When Brexit happened in the UK on 31 January 2020, the regulatory picture changed with it. The MHRA (Medicines and Healthcare Regulatory Agency) was previously created to regulate UK medicines, medical devices, and blood products. However, amended EU regulations remain in place in the UK for dietary supplements. These specify the approved ingredients (listed in Annex I and II of EU Directive 2002/46/EC.)
We’ve already addressed how our software design serves the EU-qualified person and the Annex 11 requirements. It turns out that a qualified person’s role and qualifications will be retained in MHRA GMP.
Additionally, we’ve created several types of documentation (Electronic Batch Records, quality workflows, specifications, etc.) to support MHRA product inspections of all types, including an audit workflow for a preliminary dry run. This, and the built-in recording and traceability capabilities, will help expedite the various MHRA compliance reports.
Many of these capabilities can be used to provide composition data for MHRA Medicinal Products Reviews. Our InstantGMP PRO contains review candidate Electronic Batch Records (which can be completed Make to Order) as produced, formulated, tested, and approved, as well as specifications and applicable traceability, to organize and expedite the review process.
Looking further into how InstantGMP capabilities address the current regulatory positions in MHRA Guidance Note 8, the general trend is that for all types of products, not MHRA specified (tobacco cessation, topicals, CBD products, etc.), if it is for a medicinal purpose, it’s regulated as a medicine. For now, e-liquids and cosmetics are generally deemed not medicinal. However, we in the USA have already seen considerable interest in the Modernization of Cosmetics Regulation Act (MOCRA) at the FDA. Thus, some of these appendices might evolve over time for regulatory or (more likely) world commercial harmonization.
We’ll be watching and listening. Meanwhile, for inquiries, discussions, and more, just reach out to us. www.instantGMP.com
“Good Manufacturing Practice and Good Distribution Practice” www.gov.uk
“A Guide to What is a Medicinal Product”, MHRA Guidance Note 8, 3/2020