During 23-27April 2018, the third 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 GVP and GMP inspectionswere familiarized with the GVP and GMP inspection process following the EU requirements for conducting and reporting of GVP and GMP inspections, applying of necessary and appropriate administration measures. 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 premise of the SCMA in Vilnius (the Republic of Lithuania).
During one week, the Moldavian experts were familiarised with the EU harmonized inspection procedures, formats of Inspection report, certificates, GMP and GVP non-compliance, as well as national formats and procedures used in the activity of the SMCA.The guests also participated in the pharmacovigilance audit. In addition they were introduced to routine pharmacovigilance activities such as adverse drug reaction, signal management and the risk minimisation measures assessment processes.
Additionally, the SMCA experts organized two observed GVP and GMP inspections performed in conjunction with enforcement procedures in Lithuania where qualified Lithuanian GVP and GMP inspectors shared their practical knowledge and recommendations onhow to prepare a foreseen inspection, in what ways inspection can be conducted including plant tour, how to report observed deficiencies and how the principle of classification of deficiencies is compiled, what actions should be perform in cases of critical deficiencies and GVP/GMP non-compliances.
The goal of this study visit is to share the best EU practice in the GVP and GMP inspection process following the EU requirements for conducting and reporting of GMP and GVP inspections, 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.