These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”), which govern the arrangements, across the United Kingdom, for the licensing, manufacture, wholesale dealing and sale or supply of medicines for human use.

Regulations 3 and 4 of the 2012 Regulations, read with section 10 of the Medicines Act 196818, contain exemptions from the requirements to hold a manufacturer’s licence and a marketing authorisation that relate to final processing undertaken at the end of the medicines supply chain. Exemptions already exist that allow (amongst others) doctors, nurses and pharmacists to undertaken some final processing, subject to conditions. The new regulation 3A of the 2012 Regulations ensures that all professionally justified acts of preparation and assembly of a coronavirus vaccine may be undertaken by or under the supervision of a doctor, nurse or pharmacist, at any location, without precipitating the need for a manufacturer’s licence or marketing authorisation – provided those acts are done under NHS arrangements or arrangements as part of the medical services of Her Majesty’s Forces. It also allows for authorised medicinal products used for the reformulation of coronavirus vaccines (for example, diluents) to be re-assembled at the end of the medicines supply chain without the resultant products needing marketing authorisations in order to be supplied. Provision is also made to allow holders of wholesale dealer’s licences who do not have manufacturer’s licences to label coronavirus vaccines to take account of changes to the shelf life of the vaccines because of the thawing of the product. There is also a change in relation to the application of the packaging and package leaflet requirements of the 2012 Regulations to take account of these other changes. Regulation 3A of the 2012 Regulations ceases to have effect on 1st April 2022 (regulation 4).

Subject to various exceptions in Part 12 of the 2012 Regulations but by virtue of restrictions in that Part, prescription only medicines may only be sold or supplied in accordance with a prescription of, or administered parenterally by, a health care professional who is classed as an appropriate practitioner. The 2012 Regulations already provide for either or both of these Part 12 restrictions to be set aside by instruments known as Patient Group Directions (PGDs). Prior to these Regulations, PGDs issued under regulation 229 of the 2012 Regulations by a number of listed NHS bodies, or bodies exercising public health functions, could only set aside the first of these two restrictions – the limitation relating to prescriptions. These Regulations allow these PGDs also to set aside the second of these restrictions – the restriction relating to parenteral administration – until 1st April 2022 (regulation 5(a) and (d)). An additional amendment is made to ensure that this change cannot be construed as adding to the prescribing rights of appropriate practitioners who could not otherwise prescribe medicinal products for parenteral administration (regulation 5(b)).

Also, subject to various exceptions in Part 12 of the 2012 Regulations but by virtue of restrictions in that Part, prescription only medicines and pharmacy medicines must be sold or supplied, by or under the supervision of a pharmacist, on premises that are a registered pharmacy. These Regulations allow, until 1st April 2022, the PGDs permitted for persons lawfully conducting a retail pharmacy business by regulation 233 of the 2012 Regulations to set aside these restrictions if the PGD is for a medicinal product used for vaccination or immunisation against coronavirus or influenza and the other conditions in regulation 233 are also made out (regulation 8(b)).

In response to certain types of public health threats, the licensing authority under the 2012 Regulations may temporarily authorise the sale or supply of medicinal products without marketing authorisations. The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 made wide ranging provision in relation to such temporary authorisations, including adapting the provisions of the 2012 Regulations relating to PGDs and the advertising of medicinal products to accommodate them. These amendments were not taken into account, in error, when some of the same provisions were subject to further amendment as a consequence of changes made by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 to the Human Medicines (Amendment etc.) (EU Exit) Regulations 201919. These Regulations therefore make a number of consequential amendments to preserve the effect of the amendments made by the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 in relation to PGDs and advertising of medicines that were not reflected in the changes made by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (regulations 2, 5(c), 6, 7, 8(a) and 9 to 14).

Amendments to the Human Medicines Regulations 2012 are subject to the requirements of the Statutory Rules (NI) Order 1979 and the corresponding SI in respect of this Statutory Rule is S.I.1594/2020.