Explanatory note

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.

Regulation 3 amends regulation 3 of the 2012 Regulations to enable pharmacists to prepare or assemble medicines for a patient without a manufacturer’s licence. The existing arrangements for preparation or assembly by pharmacists in regulation 4 of the 2012 Regulations will continue to apply where someone other than the pharmacist takes the treatment decision to supply or administer the medicine. Regulation 15 amends Schedule 26 to the 2012 Regulations consequentially to specify the labelling requirements that would apply in this circumstance.

Regulation 4 amends regulation 3A of the 2012 Regulations, so that it is a permanent provision that extends to all vaccines against infectious diseases. However, regulation 3A of the 2012 Regulations is now limited only to assembly by holders of a wholesale dealer’s licences to take account of changes to shelf life and no longer applies to acts of preparation and assembly undertaken by or under the supervision of a doctor, nurse or pharmacist.

Regulation 6 amends regulation 19 of the 2012 Regulations, so that it is a permanent provision that extends to all vaccines against infectious diseases. Regulation 19 of the 2012 Regulations provides for certain exemptions from the requirement to hold a wholesale dealer’s licence, and paragraphs (4A) to (4F) of that regulation (which includes new paragraphs added by regulation 6) permit distribution of stocks of vaccinations between providers of vaccination services without the need for such a licence. Conditions are imposed to ensure the exceptional use of this exemption, which include that the situation must be such that there is an urgent public health need, there is no alternative medicine capable of meeting that need, and there is no alternative route for the patient to receive the product.

Subject to various exceptions in Part 12 of the 2012 Regulations, 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. Regulation 233 of the 2012 Regulations provides that persons lawfully conducting a retail pharmacy business are exempted from this restriction if the supply or administration to the patient is in accordance with a patient group direction (amongst other conditions). Regulation 8 amends regulation 233 of the 2012 Regulations to extend the exemption to cover all vaccines against infectious diseases.

Regulation 9 introduces a new regulation 235A in the 2012 Regulations, which exempts the supply or administration of certain vaccines from the requirements relating to the supply of medicines under regulations 214, 220 and 221, where the administration to the patient is in accordance with a vaccine group direction produced by a public health agency (as defined in the regulation) and subject to other pre-conditions as outlined in the regulation. Regulation 7 introduces a new definition for a vaccine group direction. Regulation 13 makes consequential amendments to Schedule 16 to the 2012 Regulations.

Regulation 10 removes regulation 247A of the 2012 Regulations (as this is replaced by the above inserted regulation 235A of the 2012 Regulations). Regulations 11 and 12 make consequential amendments as a result of the removal of regulation 247A of the 2012 Regulations and the insertion of the new regulation 235A of the 2012 Regulations.

Regulation 14 amends Schedule 17 to the 2012 Regulations to enable occupational health vaccinators to administer any vaccine as part of an occupational health scheme (which is not restricted to a scheme operated by the NHS). Regulation 5 amends the definition of occupational health vaccinator to align with the classes of individuals specified in Part 4 of Schedule 16 to the 2012 Regulations.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen. A de minimis assessment is available from the Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU and is published with the explanatory memorandum alongside this instrument on www.legislation.gov.uk.