The legislation of Turkmenistan on pharmacovigilance is being established. The draft Order for Monitoring the Safety of Medicinal Products has been developed, but not officially approved.
The competent authority of the pharmacovigilance system is the Ministry of Health and Medical Industry of Turkmenistan.
At the legislative level, the Applicant (Marketing Authorization Holder) is not required to establish and maintain a pharmacovigilance system, to appoint an authorized person responsible for pharmacovigilance.
Requirements for the submission of the periodic safety update report (summarized data on the adverse effects of the medicinal product – PSUR):
- Once every 6 months – within 2 years after receiving a Marketing Authorization;
- Annually over the next 3 years;
- Subsequently – once every 5 years (in case of re-registration of the product).
Cratia provides professional services on the establishment and maintenance of pharmacovigilance in Turkmenistan. We have an excellent knowledge of national legislation, necessary experience and resources.