The pharmacovigilance system in Moldova is organized taking into account the norms used in the international practice, namely, the Guidelines of the International Conference on Harmonization (ICH) and Directive of the Council of the European Economic Community on Pharmacovigilance No. 75/319.

The Agency for medicinal products and medical devices is the competent authority of Moldova, overseeing adverse events, registration, systematization and analysis of data on adverse reactions. 

Information on adverse reactions/effects of medicinal products is submitted to the Department of registration of medicinal products, clinical evaluation and pharmacovigilance by:

• doctors and pharmacists of all medical institutions of the Republic of Moldova, regardless of the form of ownership;
• manufacturers/owners of the Registration Certificate or their authorized representatives;
• authorized international organizations (WHO: World Health Organization, EC: European Community, etc.);
• medical information sources and scientific publications;
• public organizations that represent the interests of consumers of medicinal products, as well as citizens;
• Ethics Committees (during clinical trials of medicinal products);
• investigators of clinical sites involved in conducting clinical trials of medicinal products.

Marketing Authorization Holder must designate the Local Contact Person (LCP) responsible for pharmacovigilance in Moldova. The Application for registration or renewal is accompanied by the curriculum vitae of such authorized person.

To change such authorized person, it will be required to submit the application for variations type IB. 

Manufacturers and MAHs of the medicinal products authorized for use in Moldova are required to provide the Pharmacovigilance department with information on any adverse event of the medicinal product, during the first 5 years after obtaining the Registration certificate.

The report on an unexpected serious adverse drug reaction registered in the territory of Moldova and other countries is submitted within 15 days from the receipt of the information.

During the validity period of the Registration certificate of the medicinal product, the Holder should provide the Agency for medicinal products and medical devices with the periodic safety update reports (PSURs) for the registered medicinal product.

The Agency for medicinal products and medical devices may require inspection of the pharmacovigilance system of MAH or it’s LCP.

Cratia provides professional services of establishment and maintenance of pharmacovigilance system in Moldova. 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.