During 17-21 December 2018, the third mission of the Study visit in respect of the Component 4 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.
Two experts from the MMDA and the National Agency on Public Healthcare under the Ministry of Health, Labour and Social Protection of the Republic of Moldova were familiarized with the good pharmacy practice (GPP) inspection process following the requirements for conducting and reporting of GPP inspections, applying of necessary and appropriate administration measures. The study visit was organized by the staff of the Ministry of Health of the Republic of Lithuania and the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (SMCA) and took place in Vilnius (the Republic of Lithuania).
The main purpose of the study visit (GPP part) within the Activity 4.6 was familiarization with the main procedures of GPP inspection applied in the SMCA, familiarization with all the steps, requirements for competence of experts, traceability, documents and data management, decision making criteria and other requirements to be applied, as well as acquisition of practical knowledge in the area of GPP.
For one week, the Moldavian experts were familiarised with the inspection procedures, formats of Inspection report, certificates, GPP non-compliance, as well as national formats and procedures used in the activity of the SMCA. Also, discussions on legal framework on supervision of pharmacies, licencing of pharmacy activity, licencing of activity with narcotic and psychotropic activity were organized.
Additionally, the SMCA experts organized one planned GPP inspection performed in conjunction with enforcement procedures in Lithuania, where qualified GPP inspectors shared their practical knowledge and recommendations how to prepare to foresee inspection, in what ways to conduct inspection, how to report observed deficiencies, how the principle of classification of deficiencies is compiled, etc.
Also, the SMCA introduced the Moldavian specialists with actions following inspection, such as suspension of the licence, sanctions for pharmacist, as well as further investigation if necessar, such as suspected quality defect of medicinal product.
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.