The AEMPS provides new information on the adaptation of veterinary medicinal products to QRD v9.0
Regulation (EU) 2019/6 sets January 29 2027 as the deadline for veterinary medicinal products (VMPs) authorized in accordance with the former legislation to be in compliance with the aforementioned regulation For this reason, it is necessary to adapt the summary of product characteristics (SPC), package leaflet (PL) and labelling of these VMPs to version 9.0 of the QRD The AEMPS…
The AEMPS enables a tool to request the inclusion of additional information on the packaging of veterinary medicinal products based on article 13 of Regulation (EU) 2019/6
The AEMPS enables RAEVET for the submission of this information. This system makes access to this service easier for applicants and speeds up the process The AEMPS will allow such inclusion only if it is considered useful information, if it is compatible with the summary of the product characteristics and if it is not considered an advertisement of a veterinary…
