Regulatory Focus™ > News Articles > 2019 > 9 > MHRA Explains Exceptions and Modifications to EU GVP in No-Deal Brexit

MHRA Explains Exceptions and Modifications to EU GVP in No-Deal Brexit

Posted 27 September 2019 | By Michael Mezher 

MHRA Explains Exceptions and Modifications to EU GVP in No-Deal Brexit

With a potential no-deal Brexit looming next month, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday released guidance explaining some provisions of EU good pharmacovigilance practice (GVP) "will no longer apply to the MHRA and UK MAHs [marketing authorization holders] or are to be read subject to modification in a no-deal Brexit."
 
"It is important that the regulatory framework for the conduct of pharmacovigilance by the licensing authority and the UK MAHs is clearly set out following the departure of the UK from the EU's regulatory and scientific pharmacovigilance network," MHRA says in the 71-page guidance.
 
MHRA says that if the UK exits the EU without a negotiated withdrawal agreement in place the Human Medicines Regulations 2012 (HMR) statutory instrument 2012 No. 1916, which implemented the EU's Directive 2001/83/EC, will be further amended by the UK's exit regulations.
 
According to MHRA, guidance issued by the European Commission under Article 108a of 2001/83/EC "continues to apply" to both MHRA and UK MAHs until the UK publishes its own guidance on GVP.
 
MHRA further explains that in the interim that the UK licensing authority "may determine that specific provisions of [EU GVP] no longer apply in the UK or are subject to modification."
 
The guidance also sets out some aspects of EU GVP that will no longer apply to the UK or be modified from exit day on and notes that the guidance apply to the version of EU GVP that applied as of exit day and will be reconsidered as EU GVP is revised.
 
Specifically, MHRA says that the guidance outlines areas where equivalent legal requirements in the UK will supersede the application EU legal requirements for pharmacovigilance and that references to competent authorities will apply instead to the UK licensing authority "except where the guidance is describing the operation of the EU's regulatory and scientific pharmacovigilance network."
 
The agency also explains that the sections that will no longer apply to UK are generally ones that refer to operations of the EU network and the roles of EU agencies and committees, such as the European Medicines Agency (EMA) and its Pharmacovigilance Risk Assessment Committee (PRAC).
 
The bulk of the guidance goes through the various EU GVP modules and explains where text is modified or substituted. Sections of the guidance that are not mentioned are considered to be wholly applicable following a no-deal Brexit.
 
MHRA

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