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The Human Medicines Regulations 2012

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PART 1U.K.Exemption from restrictions on sale and supply of prescription only medicines

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.1. All prescription only medicines.

1. The sale or supply shall be—

(a) subject to the presentation of an order signed by the principal of an institution concerned with educational research or the appropriate head of department in charge of a specified course of research stating—

(i) the name of the institution for which the prescription only medicine is required, and

(ii) the purpose for which the prescription only medicine is required, and

(iii) the total quantity required; and

(b) for the purpose of the education or research with which the institution is concerned.

2. Persons selling or supplying prescription only medicines to any of the following—

(a) a public analyst appointed under section 27 of the Food Safety Act 1990 M1 or article 27 of the Food Safety (Northern Ireland) Order 1991 M2;

(b) an authorised officer within the meaning of section 5(6) of the Food Safety Act 1990 M3;

(c) a sampling officer within the meaning of article 38(1) of the Food (Northern Ireland) Order 1989 M4;

(d) an inspector acting under regulations 325 to 328;

(e) a sampling officer within the meaning of Schedule 31.

2. All prescription only medicines.2. The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1 stating the status of the person signing it and the amount of prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.
3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 2006 M5, the National Health Service (Scotland) Act 1978 M6, the National Health Service (Wales) Act 2006 M7 and the Health and Personal Social Services (Northern Ireland) Order 1972 M8, or under any subordinate legislation made under those Acts or that Order.3. All prescription only medicines

3. The sale or supply shall be—

(a) subject to the presentation of an order signed by or on behalf of the person so employed or engaged stating the status of the person signing it and the amount of the prescription only medicine required; and

(b) for the purposes of a scheme referred to in column 1 in this paragraph.

4. Registered midwives.

4. Prescription only medicines containing any of the following substances—

(a) Diclofenac;

(b) Hydrocortisone Acetate;

(c) Miconazole;

(d) Nystatin;

(e) Phytomenadione;

4. The sale or supply shall be only in the course of their professional practice.
5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.5. Water for injection.

5. The sale or supply is to a person—

(a) for a purpose other than parenteral administration; or

(b) who has been prescribed dry powder for parenteral administration but has not been prescribed the water for injection that is needed as a diluent.

6. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

6. Items which are—

(a) prescription only medicines which are not for parenteral administration and which—

(i) are eye drops and are prescription only medicines by reason only that they contain not more than 0.5 per cent of Chloramphenicol, or

(ii) are eye ointments and are prescription only medicines by reason only that they contain not more than 1.0 per cent Chloramphenicol, or

(iii) are prescription only medicines by reason only that they contain any of the following substances—

(aa) Cyclopentolate hydrochloride,

(bb) Fusidic Acid,

(cc) Tropicamide;

(b) 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 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 hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.

6. The sale or supply shall be subject to the presentation of an order signed by—

(a) a registered optometrist for a medicine listed under item (a) in column 2;

(b) a registered chiropodist or podiatrist for a medicine listed under item (b) in column 2.

7. Registered optometrists.7. Prescription only medicines listed in item (a) of paragraph 6 column 2.

7. The sale or supply shall be only—

(a) in the course of their professional practice, and

(b) in an emergency.

8. Persons lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968.

8. Medicinal products not for parenteral administration 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) Lodoxamide,

(j) Nedocromil sodium,

(k) Olopatadine,

(l) Pilocarpine hydrochloride,

(m) Pilocarpine nitrate,

(n) Polymyxin B/bacitracin,

(o) Polymyxin B/trimethoprim,

(p) Sodium cromoglycate.

8. The sale or supply shall be subject to the presentation of an order signed by an additional supply optometrist.
9. Additional supply optometrists.9. Prescription only medicines specified in paragraph 8 column 2.

9. The sale or supply shall be only—

(a) in the course of their professional practice, and

(b) in an emergency.

10. Holders of [F1UK marketing authorisations, EU marketing authorisations], product licences or manufacturer's licences.10. Prescription only medicines referred to in those authorisations or licences.

10. 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 prescription only medicine 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.

11. Registered chiropodists or podiatrists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicine specified in column 2.

11. The following prescription only medicines—

(a) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight,

(b) Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in lacquer does not exceed 5 per cent by weight in volume,

(c) Amoxicillin,

(d) Co-Codamol,

(e) Co-dydramol 10/500 tablets,

(f) Codeine Phosphate,

(g) Erythromycin,

(h) Flucloxacillin,

(i) Silver Sulfadiazine,

(j) Tioconazole 28%,

(k) Topical hydrocortisone where the maximum strength of hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.

11. The sale or supply shall be only in the course of their professional practice.
[F212. Persons selling or supplying prescription only medicines to a school. 12.

[F3Prescription only medicines comprising:

(a)

an inhaler containing salbutamol; or

(b)

an auto-injector containing adrenaline]

12. The sale or supply shall be—

(a) subject to the presentation of an order signed by the principal or head teacher at the school concerned stating—

(i) the name of the school for which the medicinal product is required,

(ii) the purpose for which that product is required, and

(iii) the total quantity required, and

(b) for the purpose of supplying [F4or administering] the medicinal product to pupils at the school in an emergency.]

[F513 Registered orthoptists [F6against 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 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.]

Textual Amendments

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

F3Words in Sch. 17 Pt. 1 substituted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(a)(i) and words in Sch. 17 Pt. 1 substituted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(a)(i)

F4Words in Sch. 17 Pt. 1 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(a)(ii) and words in Sch. 17 Pt. 1 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(a)(ii)

F5Words in Sch. 17 Pt. 1 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(2) and words in Sch. 17 Pt. 1 inserted (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(2)

F6Words in Sch. 17 Pt. 1 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(2)(b) and words in Sch. 17 Pt. 1 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(2)(b)

Marginal Citations

M11990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.

M21991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.

M41989 No. 846 (N.I. 6).

Yn ôl i’r brig

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