May 2019 update - Brexit delay and updated guidance on controlled drugs, batch testing rules and VMPs supply in the UK

Brexit news updates from EMA, AFMPS, HPRA and VMD
14 May, 2019

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).

AFMPS provides advice to manufacturers using controlled drug precursors

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).

HPRA clarifies guidance on batch testing rules in updated PDF 

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.

VMD addresses concerns about VMPs supply in a no-deal Brexit

On the VMD website, there is new information on VMPs availability in case of a no-deal Brexit (Link).


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