Section 26: Requirements about supervision
130.Section 26 relates to the requirements in the Medicines Act relating to the supervision of certain activities by pharmacists.
131.Section 26(1) amends section 10 of the Medicines Act. Under the Medicines Act a licence is required to manufacture or supply medicinal products; section 10 of the Medicines Act provides for various exemptions from the licensing requirements of the Medicines Act where, in certain circumstances, a pharmacist, or a person acting under the supervision of a pharmacist, prepares, assembles, dispenses or supplies a medicine. Section 26(1) inserts new subsections in section 10. These confer on the “Health Ministers” (i.e. the Secretary of State for Health and the Northern Ireland Department for Health, Social Services and Public Safety) a power to make regulations prescribing conditions which must be complied with if that activity is to be considered as done under the supervision of a pharmacist. If any of the prescribed conditions apply to that activity and are met, that will be sufficient for the activity in question to be considered as done under supervision. In addition, the new powers will extend to prescribing conditions in relation to “remote supervision” – i.e. where the pharmacist supervises an activity without being present at the pharmacy (e.g. by using a video link). If no such conditions are prescribed, the pharmacist cannot supervise remotely. The intention is that the regulations will clarify the pharmacist’s obligations to supervise.
132.Section 26(2) amends section 52 of the Medicines Act. Section 52 of the Medicines Act imposes conditions on the sale or supply of any medicine which is not a “general sale list” medicine; in particular that any transaction for the sale or supply of a medicine to a customer must be carried out by, or under the supervision of, a pharmacist. A general sale list medicine is one which may be sold in retail premises which can be secured so as to exclude the public, but which are not a pharmacy (e.g. a supermarket or newsagent shop). Section 26(2) makes amendments to section 52 of the Medicines Act, identical to those for section 10; i.e. enabling the Health Ministers to make regulations relating to the requirements for supervision by a pharmacist.
