EXPERTS OF THE MEDICINES AND MEDICAL DEVICES AGENCY OF THE REPUBLIC OF MOLDOVA ACQUAINTED EXPERIENCE OF LITHUANIAN DELEGATES CONTRIBUTING TO THE RELEVANT EUROPEAN MEDICINES AGENCY WORKING GROUPS

During 17-21 December 2018, the second mission of the Study visit in respect of the Component 5 of the EU-funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova (MMDA) as regulatory agency in the field of medicines, medical devices and pharmaceutical activity” was organized.

During one week, two MMDA assessors were familiarized with the principles of work of the European Medicines Agency (EMA) and the structure and scope of the main EMA committees and working parties. 

The main attention was focused on the introduction to the pharmacovigilance and the main issues related to it, such as collecting and managing data on the safety of medicinal products, evaluating the data and making decisions with regard to safety issues, pro-active risk management to minimise any potential risk associated with the use of the medicinal products, acting to protect public health (including regulatory action), communicating with and informing stakeholders and the public. 

Additionally, Lithuanian experience gained in the EU committees and working/expert groups on representing Lithuanian interests, the Lithuanian Presidency of the Council of the EU in 2013, as well as Lithuanian experience on harmonization of national legislation with EU requirements was presented to the Moldavian experts.

Also, information on different procedures and practices of the EMA and its committees in safeguarding patient health in Europe were presented and discussed. 

The study visit was organized by the staff of the Ministry of Health of the Republic of Lithuania, the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania and the Medicines Control Laboratory and took place in Vilnius (the Republic of Lithuania).

The visit to the Republic of Lithuania rendered the knowledge to the MMDA assessors about the experience of the Lithuanian experts in their work in EMA, work particularities, expertise knowledge and other relevant experiences. 

The overall objective of this EU-funded Twinning project is full and correct implementation of the EU acquis in the area of medicinal products and medical devices and preparation of the Medicines and Medical Devices Agency of the Republic of Moldova for joining the EU regulatory agencies network as an equal partner.

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(c) 2015. Agenţia Medicamentului şi Dispozitivelor Medicale