Experts of the Medicines and Medical Devices Agency of the Republic of Moldova were trained in the EU marketing authorisation requirements for conducting various marketing authorisation procedures

Experts of the Medicines and Medical Devices Agency of the Republic of Moldova were trained in the EU marketing authorisation requirements for conducting various marketing authorisation procedures

During 17-23 September 2017, the first mission of the Study visit in respect of the Component 2 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. 

Three MMDA experts involved in the marketing authorisation procedures were familiarized with the main medicines marketing authorisation procedures applied in the European Union. The study visit was organized by the staff of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (SMCA) and took place at the premises of the SCMA in Vilnius and Kaunas (the Republic of Lithuania).

During one week, the Moldavian experts were familiarised with the marketing authorization processes introduced in the SMCA, the databases used in the SMCA as well as trained on the various activities related to the authorisation of the medicinal products (primary evaluation and validation of the dossiers, assessment of the quality, safety and efficacy of medicinal products, management and approval of variation procedures). As well, Lithuanian experts shared their practical knowledge and experience on the authorisation of medicinal products in Lithuania. 

Additionally, the MMDA experts made visits to the Museum of the History of Lithuanian Medicine and Pharmacy as well as to the Faculty of Pharmacy of the Lithuanian University of the Health Sciences where MMDA delegates visited research laboratories and were introduced to on-going research projects.

The goal of this study visit is to share the best EU practice in the authorisation of medicinal products procedures, to increase the administrative capacities of the MMDA staff as well as to improve professional qualification. It is expected that the experience gained during the exchange visit will allow guests from the Republic of Moldova to perform functions more efficiently.

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.

The EU-funded Project will be implemented over a 24 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 medicinal products manufacturing, marketing, pharmacovigilance, distribution and pricing and medical devices in scope of market supervision, vigilance and registration as well as to clinical trials and pharmaceutical activity.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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