With the delay of Brexit, the EMA has issued an update and clarification on its Brexit information page (Link). Meanwhile, there have also been updates from the national regulators in Belgium (AFMPS), Ireland (HPRA) and the UK (VMD).
Application of EU legislation on drug precursors (i.e. substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances) will be impacted and pharmaceutical companies using such substances in the manufacture of VMPs will need to take action (Link – French only).
The HPRA Brexit Guidance (update 26 April 2019) provides a comprehensive explanation of the impact of Brexit to the pharmaceutical industry (Link). The April 2019 version takes into consideration the latest Q & A from the European Commission, relating to batch testing rules, and also addresses queries raised by stakeholders at the recent Brexit information event held at HPRA.
On the VMD website, there is new information on VMPs availability in case of a no-deal Brexit (Link).
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with:
- Dossier preparation, submission & regulatory procedures
- Regulatory intelligence and strategic planning
- Life cycle management
- Key person cover
- Pharmacovigilance
- Brexit support services