Changing Regulatory Information Gets Easier For Pharma As Of February
This article was originally published in SRA
As of Feb. 1, marketing authorization holders operating in the EU will no longer have to submit type IA variations to notify the competent authorities of any changes they make relating to their qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMFs)1.
You may also be interested in...
The latest list of marketing authorization applications under review by the European Medicines Agency includes filings for eight new products.
Viela and Roche both now have marketing applications that are being reviewed by the European Medicines Agency. If approved in the EU, their products will compete with Alexion’s blockbuster Soliris.
Most of the products currently supplied under Australia’s custom-made medical device exemption will no longer be eligible for supply in this way.