During 05-09 November 2018, the second 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.
Four MMDA experts involved in the GDP and GMP inspections were familiarized with the GDP and GMP inspection process following the EU requirements for conducting and reporting of GDP 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 in Vilnius (the Republic of Lithuania).
The main purpose of the study visit (GMP and GDP part) within the Activity 4.6 was familiarization with the main procedures of GMP and GDP 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 EU requirements to be applied, as well as acquisition of practical knowledge in the area of GMP and GDP.
During one week, the Moldavian experts were familiarised with the EU harmonized inspection procedures, formats of Inspection report, certificates, GMP and GDP non-compliance, as well as national formats and procedures used in the activity of the SMCA.
Additionally, the SMCA experts organized two planned GMP and GDP inspections performed in conjunction with enforcement procedures in Lithuania, where qualified GMP and GDP 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 specialists of the MMDA 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.