The Human Medicines Regulations 2012

PART 3 U.K. Exemptions from the restriction on administration of prescription only medicines

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Registered chiropodists or podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.	1. Prescription only medicines for parenteral administration that contain— (a) Adrenaline, (b) Bupivacaine hydrochloride, (c) Bupivacaine hydrochloride with adrenaline where the maximum strength of adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride, (d) Levobupivacaine hydrochloride, (e) Lidocaine hydrochloride, (f) Lidocaine hydrochloride with adrenaline where the maximum strength of adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride, (g) Mepivacaine hydrochloride, (h) Methylprednisolone, (i) Prilocaine hydrochloride, (j) Ropivacaine hydrochloride.	1. The administration shall only be in the course of their professional practice and where the medicine includes a combination of substances in column 2, those substances shall not have been combined by the chiropodist or podiatrist.
2. Registered midwives and student midwives.	2. Prescription only medicines for parenteral administration containing any of the following substances but no other substance that is classified as a product available on prescription only— (a) Adrenaline, (b) Anti-D immunoglobulin, (c) Carboprost, (d) Cyclizine lactate, (e) Diamorphine, (f) Ergometrine maleate, (g) Gelofusine, (h) Hartmann's solution, (i) Hepatitis B vaccine, (j) Hepatitis immunoglobulin, (k) Lidocaine hydrochloride, (l) Morphine, (m) Naloxone hydrochloride, (n) Oxytocins, natural and synthetic, (o) Pethidine hydrochloride, (p) Phytomenadione, (q) Prochloperazine, (r) Sodium chloride 0.9%.	2. The medicine shall— (a) in the case of Lidocaine and Lidocaine hydrochloride, be administered only while attending on a woman in childbirth, and (b) where administration is— (i) by a registered midwife, be administered in the course of their professional practice; (ii) by a student midwife— (aa) be administered under the direct supervision of a registered midwife; and (bb) not include Diamorphine, Morphine or Pethidine hydrochloride.
3. Persons who are authorised as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations 2001 M1 or, regulations 8(3) or 9(3) of the Misuse of Drugs Regulations (Northern Ireland) 2002 M2 , to supply a controlled drug by way of administration only.	3. Prescription only medicines that are specified in the group authority.	3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority.
4. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement.	4. All prescription only medicines that are for parenteral administration.	4. The administration shall be only so far as is necessary for the treatment of persons on the ship.
5. Persons operating an occupational health scheme.	5. Prescription only medicines that are for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.	5. The prescription only is administered in the course of an occupational health scheme, and the individual administering the medicine is— (a) a doctor, or (b) a registered nurse 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.
[F1 5a. An NHS body or a local authority operating an occupational health scheme and occupational health vaccinators employed or engaged by them.	5b. 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 5a in response to an order in writing signed by a doctor or an occupational health vaccinator.	5c. The administration of the medicine is in the course of an occupational health scheme mentioned in entry 5a, and the individual administering 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.]
6. The operator or commander of an aircraft.	6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.	6. The administration 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 the doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons employed as qualified first-aid personnel on off-shore installations.	7. All prescription only medicines that are for parenteral administration.	7. The administration shall be only so far as is necessary for the treatment of persons on the installation.
8. Persons who are registered paramedics.	8. The following prescription only medicines for parenteral administration— (a) Diazepam 5 mg per ml emulsion for injection, (b) Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion, (c) medicines containing the substance Ergometrine Maleate 500 mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient, (d) prescription only medicines containing one or more of the following substances, but no other active ingredient— (i) Adrenaline Acid Tartrate, (ii) Adrenaline hydrochloride, (iii) Amiodarone, (iv) Anhydrous glucose, (v) Benzlypenicillin, (vi) Compound Sodium Lactate Intravenous Infusion (Hartmann's Solution), (vii) Ergometrine Maleate, (viii) Furosemide, (ix) Glucose, (x) Heparin Sodium, (xi) Lidocaine Hydrochloride, (xii) Metoclopramide, (xiii) Morphine Sulphate, (xiv) Nalbuphine Hydrochloride, (xv) Naloxone Hydrochloride, (xvi) Ondansetron (xvii) Paracetamol, (xviii) Reteplase, (xix) Sodium Chloride, (xx) Streptokinase, (xxi) Tenecteplase.	8. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.
9. Persons who hold the advanced life support provider certificate issued by the Resuscitation Council (UK).	9. The following prescription only medicines for parenteral administration — (a) Adrenaline 1:10,000 up to I mg; and (b) Amiodarone.	9. The administration shall be only in an emergency involving cardiac arrest, and in the case of adrenaline the administration shall be intravenous only.
[F2 10. Persons (“P”) who are members of Her Majesty’s armed forces.	10. All prescription only medicines.	10. The administration 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 administer 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 an 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 administered.]
[F3 11 A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine.	11 A prescription only medicine comprising an auto-injector containing adrenaline.	11 The administration shall be— (a) in the course of P carrying on the business of a school; (b) where administration is to a pupil at that school who is known to be at risk of anaphylaxis; and (c) where the pupil requires the medicinal product in an emergency.]

Textual Amendments

F1 Words in Sch. 17 Pt. 3 inserted (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(3), 32(3) and words in Sch. 17 Pt. 3 inserted (N.I.) (17.10.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(3), 32(3)

F2 Words in Sch. 17 Pt. 3 added (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 11 and words in Sch. 17 Pt. 3 added (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 11

F3 Words in Sch. 17 Pt. 3 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(3) and words in Sch. 17 Pt. 3 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(3)

Marginal Citations

M1 S.I. 2001/3998 as amended by S.I. 2007/2154. There are other amendments that are not relevant.

M2 S.R. 2002 No. 1, as amended by S.R. 2007 No. 348. There are other amendments that are not relevant.