To the attention of Marketing Authorisation Holders
On the NAMMD website, under the heading “Medicinal products for human use/Pharmacovigilance/Special warnings”, interested pharmaceutical companies will find the Romanian version of agreed text of the Recommendations of the Pharmacovigilance Working Party (PhVWP) of the European Medicines Agency (EMA). These recommendations are implemented through variation.
The deadlines for variation submission will be specified by the National Procedure Department in the request for submission of the application for variation.”