Tajikistan: Safeguarding Public Health Through Comprehensive Regulation

Registration of Medicines

• The State Supervision Service for Health Care and Social Protection of the Population of the Republic of Tajikistan conducts expert evaluation of documentation.
• The Ministry of Health and Social Protection of the Population handles the state registration of medicinal products in the country.
• The applicant (Marketing Authorization Holder, or MAH) is the name under which registration is carried out. The MAH may be a resident or non-resident of the Republic of Tajikistan, as well as a legal organization.
• The application and registration dossier must be submitted to the Republic of Tajikistan’s Supervision Service for Health Care and Social Protection of the Population to begin the registration process.
• Once an expert review of the registration documents is finished, the state fee is paid.
• Manufacturers from the CIS nations are eligible for lower tariffs.

Understanding the requirements for pharmaceutical registration in Tajikistan can help applicants prepare the necessary documents and navigate the registration process more efficiently.

Registration Dossier

• The registration dossier is submitted in the national format, with the CTD format being accepted upon prior approval from the competent authority.
• administrative documentation (registration in the country of manufacture and other countries, GMP certificate, manufacturing license), quality data (composition, specification, methods of control of the finished product, certificates of analysis, summary of the manufacturing process, stability data), and non-clinical and clinical data are all included in the national structure of the registration dossier.
• The registration dossier includes instructions for use (package insert) and package labeling supplied in Tajik and/or Russian. Other languages may be included in the bundle.
• The registration dossier documents need to be translated into Tajik or Russian before being submitted. Legalization of administrative paperwork is necessary. Along with the registration dossier, samples of the medication and reference standards are also supplied.
• A state expert may decide to require the production facility to be inspected as part of the registration procedure.
• Throughout the expert evaluation process, the responsible authority may request further records or data. The registration process is halted while the MAH gathers the necessary information, but there are no time restrictions on the clock pauses.

Changes / variations

• The Applicant (MAH) is required to notify the relevant authorities of any changes that occur while the Marketing Authorization is in effect.
• The sorts of revisions are not specified in the law; instead, the relevant authorities should be consulted regarding the requirements for the documentation’s content.

Companies planning pharmaceutical registration in Tajikistan should verify the latest requirements with the competent authority and ensure that their registration dossiers are complete before submission.