The closing ceremony organised on 5 March 2019 by the Delegation of the European Union to the Republic of Moldova, the Medicines and Medical Devices Agency of the Republic of Moldova, the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland marked the end of implementation of the EU-funded Twinning project “Strengthening of the Medicines and Medical Devices Agency of the Republic of Moldova as regulatory agency in the field of medicines, medical devices and pharmaceutical activity”.
The EU-funded Project was implemented over a 26 months period. The main purpose this EU-funded project worth 1 100 000 EUR is to strengthen the functioning of the MMDA with regards to clinical trials, marketing authorisation, manufacturing and distribution authorisation, vigilance, pricing and distribution of medicinal products and medical devices, authorisation of pharmaceutical activity as well as supervision and reinforcement. The completion of this project delivered the MMDA with capacities at the same level as peer institutions in the EU Member States.
The Ambassador of the Republic Poland to the Republic of Moldova H.E. Mr. Bartłomiej Zdaniuk congratulated the Twinning Teams and noted „We are ready to cooperate with the Republic of Moldova. You have made a huge step forward to join us and we welcome this and we need to go together: the European Union, the EU member states and the Republic of Moldova, this beautiful and friendly country.“
The General State Secretary of the Ministry of Health, Labour and Social Protection, Mr, Boris Gilca, said that the Twinning project “is the most valuable project within the health system that will allow the approximation to the legal framework and the standards of the European Union regarding the functionality of a state institution”.
The Head of Operations Section of the EU Delegation to the Republic of Moldova, Mr. Marco Gemmer: “The European Union supports the right of the citizens of the Republic of Moldova to benefit from safe, effective and affordable medicines. The Agency for Medicines and Medical Devices must be strong and efficient, equal to the EU peer organisations, to deliver this right”.
As a Member State Project Leader Mr. Gintautas Barcys claimed that the project has managed to open up spaces for fruitful and productive collaboration among Lithuanian, Polish and Moldavian partners and health agencies will strive for the future collaboration in the areas of medicinal products, medical devices and pharmaceutical activity.
The Junior Member State Project Leader Dr. Grzegorz Cessak added that “the final rate of success of the Twinning Project is measured with mandatory results achieved, goals accomplished. In this technical terms we have solid reasons to be satisfied. The Polish partner was engaged in broad scope activities and now we are concluding this Twinning with an impression of the hard work done by all participants and achieved amazing outcomes”.
The most important activities and achievements have been presented Ms. Anželika Oraitė, the Resident Twinning Adviser to the Republic of Moldova, namely: well-trained beneficiary country staff, approximation of the legal framework to EU acquis, strengthened institutional and organizational capacities of the beneficiary country as well, good collaboration among Lithuanian, Polish and Moldavian Agencies in the area of medicinal products, medical devices and pharmaceutical activity.
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 (“MMDA“) for joining the EU regulatory agencies network as an equal partner.
The EU-funded Twinning project was implemented by the EU MS partners – Ministry of Health (Republic of Lithuania), State Medicines Control Agency under the Ministry of Health (Republic of Lithuania), Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Republic of Poland) and Central Project Management Agency (Republic of Lithuania) in cooperation with the partner institution in the Beneficiary Country – Medicines and Medical Devices Agency of the Republic of Moldova, Ministry of Health, Labour and Social Protection of the Republic of Moldova, National Agency on Medical Insurance, Centralized Procurement Centre for Health, and National Agency for Public Healthcare.
EU Twinning is an instrument launched by the European Commission with a view to assist EU Candidate countries and newly accepted EU MS to harmonise national legislation with the acquis of the European Union. Representatives from the public administrations of the EU MS and of beneficiary country work together in order to transfer the know-how and good practices developed within the EU to beneficiary public administrations during implementation of the Twinning Project.