The state registration of medicinal products in the Republic of Tajikistan is carried out by the Ministry of Health and Social Protection of the Population, and the expert evaluation of documentation is conducted by the State Supervision Service for Health Care and Social Protection of the Population of the Republic of Tajikistan.
Registration is performed in the name of the Applicant (Marketing Authorization Holder – MAH). The MAH can be a legal entity, resident or a non-resident of the Republic of Tajikistan. Cratia can represent the interests of the MAH acting as an attorney.
The registration procedure starts with the submission of the Application and the registration dossier to the Supervision Service for Health Care and Social Protection of the Population of the Republic of Tajikistan. Payment of the state fee is carried out after the completion of the expert evaluation of registration documents. Reduced tariffs are provided for manufacturers from the CIS countries.
Registration dossier
The registration dossier is submitted in the national format, the CTD format is accepted by prior approval of the competent authority.
The national structure of the registration dossier includes 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), non-clinical and clinical data.
Instruction for use (package insert) and package labeling are submitted in Tajik or/and Russian language, as a part of the registration dossier. The package can include other languages.
The materials of the registration dossier must be submitted with translation into Russian or Tajik. Administrative documentation must be properly legalized. Samples of the medicinal product and reference standards are also submitted along with the registration dossier.
The inspection of the manufacturing site during the registration process can be required, by the decision of state expert.
The competent authority can inquire additional documents or information during the expert evaluation process. There are no limits for the clock stops, however, the registration process is suspended for the time required for the MAH to provide the answers.
Depending on the type of the medicinal product, the registration period may take from 3 to 6 months.
The Marketing Authorization (registration certificate) is valid for 5 years.
Changes / variations
During the validity of the Marketing Authorization, the Applicant (MAH) must inform the competent authority of any changes. The types of changes are not described in the legislation, the requirements for the content of the documentation should be discussed with the competent authority.
Renewal procedure
At least 3 months before the expiry of the Marketing Authorization, it is possible to submit an Application for the renewal. The renewal procedure and its duration are almost identical to the initial registration, as well as the content of the registration dossier.
For the renewal procedure, it is necessary to update the data on the quality of the registered product (Module 3), provide the PSUR covering the validity period of the Marketing Authorization, as well as information regarding complaints and product withdrawals over the past 5 years in Tajikistan.
As a result of the renewal procedure, a Marketing Authorization (registration certificate) is issued for the next 5 years.
Cratia provides professional services of state registration of medicines in Tajikistan. We have an excellent knowledge of national legislation, necessary experience and resources.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.