Part 2: Human Medicines Chapter 1: Regulations Section 7: Emergencies
Section 7 allows amending and supplementary regulations to be made under section 2(1) about the relaxation of regulatory requirements relating to medicines in circumstances where there is a need to alleviate a threat of serious harm to the health of the general public or a section of the public. The Covid-19 pandemic would be an example of such circumstances.
	By way of example, the provisions could be made to facilitate stocks of medicines to be shared between persons who do not hold wholesale dealer’s authorisations, such as doctors’ surgeries, for quicker distribution within the community. Or it could allow for larger packs of pills to be split into smaller packs where necessary in an emergency by persons who do not hold the correct authorisation to do so and who are not otherwise exempt from the requirement to hold such an authorisation before doing so.
	Subsections (2) and (3) provide that the relaxing of a regulatory requirements can be made subject to conditions. Conditions may be found in regulations or a time-limited protocol that is published by the Secretary of State and the Department of Health in Northern Ireland. For example, the regulations could allow for the supply of medicines without a prescription, or otherwise than from a registered pharmacy, in circumstances that pose a serious risk to human health provided the supply is in accordance with a protocol that sets out specific conditions, such as the medicinal products which may be supplied or the criteria under which a person is to be eligible for treatment. Conditions can be important safeguards and may need to be bespoke. The use of protocols may be the most effective means to communicate the applicable conditions to healthcare and other professions accustomed to operating within the comprehensive regulatory regime governing medicines.