The population of Moldova is approximately 3.5 million people. More than 80% of the market for medical and pharmaceutical products is covered by import. The market volume of medicinal products and medical devices is growing annually. The Government of Moldova has taken a number of actions aimed at increasing the number of reimbursed medicinal products, attracting international manufacturers and improving competition in the pharmaceutical market, as well as expanding the network of pharmacies in rural areas in 2016-2017.
The regulatory system of the Republic of Moldova is independent, but the legislation regarding medical products is in active harmonization with the legislation of the European Union. Simplified registration procedures are provided for medical products authorized in the market of the EU and other countries with high regulatory requirements.
Medicines must undergo state registration before placing to the Moldavian market. All medical devices are subject to state registration based on conformity assessment procedures prior to entering the Moldavian market. Special food products undergo notification or registration procedures and must comply with the requirements of the Sanitary Regulations on food additives. Imported cosmetic products are certified in the process of customs clearance.
The Ministry of Health, Labour and Social Protection of the Republic of Moldova.
The central executive authority implementing the state health care policy
The Agency for medicinal products and medical devices of the Republic of Moldova
The competent authority, responsible for authorization (expert evaluation, homologation and registration) of medicinal products, quality control of medicinal products, oversight and control of pharmaceutical activities
Main legislative acts:
- Law of the Republic of Moldova No. 1456-XII “On pharmaceutical activities” dated May 25, 1993;
- Law of the Republic of Moldova No. 1409-XIII “On medicinal products” dated December 17, 1997;
- Order of the Ministry of Health of the Republic of Moldova No. 739 “On authorization of medicinal products for human use and approval of post-marketing changes” dated May 13, 2012;
- Law “On safety of food products” dated April 5, 2017;
- Resolution No. 705 “On approval of the Regulation concerning conditions for the placing on the market of medical devices” dated July 11, 2018;
- Order No. 358 “On approval of the Regulation concerning the conduct of pharmacovigilance activities” dated May 12, 2017;
Cratia provides professional services of state registration of medical (healthcare) products in Moldova. We have an excellent knowledge of national legislation, necessary experience and resources. We offer:
- registration of medicinal products in Moldova;
- establishment and maintenance of the pharmacovigilance system in Moldova;
- certification (conformity assessment / notification) of medical devices in Moldova;
- certification of special food products in Moldova;
- certification of cosmetic products in Moldova.