Mission on supervision of Medical Devices market as well as the Trainning on the Risk Assesment System of medicines quality have been organized

Mission on supervision of Medical Devices market as well as the Trainning on the Risk Assesment System of medicines quality have been organized

During 11-15 December 2017, a training on the risk-based enforcement system of medicines quality rules as well as other GMP, GDP and GVP, and another the activities in respect of the supervision of the medical devices market, were organized at the Medicines and Medical Devices Agency in respect of the Activity 2.3 “Development of a risk-based enforcement system of medicines quality rules as well as other GMP, GDP and GVP” and of the Activity 3.1 “Development of a SOP for the supervision of the medical devices market”.

The astivities were implemented by Short Term Experts from the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania and from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland. Lithuanian and Polish experts shared their experience and provided answers to the questions raised by the participants. 

Within the Activity 2.3 “Development of a risk-based enforcement system of medicines quality rules as well as other GMP, GDP and GVP” the Lithuanian and Polish experts shared their practical knowledge and recommendations how to prepare to foresee inspection, how to report observed deficiencies and how the principle of classification of deficiencies is compiled, what actions should be taken in the cases of critical deficiencies, as well as presented the EU harmonized inspection procedures, formats of Inspection report and how to create PhV inspection report. At the end of the training a GVP inspection simulation with the MMDA experts was organized.

Within the Activity 3.1 “Development of a SOP for the supervision of the medical devices market” the Polish experts presented the processes of medical device notifications, issuing of authorisation to conduct a clinical trials, supervision of notified bodies, supervision over manufacturer proceedings concerning incident, supervision over the FSCA conducting, cooperation with customs offices, issuing administrative decision, inspections of manufacturers, authorized representatives, importers and distributors and market control. The Polish experts also helped the MMDA to prepare their own procedures.

As the result of these Activities, a Risk-based enforcement system of medicines quality rules will be developed, MMDA staff trained as well the relevant SOP will be prepared. 

 

 

 

 

 

 

 

 

 

 

 

 

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