by In2Pharma | Nov 4, 2019 | News
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...
by In2Pharma | Sep 25, 2019 | News
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...
by In2Pharma | Jun 22, 2017 | News
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...