Post-Implementation Review of the Human Medicines Regulations 2012
Published: 09/05/24
Consultation Response: Post-implementation review of the Human Medicines Regulations 2012
Introduction
The MHRA have a statutory duty to carry out regular reviews of specific parts of the Human Medicines Regulations (2012). The first and only review to date was carried out in 2017 – the final report of this review can be found here. Although the same areas of the regulations are being reviewed as in 2017, we are now in a post-Brexit era, and there have been some amendments to the regulations in the intervening years.
To inform the next report, the MHRA have published a questionnaire. Our response is included below – please note that not all areas are relevant to community pharmacy, so some questions have not been answered – notably in the Falsified Medicines Directive section, which is not asking about the community pharmacy element of the regulations.
Section 1: Pharmacovigilance
The HMRs implemented national requirements of EU PV legislation, Directive 2010/84/EU, key objectives of which included:
Rationalising EU decision-making on drug safety to deliver measures that are equally implemented across the community.
Strengthened PV systems, allowing continuous improvement while reducing administrative burden.
Greater communication to increase understanding and trust of patients and health professionals.
Since the last Review, regulations have been amended to reflect the UK’s Exit from the EU and the requirements with regards to the supply of human medicines to Northern Ireland. Amendments include changes that apply to UK marketing authorisation holders regarding PV practices.
Section 2: Cross Border Prescriptions
Objective: The HMRs, as amended in 2019, have enabled dispensing healthcare professionals to dispense certain prescriptions written outside the UK if it was written by a member of a listed profession and written in a listed country, and otherwise meets the requirements in the HMRs.
Section 3 - Sale and Supply: Exemptions for certain collection and delivery arrangements
Exemptions for certain collection and delivery arrangements (regulations 248(1)(a) and (2)(a)
“Collection and delivery arrangement” means an arrangement whereby a retail pharmacy may take or send a medicine to be supplied in accordance with a prescription given by a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber, paramedic independent prescriber or optometrist independent prescriber for collection from premises other than a registered pharmacy and which are capable of being closed by the occupier to exclude the public.
Section 4 – Sale and Supply: Repeal of Section 10(7)
Repeal of Section 10(7) [regulation 349 in so far as it repeals section 10(7) of the Medicines Act 1968]
Section 10(7) of the Medicines Act 1968 provided an exemption in UK law for the requirement for a pharmacist to hold a Wholesale Dealer’s Licence if the wholesale dealing formed only a minor portion of their business at that pharmacy. The repeal of section 10(7) was necessary to comply with EU legislation, in particular articles 77(1) and 77(2) of Directive 2001/83/EC which required anyone undertaking wholesale dealing activities to hold an authorisation.
In doing so, the objective of the HMRs was to:
Take account of the UK’s National Health Service (which is relatively unique among Member States as a health service open to all without the need for private insurance).
Protect patients by assuring the security of the supply chain.
Preserve continued supplies of medicines above all other concerns.
Minimise extra regulatory cost and administrative burden, particularly for the NHS.
Section 5: Falsified Medicines
Implementation of the Falsified Medicines Directive (FMD)
Provisions: Chapters 1, 3 and 4 of Part 3; Part 12A; Regulations - 18(6); - 37(4)(b), (5), (6) and (12); 43(5), (6)(a) and (d), 7(c)(iii) and (vii), (8) and (10) to (14); 44(2) to (6), 110(8A); 135(10A); 330(1) and (2); Schedule 5 paragraphs 1(1)(b) to (d), (2)(b) to (d), 3(11)(b)(vi) to (viii), 5(2)(f) to (h) and Schedule 7A
Objective: The EU FMD (2011/62/EU) was adopted in the UK in 2013 with the final part of the Directive, the ‘safety features’ coming into force in 2019.
It was applied to maximise the protection of the legal supply chain in the EU against infiltration of falsified medicinal products, i.e. to ensure that for all practical purposes the possibility that medicinal products purchased in the legal supply chain in the EU are counterfeit can be practically ruled out. Measures included:
Tougher rules on import of active pharmaceutical ingredients
Strengthened record-keeping requirements for wholesale distributors.
Many of the provisions, which relate to FMD, built on existing obligations on those who trade in medicines (manufacturer and wholesale dealers). The legislation also extended to previously unregulated operators such as those engaged in brokering the sale and supply of medicinal products.
Since the UK has exited the EU, the ‘safety features’ (serialisation) part of the FMD ceased to have effect in Great Britain from 31 December 2020 and will be disapplied in Northern Ireland when the Windsor Framework takes effect on 1 January 2025.
We are therefore not looking for input on the implementation of the ‘safety features’ and verification provisions, given that these will not apply in any part of the UK from 1 Jan 2025. We are looking for input on the other changes to the HMRs that were originally made as a result of FMD, and remain in place.
Section 6: General