Medicinal products - legal regulation
Laws and regulations
Current laws and regulations in force, as available in German from the Austrian Legal Information System (RIS)
Labelling, Package Leaflet and Summary of Product Characteristics (QRD-Templates)
According to the above mentioned regulations on labelling, PL and SmPC of medicinal products, the QRD templates have to be used for creating the respective texts.
Please note that also for purely national procedures the corresponding QRD Template for product information has to be used:
- for human medicinal products the MRP, DCP product-information template,
- for veterinary medicinal products the veterinary CP product-information template.
Please note that the QRD-Template is one single document for Summary of Product Characteristics, Labelling and Package Leaflet. These documents have to be submitted separately to the BASG.
The QRD-Templates provide space for specific national requirements, the so-called “bluebox information”. This information is published on the Heads of Medicines Agencies (HMA) website in the form of stand-alone documents:
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union" - Eudralex
New legislation on falsified medicines 2011/62/EU
Created: 24.03.2009 | Page last modified: 14.09.2015