compassionate
Product Authorizations in the EU/EEA
Very frequently do the Pharmacovigilance professionals come across terms such as RMS, MRP/DCP, CAP, CMS, etc., while interacting with the colleagues from the regulatory department. All these concepts are good to know, and are definitely relevant, as Pharmacovigilance requirements may vary across each of these terms. Besides, this is applicable to both human and veterinary […]
Unlicensed Medicines – the Pharmacovigilance Impact!
The COVID-19 situation made it possible for regulatory agencies globally to explore all the four facets of unlicensed medicines, namely: 1. Emergency Use Authorization 2. Compassionate Use 3. Named Patient Basis 4. Expanded Access Program The first and foremost thing to understand is that the medicine in question can fall into any of the following […]