The Human Medicines Regulations 2012 (SI 2012/1916) (the “Regulations”) came into force on 14 August, as a plan of the Medicines and Healthcare products Regulatory Agency (MHRA) to consolidate and modernize the medicines legislation in England and Wales (a copy of the Regulations is available here).
The Regulations replace most of the Medicines Act 1968 and over 200 statutory instruments, significantly simplifying the interpretation of the law and ensuring that it reflects current practice.
Envisaging that the legislative framework in England and Wales remains fit for purpose and easy to understand for the industry, the Regulations also transpose the latest European Directive 2010/84/EU (introducing a stronger and more balanced regime for monitoring the safety of medicinal products) and introduce some small policy changes in order to reduce the regulatory burden on businesses, including the following:
- removal of statutory warnings for packaging of over the counter products (other than paracetamol);
- improving the process for review hearings for MHRA licensing decisions;
- updating of a number of exemptions from the usual restrictions allowing health professionals and others to sell, supply and/or administer medicines;
- optimizing the process for using patient group directions;
- removing the requirement for the pharmacist to contact the prescriber prior to making certain changes to a prescription, enabling pharmacists to use their expertise and professional judgment to provide medicines to patients in a more efficient way; and
- repealing section 10(7) of the Medicines Act 1968, which previously allowed pharmacists to wholesale medicines without a wholesale dealer’s licence (WDL) under certain circumstances.
The MHRA has produced a “Table of Origins” as well as a brief overview of each Part of the Regulations intended to assist users (a copy of which is available here).
The industry has backed the changes and seems confident that the interpretation of the consolidated legislation will be much clearer going forward. Professor Sir Kent Woods, the MHRA Chief Executive, claimed that the Regulations will “simplify 40 years” of much fragmented and obsolete legislation. Coinciding with the introduction of the Regulations and to reflect the latest developments, the Prescription Medicines Code of Practice Authority (PMCPA) has also published an updated pharmaceutical industry code of conduct, covering the promotion of medicines and the information provided to the public of prescription only medicines (a copy of which is available here). Additionally, as trading without a WDL may risk criminal prosecution, the National Pharmacy Association (NPA) has too published guidance to ensure that the pharmacists’ current practices are permissible within the Regulations (see www.npa.co.uk).
For more information or advice please contact Anna Feros.