How will Medical Devices be regulated following the end of the Brexit Transition Period
This whitepaper summarises the key elements of MHRA’s guidance document on medical devices, regarding registration, assessment procedures, labeling, post-market surveillance, and vigilance that will apply for devices placed on the market in Great Britain (England, Wales, and Scotland) and Northern Ireland. This document provides a list of actions that manufacturers of medical devices should take in order to continue the placement of their products on the EU and UK markets.
Posted:
DownloadBrexit Considerations for Industry: The current Position
The UK formally left the EU on 31st January 2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31st December 2020. During this transition period the UK has continued to remain under EU pharmaceutical law. Our PharmaLex.perts have created an interesting Whitepaper, which introduces you to important current considerations about Brexit for the industry.
Posted:
DownloadNitrosamines - information for MAHs
This paper gives details on the background and recommended steps required to ensure your medicinal products comply with the latest guidance for nitrosamines.
Posted:
DownloadManage effectively your Merger and Acquisition activities
Companies engaging in Merger and Acquisition (M&A) activities aim to gain momentum by undertaking one or a combination of the following to: Level of Regulatory Affairs Involvement with M&A Programs, Increase market share by consolidating their product portfolio into specific therapeutic areas, Replenish their previously dwindling product pipeline, Enter into emerging markets with existing and new products, Reduce costs through the consolidation of manufacturing sites.
Posted:
Download