How to use the defective product report to notify a quality defect to the Romanian Drug Agency

How to use the defective product report to notify a quality defect to the Romanian Drug Agency

The Romanian Drug Agency (ANMDM) published on their website scientific decision No 4/24.10.2018 implementing the document of European Medicines Agency (EMA) on the defective product report (EMA/INS/GMP/35037/2017). Marketing authorisation holders (MAHs) have to report to ANMDM all the non-conformities related to the quality of medicinal products authorised in Romania under MRP/DCP or purely national procedure. The adopted national reporting form is similar to the one proposed by EMA and has to be sent to ANMDM by e-mail. ANMDM’s recommendation is to have the details of a contact person for Romania included in the reporting e-mail in case additional information is required.

Our experts are able to assist MAHs in reporting quality defects to ANMDM.