The Human Medicines Regulations 2012

[F1 PART 4 U.K. Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products

Textual Amendments

F1 Words 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)

Column 1	Column 2	Column 3
Persons exempted	Medicinal products to which exemption applies	Conditions
1. Registered chiropodists and podiatrists.	1. Medicinal products on a general sale list which are for external use and are not veterinary drugs and the following pharmacy medicines for external use— (a) Potassium permanganate crystals or solution; (b) ointment of heparinoid and hyaluronidase; and (c) products containing, as their only active ingredients, any of the following substances, at a strength, in the case of each substance, not exceeding that specified in relation to that substance— (i) 9.0 per cent Borotannic complex (ii) 10.0 per cent Buclosamide (iii) 3.0 per cent Chlorquinaldol (iv) 1.0 per cent Clotrimazole (v) 10.0 per cent Crotamiton (vi) 5.0 per cent Diamthazole hydrochloride (vii) 1.0 per cent Econazole nitrate (viii) 1.0 per cent Fenticlor (ix) 10.0 per cent Glutaraldehyde (x) 1.0 per cent Griseofulvin (xi) 0.4 per cent Hydrargaphen (xii) 2.0 per cent Mepyramine maleate (xiii) 2.0 per cent Miconazole nitrate (xiv) 2.0 per cent Phenoxypropan-2-ol (xv) 20.0 per cent Podophyllum resin (xvi) 10.0 per cent Polynoxylin (xvii) 70.0 per cent Pyrogallol (xviii) 70.0 per cent Salicylic acid (xix) 1.0 per cent Terbinafine (xx) 0.1 per cent Thiomersal.
2. Registered chiropodists and podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines in column 2.	2. (a) The following prescription only medicines— (i) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight, (ii) Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in the lacquer does not exceed 5 per cent by weight in volume, (iii) Amoxicillin, (iv) Co-Codamol, (v) Co-dydramol 10/500 tablets, (vi) Codeine Phosphate, (vii) Erythromycin, (viii) Flucloxacillin, (ix) Silver Sulfadiazine, (x) Tioconazole 28%, (xi) Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight; and	2. The sale or supply shall be only in the course of their professional practice, and the medicinal product must have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied.
	(b) Ibuprofen, other than preparations of ibuprofen which are prescription only medicines.
3. Registered optometrists.	3. All medical products on a general sale list, all pharmacy medicines and prescription only medicines which are not for parenteral administration and which— (a) are eye drops and are prescription only medicines by reason only that they contain not more than— (i) 30.0 per cent Sulphacetamide Sodium, or (ii) 0.5 per cent Chloramphenicol, or (b) are eye ointments and are prescription only medicines by reason only that they contain not more than— (i) 30.0 per cent Sulphacetamide Sodium, or (ii) 1.0 per cent Chloramphenicol, or (c) are prescription only medicines by reason only that they contain any of the following substances— (i) Cyclopentolate hydrochloride, (ii) Fusidic acid, (iii) Tropicamide.	3. The sale or supply shall be only— (a) in the case of medicinal products on a general sale list and pharmacy medicines, in the course of their professional practice; (b) in the case of prescription only medicines, in the course of their professional practice and in an emergency.
4. Additional supply optometrists.	4. Medicinal products which are prescription only medicines by reason only that they contain any of the following substances— (a) Acetylcysteine, (b) Atropine sulphate, (c) Azelastine hydrochloride, (d) Diclofenac sodium, (e) Emedastine, (f) Homotropine hydrobromide, (g) Ketotifen, (h) Levocabastine, (i) Lodoximide, (j) Nedocromil sodium, (k) Olopatadine, (l) Pilocarpine hydrochloride, (m) Pilocarpine nitrate, (n) Polymyxin B/bacitracin, (o) Polymyxin B/trimethoprim, (p) Sodium Cromoglycate.	4. The sale or supply shall be only in the course of their professional practice and only in an emergency.
5. Holders of manufacturer's licences where the licence in question contains a provision that the licence holder shall manufacture the medicinal product to which the licence relates only for a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgement as to the treatment required.	5. Medicinal products on a general sale list which are for external use and are not veterinary drugs and pharmacy medicines which are for external use in the treatment of hair and scalp conditions and which contain any of the following— (a) not more than 5.0 per cent of Boric acid, (b) Isopropyl myristate or Lauryl sulphate, (c) not more than 0.004 per cent Oestrogens, (d) not more than 1.0 per cent of Resorcinol, (e) not more than 3.0 per cent of Salicylic acid, (f) not more than 0.2 per cent of Sodium pyrithione.	5. The licence holder shall sell or supply the medicinal product in question only to a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgement as to the treatment required.
6. Persons selling or supplying medicinal products to universities, other institutions concerned with higher education or institutions concerned with research.	6. All medicinal products.	6. The sale or supply shall be— (a) Subject to the presentation of an order signed by the principal of the institution concerned with education or research or the appropriate head of department in charge of the specified course of research stating— (i) the name of the institution for which the medicinal product is required, (ii) the purpose for which the medicinal product is required, and (iii) the total quantity required, and (b) for the purposes of the education or research with which the institution is concerned.
7. Persons selling or supplying medicinal products to organisations for research purposes.	7. All medicinal products.	7. The sale or supply is only for the purposes of research and shall be— (a) subject to the presentation of an order signed by the representative of the organisation concerned stating— (i) who requires the medicine, (ii) the purposes for which it is required, (iii) the quantity required, and (iv) the purposes of the research with which the organisation is concerned; and (b) not for administration to humans.
8. Persons selling or supplying medicinal products to any of the following— (a) a public analyst appointed under section 27 of the Food Safety Act 1990 or under article 27 of the Food Safety (Northern Ireland) Order 1991; (b) an agricultural analyst appointed under section 67 of the Agriculture Act 1970 M1 , (c) a person duly authorised by an enforcement authority under regulations 325 to 328, (d) a sampling officer within the meaning a sampling officer within the meaning of Schedule 31.	8. All medicinal products.	8. The sale or supply is in connection with the exercise of any statutory function carried out by any person listed in sub-paragraphs (a) to (d) of column 1 provided that— (a) the medicinal products are requested on an order signed by or on behalf of a person listed in sub-paragraph (a) to (d) of column 1, and (b) the order gives— (i) the status of the person signing it, (ii) the amount of medicinal product required.
9. Holders of a [F2 UK marketing authorisation, EU marketing authorisation], a certificate of registration or a manufacturer's licence.	9. Medicinal product referred to in the [F2 UK marketing authorisation, EU marketing authorisation], certificate of registration or manufacturer's licence.	The sale or supply shall be only— (a) to a pharmacist, (b) so as to enable that pharmacist to prepare an entry relating to the medical product in question in a tablet or capsule identification guide or similar publication, and (c) of no greater quantity than is reasonably necessary for that purpose.
10. Registered dispensing opticians.	10. Pharmacy medicines for external use containing chloramphenicol at a strength not exceeding— (a) 0.5 per cent in eye drops; (b) 1 per cent in ointment.	10. The sale or supply shall only be in the course of their professional practice.
[F3 11. Operator or commander of an aircraft.	11. All medicinal products on a general sale list.	11. The medicinal product must— (a) have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied; and (b) be stored in a part of the aircraft which the operator is able to close so as to exclude the public.]
[F3 12. The operator of a train.	12. All medicinal products on a general sale list.	12. The medicinal product must— (a) have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied; and (b) be stored in a part of the train which the operator is able to close so as to exclude the public.]
[F4 13 Registered orthoptists [F5 against whose names are recorded in the relevant register annotations signifying that they are qualified to sell or supply the medicine specified in column 2].	13 All medicinal products on a general sale list, all pharmacy medicines and the following prescription only medicines– (a) Atropine, (b) Cyclopentolate, (c) Tropicamide, (d) Lidocaine with fluorescein, (e) Oxybuprocaine, (f) Proxymetacaine, (g) Tetracaine, (h) Chloramphenicol, (i) Fusidic acid.	13 The sale or supply shall be only in the course of their professional practice.]
[F6 14. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2.	14. All medicinal products on a general sale list, all pharmacy medicines and the following prescription only medicines which are not for parenteral administration— (a) 2.5%/2.5% Lidocaine and prilocaine periodontal gel, (b) Sodium fluoride varnish, 50mg/ml (2.26%) dental suspension (containing 22600ppm fluoride), (c) Minocycline 2% periodontal gel, (d) Sodium fluoride 0.619% (2800ppm fluoride) dental paste, (e) Sodium fluoride 1.1% (5000ppm) dental paste, (f) 15% Lidocaine, 0.15% cetrimide oromucosal spray, (g) Nystatin oral suspension.	14. The sale, supply or offer for sale or supply shall be only in the course of their professional practice.]]

Textual Amendments

F2 Words in Sch. 17 Pt. 4 substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 193(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 147(b)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Sch. 17 Pt. 4 Table Item 11, 12 inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 9

F4 Words in Sch. 17 Pt. 4 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(4) and words in Sch. 17 Pt. 4 inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(4)

F5 Words in Sch. 17 Pt. 4 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(4) and words in Sch. 17 Pt. 4 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(4)

F6 Words in Sch. 17 Pt. 4 inserted (26.6.2024) by The Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024 (S.I. 2024/729), regs. 1(2), 5(4)

Marginal Citations

M1 1970 c.40: subsection (1) was amended by section 272(1) of and Schedule 30 to the Local Government Act 1972; section 16 of and Schedule 8 paragraph 15 to the Local Government Act 1985, and section 66(6) and (8) of, and Schedule 16 paragraph 38(5) and Schedule 18 to the Local Government (Wales) Act 1994. Subsection (1A) was inserted by section 66(6) of and Schedule 16 paragraph 38(5) to that Act. Subsection 2 was substituted by section 180(1) of and Schedule 13 paragraph 85(2) to the Local Government etc (Scotland) Act 1994, and subsection (7) was repealed by sections 1(1) and 194 of, and Schedule 1 paragraph 8 and Schedule 34 Part 1 to the Local Government, Planning and Land Act 1980.