The Human Medicines Regulations 2012

PART 5 U.K. Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products

Column 1	Column 2	Column 3
Persons exempted	Medicinal products to which exemption applies	Conditions
1. Royal National Lifeboat Institution and certificated first aiders of the Institution.	1. All medicinal products.	1. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
2. British Red Cross Society and certificated first aid and certificated nursing members of the Society.	2. All pharmacy medicines and all medicinal products on a general sale list.	2. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
3. St John Ambulance Association and Brigade and certificated first aid and certificated nursing members of the Association and Brigade.	3. All pharmacy medicines and all medicinal products on a general sale list.	3. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
4. St. Andrew's Ambulance Association and certificated first aid and certificated nursing members of the Association.	4. All pharmacy medicines and all medicinal products on a general sale list.	4. The supply shall be only so far as is necessary for the treatment of sick and injured persons.
5. Order of Malta Ambulance Corps and certificated first aid and certificated nursing members of the Corps.	5. All pharmacy medicines and all medicinal products on a general sale list.	5. The supply shall be only so far as is necessary for the treatment of sick or injured persons.
6. Persons authorised by licences granted under regulation 5 of the Misuse of Drugs Regulations 2001 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.	6. Such prescription only medicines and such pharmacy medicines as are specified in the licence.	6. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
7. Persons employed or engaged in the provision of lawful drug treatment services.	7. Ampoules of sterile water for injection that contain no more than 5ml of water each.	7. The supply shall be only in the course of provision of lawful drug treatment services.
[F1 7a Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies– (a) an NHS body; (d) a local authority; (c) Public Health England; or (d) Public Health Agency.	7a [F2 A medicinal product containing naloxone hydrochloride but no other substance that is classified as a product available only on prescription or as a product available only from a pharmacy.]	7a The supply shall be only in the course of provisions of lawful drug treatment services and only where required for the purpose of saving life in an emergency.]
8. Persons requiring medicinal products for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.	8. Such prescription only medicines and such pharmacy medicines as may be specified in the relevant enactment and medicinal products on a general sale list.	8. The supply shall be— (a) for the purpose of enabling compliance with any requirement made by or in pursuance of any such enactment, and (b) subject to such conditions and in such circumstances as may be specified in the relevant enactment.
9. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement.	9. All medicinal products.	9. The supply shall be only so far as is necessary for the treatment of persons on the ship.
10. Persons operating an occupational health scheme.	10. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines as are sold or supplied to a person operating an occupational health scheme in response to an order signed by a doctor or a registered nurse.	10. (a) The supply shall be in the course of an occupational health scheme. (b) The individual supplying the medicinal product, if not a doctor, shall be— (i) a registered nurse, and (ii) where the medicinal product in question is a prescription only medicine, acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of an occupational health scheme.
[F3 10a. An NHS body or a local authority operating an occupational health scheme and occupational health vaccinators employed or engaged by them.	10b. A prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (of any type) sold or supplied to a person operating an occupational health scheme mentioned in entry 10a in response to an order in writing signed by a doctor or an occupational health vaccinator.	10c. The supply of the medicine is in the course of an occupational health scheme mentioned in entry 10a, and the individual supplying the medicine is, if not a doctor, an occupational health vaccinator acting in accordance with the written directions of a doctor as to the circumstances in which such medicines are to be used.]
11. Persons carrying on the business of a school providing full-time education.	11. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.	11. The supply shall be— (a) in the course of a school dental scheme, and (b) if to a child under 16 only where the parent or guardian of that child has consented to such supply.
12. Health authorities or Primary Health Trusts.	12. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.	12. The supply shall be in the course of— (a) a pre-school dental scheme, and the individual supplying the medicinal product shall be a registered nurse, or (b) a school dental scheme, and if to a child under 16 only where the parent or guardian of that child has consented to such supply.
13. The operator or commander of an aircraft.	13. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of an aircraft in response to an order in writing signed by a doctor.	13. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and, in the case of a prescription only medicine, shall be in accordance with the written instructions of a doctor as to the circumstances in which the prescription only medicines of the description in question are to be used on the aircraft.
14. Persons employed as qualified first-aid personnel on offshore installations.	14. All medicinal products.	14. The supply shall be only so far as is necessary for the treatment of persons on the installation.
15. A prison officer.	15. All medicinal products on the general sale list.	15. The supply shall only be so far as is necessary for the treatment of prisoners.
16. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee.	16. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are sold or supplied to a person specified in column 1 of this paragraph in response to an order in writing signed by a doctor.	16. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.
17. Her Majesty's armed forces.	17. All medicinal products.	17. The supply shall be only so far as is necessary for the treatment of a sick or injured person or the prevention of ill-health.
[F4 18. A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine.	18. A prescription only medicinal product comprising an inhaler containing salbutamol.	18. The supply shall be— (a) in the course of P carrying on the business of a school; (b) where supply is to a pupil at that school who is known to suffer from asthma; and (c) where the pupil requires the medicinal product in an emergency.]
[F5 19. Persons supplying medicinal products under an off-site emergency plan prepared under the [F6 Radiation (Emergency Preparedness and Public Information) Regulations 2019].]	[F5 19. Pharmacy medicines which contain any of the following substances but no other active ingredient— (a) Potassium Iodide; (b) Potassium Iodate.]	[F5 19. The supply shall be— (a) in accordance with the off-site emergency plan; and (b) only in the event that a radiation emergency has occurred or an event has occurred which could reasonably be expected to lead to a radiation emergency.]
[F5 20. A person or body listed in Part 1 or 2 of Schedule 1 to the Civil Contingencies Act 2004.]	[F5 20. Pharmacy medicines which contain any of the following substances but no other active ingredient— (a) Potassium Iodide; (b) Potassium Iodate.]	[F5 20. The supply shall only be in response to the occurrence, or likely occurrence, of one of the following events— (a) an emergency within the meaning of section 1 of the Civil Contingencies Act 2004; (b) a [F7 radiation] emergency within the meaning of regulation 24 of the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009.]

Textual Amendments

F1 Words in Sch. 17 Pt. 5 added (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 10(3) and words in Sch. 17 Pt. 5 added (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 10(3)

F2 Words in Sch. 17 Pt. 5 substituted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 18(b) and words in Sch. 17 Pt. 5 substituted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 18(b)

F3 Words in Sch. 17 Pt. 5 inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 32(4) and words in Sch. 17 Pt. 5 inserted (N.I.) (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 32(4)

F4 Words in Sch. 17 Pt. 5 added (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 27(4) and words in Sch. 17 Pt. 5 added (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 27(4)

F5 Words in Sch. 17 Pt. 5 inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 12(2) and words in Sch. 17 Pt. 5 inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 12(2)

F6 Words in Sch. 17 Pt. 5 substituted (E.W.S.) (22.5.2019) by The Radiation (Emergency Preparedness and Public Information) Regulations 2019 (S.I. 2019/703), reg. 1(1), Sch. 10 para. 10(3) (with reg. 3)

F7 Word in Sch. 17 Pt. 5 substituted (21.4.2019) by The Carriage of Dangerous Goods (Amendment) Regulations 2019 (S.I. 2019/598), regs. 1, 10