The Human Medicines (Amendment) Regulations 2014

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”) in order to implement—

• Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (“the cross-border Directive”);

• Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another member State (“Directive 2012/52/EU”).

These Regulations correct two provisions that were not properly consolidated in the 2012 Regulations because of an error and they also clarify a provision that was reported by the House of Lords and the House of Commons Joint Committee on Statutory Instruments (JCSI).

Further to the reports of the JCSI on regulation 165 of the 2012 Regulations (Ninth Report of Session 2012-13 and Eleventh Report of Session 2013-14) and the response given by the Department of Health in reply, regulation 3 clarifies the wording of this regulation to make it clearer that the provision does not preclude the licensing authority from determining that a product is a medicinal product under other provisions in those Regulations.

These Regulations introduce new provisions into the 2012 Regulations in order to implement Article 11 of the cross-border Directive on the recognition of prescriptions issued in another member State. In particular—

• regulation 4(a) substitutes a definition of “EEA health professional” that accords with provisions in Article 3 of the cross-border Directive. It also inserts a definition of “product subject to special medical prescription”;

• regulation 4(b) designates certain controlled drugs as products subject to a special medical prescription so that such products do not need to be dispensed under a prescription issued by an EEA member State;

• regulation 5 substitutes certain references to “controlled drugs” with references to “product subject to special medical prescription”.

These Regulations also insert a new provision into and amend two existing provisions of the 2012 Regulations in order to implement the requirements for prescriptions to contain certain information in accordance with the Annex to Directive 2012/52/EU. In particular—

• regulation 6 inserts a new provision that requires prescriptions issued in the UK for dispensing in another EEA State to contain certain information;

• regulation 7 amends existing provisions for incoming EEA prescriptions so that they accord with the new requirements;

• regulation 8 amends the requirements for incoming electronic EEA prescriptions.

Regulation 9 amends the 2012 Regulations to ensure that the new provisions on incoming and outgoing EEA prescriptions are subject to a review by the Secretary of State.

Regulation 10 amends the definition of controlled drugs to clarify that this relates to the definition of controlled drugs in the Misuse of Drugs Act 1971.

Regulation 11 inserts a provision that should have been consolidated in the 2012 Regulations whereby members of Her Majesty’s armed forces are able to administer prescription only medicines in some emergency circumstances.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on private, public or voluntary sectors is foreseen.