Serialisation: New Guidance for EU Inspectors

Serialisation: New Guidance for EU Inspectors

Europe The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the FMD regulation. Questions listed in the document focus for example on: Connection with hub and On-Boarding Partner (OBP) Data Flow...
Medicine shortages: improved reporting and communication?

Medicine shortages: improved reporting and communication?

Europe The European Union taskforce  has published two documents: 1) guidance for marketing authorisation holders on reporting of shortages in the EU. The document provides guidance to the pharmaceutical industry to facilitate the detection and early notification to...

What to do: Post-Brexit

EU To prepare the UK’s withdrawal from the EU, EMA and the European Commission published the first in a series of Q&As for pharmaceutical companies on May 31st 2017. This guidance applies to pharmaceutical companies of both human and veterinary medicines and...