The pharmacovigilance system in Mongolia is established by the Order of the Minister of Health No. 415 dated November 7, 2013 “On approval of registration of data on the side effects of medicinal products and safety information and rules”.
The competent authority of the pharmacovigilance system in Mongolia is the Department (division) on medicinal products and medical devices of the Ministry of Health.
Applicants (manufacturers) are not required to appoint an authorized person responsible for pharmacovigilance in the territory of Mongolia. However, distributors and manufacturers are required to submit a summary drug safety report (PSUR) to the Department on medicinal products and medical devices of the Ministry of Health within the following timelines:
- every six months during the first 3 years after registration,
- every year for the next 2 years,
- upon each renewal thereafter.
Cratia provides professional services of establishment and maintenance of pharmacovigilance system in Mongolia. 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.