Part 1 Exemption from restrictions on sale and supply of 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.

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. Prescription only medicines containing any of the following substances—

(a) Diclofenac;

(b) Hydrocortisone Acetate;

(c) Miconazole;

(d) Nystatin;

(e) Phytomenadione;

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. 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. The sale or supply shall be only—

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

(b) in an emergency.

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.

9. The sale or supply shall be only—

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

(b) in an emergency.

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. 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.