Brexit – extension, extension, extension

Brexit extension date is now 31 October 2019, but there’s not time to be complacent. Are you planning to submit a Marketing Authorisation Application (MAA) for a Non-Prescription Medicine? If you are preparing an MAA for a Non-Prescription Medicine for a Decentralised (DCP) or Mutual Recognition Procedure (MRP) you will need to prepare a ‘Justification […]

Environmental Risk Assessment (ERA) – revised guideline to assess risk of human medicines for the environment…….

An Environmental risk assessment (ERA) of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified. The EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders […]

Brexit – because it affects you too…

The European Union is arguably the world’s most powerful bloc and very soon it’s about to lose the United Kingdom, one of its biggest members. How and when the UK leaves the EU will have further implications that ripple around the globe. So if you’ve heard about Brexit but haven’t been keeping up with every […]