Moldovan health ministry simplifies procedure of authorizing medicines

Chisinau, 13 April /MOLDPRES/ - The Health Ministry has simplified the procedure of authorizing the foreign pharmaceutical production on the Moldovan market.   

“The applicant willing to introduce medicines in Moldova, which are registered by the European Medicines Agency (EMA) or at least in a country from the European Economic Area, or Switzerland, the USA, Canada, Japan and Australia, will submit an application on assessing the file in simplified procedure to the Moldovan Medicines and Medical Devices Agency.  Producers from these countries will no longer have to submit substances of reference, impurities and samples of medication, in order to carry out the quality control at the authorization phase,” a press release by the Health Ministry says.     

Also, the economic agent will submit a declaration on his/her own responsibility, saying that the file lodged is identical with the one accepted by EMA or the national competent regulation authorities from these countries. This measure will raise the awareness of the holder of certificate of medicines’ registration, and will help supervise the medicines, which are to be placed on the Moldovan market, the communiqué also says.    

The period for considering the applications will be shortened from 210 days to 60 days.

The order approved by the Health Ministry is part of the government’s Action Plan for 2016. 

(Reporter P. Beregoi, editor L. Alcaza)