The basic principles of pharmacovigilance are laid down in the Law of the Republic of Armenia “On Medicines”. The pharmacovigilance system in the territory of Armenia is regulated by Order of the Ministry of Health No. 23-N dated May 17, 2017 “The order of recording and reporting cases of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines; collecting, reporting, monitoring, submitting reports and analyzing data on adverse reactions of medicines, approving the form of the register of adverse reaction and form of reporting of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines”.

The basis of the pharmacovigilance system is the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union, which requires the appointment of a pharmacovigilance contact person at the national level (LCP).

The competent authority responsible for pharmacovigilance is the Scientific Center for Drug and Medical Technology Expertise, which since 1997 has been a member of the WHO International Program for Monitoring Adverse Drug Reactions (Uppsala, Sweden), constantly monitors adverse drug reactions in Armenia.

According to the local legislation of the Republic of Armenia, the MAHs for the registration of medicinal products, medical institutions, pharmacies and institutions and organizations engaged in the consumption and use of medicinal products are obliged to immediately inform the authorized government body about cases of adverse reactions.

The Аpplicant (Мarketing Аuthorization Нolder) is required to appoint a contact person responsible for pharmacovigilance in Armenia. The duties of such a person include as follows:

• submission of information (CV) to the competent authority;
• monitoring, analysis and submission of information about adverse reactions (lack of efficacy and suspected falsification) to the competent authority;
• management of data on adverse reactions, maintaining a local database;
• preparation of a risk management plan (RMP) and management of measures to minimize risks;
• monitoring of literature and other sources regarding medicine safety;
• submission of periodic safety reports;
• providing communications on issues related to the safety of medicinal products received from all participants in the pharmacovigilance system. 

The competent authority has the right to inspect the pharmacovigilance system of the Мarketing Аuthorization Нolder, both locally and globally. The inspection is carried out for compliance with the requirements of good pharmacovigilance practice of the EAEU.

Cratia provides professional services on the establishment and maintenance of pharmacovigilance in Armenia. We have a deep knowledge of the national legislation, significant experience, and necessary 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.