcing of a local contact person, collection of data on undesirable events, monitoring of literary sources and websites, periodic review and update of instructions for use.

Healthcare products and medical devices

Medical products, which include healthcare products, medical devices and patient care products are subject to mandatory state certification.

Registration is carried out in the name of the Applicant company (registrant). The Applicant can be a resident or non-resident legal entity of the Republic of Tajikistan. The company “Cratia” may represent the interests of the Applicant by proxy.

Registration is carried out based on the submitted Application and the package of documents, samples may also be required. The registration dossier is submitted in Russian.

The registration certificate of medical products is valid for 5 years.

Foods for particular nutritional uses

It is necessary to pass mandatory certification in the competent authority for importation and sales of foods for particular nutritional uses endowed with therapeutic and prophylactic properties.

An Application, a package of documents and samples of the finished product are submitted for the registration (certification). The documentation and toxicological studies of the samples are examined in the course of the examination.

Registration of foods for particular nutritional uses is valid for 5 years.

Cosmetic products

According to Appendix No. 1 to the “Certification Procedure of Medicines and Medical goods” cosmetic products endowed with therapeutic and prophylactic properties are included in the list of products under mandatory certification.  State Service for Control of Healthcare and Social Protection of the Republic of Tajikistan is the competent authority that performs registration of such products. The registration certificate is issued for a period of 5 years.

Other cosmetic products (without therapeutic and prophylactic properties) are certified by the Agency of Standardization, Metrology, Certification and Trade Inspection under the Government of the Republic of Tajikistan (Tajikstandard).

“Cratia” can perform services on state registration of medicinal products, establishment and maintenance of a pharmacovigilance system, registration of foods for particular nutritional uses and cosmetic products in Tajikistan.