Republic of Moldova

Regulatory

The main regulation of the Pharmaceutical market in the Republic of Moldova is subject especially to the Law “On pharmaceutical use” No. 1456 from 1993, and Law “On Drugs” No. 1409 from 1997 and Law ” regarding the circulation of narcotic substances, psychotropics and precursors” No. 382 from 1999, as well as other relevant government decisions.

Authority

The competent authority in the field of medicines, medical devices and pharmaceutical activity is the Agency of  Medicine and Medical Devices, which exercises state control and supervision of the pharmaceutical activity of natural and legal persons, regardless of the type of property and exercises the following functions:

• Authorization (expertise, approval and registration) of medicines;
• Monitoring the quality of medicines;
• Supervision and control over pharmaceutical activity;
• Monitoring and coordinating the supply process with medicines and pharmaceutical-national assistance;
• Regulation in the field of medicine and pharmaceutical activity;
• Carrying out the informational activity in the field of medicine;
• Carrying out the methodological-organizational and consulting activity within the pharmaceutical companies and the medical service providers;
• Licensing of the pharmaceutical activity.

The authorization of medicines is established by the Ministry of Health, Labor and Social Protection of the Republic of Moldova. The law establishes a period of authorization of medicines up to 20 days from the date of submission of the authorization application.

The basis for the pharmaceutical activity is the license and the accreditation certificate. License is issued for pharmaceutical activity, including the use of narcotic and (or) psychotropic preparations, carried out by private pharmaceutical companies and (or) institutions, import and (or) production of perfume and cosmetic articles.

The import of unregistered medicines, other pharmaceutical and parapharmaceutical products and unregistered medicinal raw materials, carried out for registration, is carried out based on the authorization issued by the Agency of Medicines and Medical Devices. The import authorizations are issued to the economic agents registered on the territory of the Republic of Moldova in an established manner and are not transferable.

Pharmaceutical Market of the Republic of Moldova

Among domestic manufacturers of medicines is Balkan Pharmaceuticals, Farmaco, and Farmaprim.

The specific steps to be taken by pharmaceutical companies to operate, including:

• Evaluation, accreditation and licensing of the institution;
• Authorization and introduction into the State Nomenclature of medicines;
• Registration of medicines in the National Register of producer prices for medicines;
• Authorization of import of medicines.

Additionally, the activity of pharmacies is restricted by the need to comply with conditions regarding location and marketing prices.

 

Author: 

Ilona Nicula
Managing Partner
Popa & Associates
office@popa.md