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The Human Medicines Regulations 2012

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PART 2U.K.Exemption from the restriction on supply of prescription only medicines

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Royal National Lifeboat Institution and certified first aiders of the Institution.1. All prescription only medicines1. The supply shall be only so far as is necessary for the treatment of sick or injured persons in the exercise of the functions of the Institution.
2. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement.2. All prescription only medicines.2. The supply shall be only so far as is necessary for the treatment of persons on the ship.
3. Persons authorised by licences granted under regulation 5 of the Misuse of Drugs Regulations 2001 M1 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002 M2 to supply a controlled drug.3. Such prescription only medicines, being controlled drugs, as are specified in the licence.3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
4. Persons employed or engaged in the provision of lawful drug treatment services.4. Ampoules of sterile water for injection that contain no more than 2ml of water each.4. The supply shall be only in the course of provisions of lawful drug treatment services.

[F14a 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;

(b) a local authority;

(c) Public Health England; or

(d) Public Health Agency.

4a A prescription only medicine for parenteral administration containing naloxone hydrochloride but no other substance that is classified as a product available on prescription only.4a 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.]
5. Persons requiring prescription only medicines 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.5. Such prescription only medicines as may be specified in the relevant enactment.

5. The supply shall be—

(a) for the purpose of enabling them to comply with any requirements made by or in pursuance of any such enactment, and

(b) subject to such conditions and such circumstances as may be specified in the relevant enactment.

6. Persons operating an occupational health scheme.6. Prescription only medicines sold or supplied to a person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.

6. The supply of the prescription only medicine shall be—

(a) in the course of operating an occupational health scheme, and

(b) made by—

(i) a doctor, or

(ii) a registered nurse acting in accordance with the written directions of a doctor as to the circumstance in which such medicines are to be used in the course of an occupational health scheme.

7. The operator or commander of an aircraft.7. Prescription only medicines which are not for parenteral administration and which have been sold or supplied to an operator or commander of an aircraft in response to an order in writing signed by a doctor.7. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be 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 on the aircraft.
8. Persons employed as qualified first-aid personnel on off-shore installations.8. All prescription only medicines.8. The supply shall be only so far as is necessary for the treatment of persons on the installation.
9. 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.9. Prescription only medicines supplied to a person specified in column 1 in response to an order in writing signed by a doctor.9. 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.
10. Persons (“P”) who are members of Her Majesty's armed forces.10. All prescription only medicines.

10. The supply shall be—

(a) in the course of P undertaking any function as a member of Her Majesty's armed forces; and

(b) where P is satisfied that it is not practicable for another person who is legally entitled to supply a prescription only medicine to do so; and

(c) only in so far as is necessary—

(i) for the treatment of a sick or injured person in a medical emergency, or

(ii) to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not supplied.

[F211. A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine. 11. A prescription only medicinal product comprising an inhaler containing salbutamol.

11. 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.]

[F312 Registered midwives.

12 Prescription only medicines for parenteral administration that contain–

(a) Diamorphine,

(b) Morphine,

(c) Pethidine hydrochloride.

12 The supply shall be only in the course of their professional practice.]

Textual Amendments

F1Words in Sch. 17 Pt. 2 added (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 10(2) and words in Sch. 17 Pt. 2 added (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 10(2)

F2Words in Sch. 17 Pt. 2 added (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 27(3) and words in Sch. 17 Pt. 2 added (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 27(3)

F3Words in Sch. 17 Pt. 2 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(3) and words in Sch. 17 Pt. 2 inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(3)

Marginal Citations

M1S.I. 2001/3998, to which there are amendments that are not relevant.

M2S.R. 2002 No. 1, to which there are amendments that are not relevant.

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