
A prescription only medicine that— a is a preparation of insulin, an aerosol for the relief of asthma, an ointment or cream, and b has been made up for sale in a package elsewhere than at the place of sale or supply.,The smallest pack that the pharmacist has available for sale or supply.,
An oral contraceptive.,A quantity sufficient for a full treatment cycle.,
An antibiotic for oral administration in liquid form.,The smallest quantity that will provide a full course of treatment.,
A controlled drug within the meaning of Schedule 4 or 5 of the Misuse of Drugs Regulations 2001 or Schedule 4 or 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.,Five days' treatment.,
Any other prescription only medicine.,30 days' treatment.,

Article 1 (scope),The reference to— (a) “Article 40 of Directive 2001/83/EC ” is to be read as a reference to “regulation 17 of the Human Medicines Regulations 2012”; and (b) “Article 13 of Directive 2001/20/EC ” is to be read as a reference to “regulation 36 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.,
Article 2 (definitions),In the definition of— (a) “medicinal product”, the reference to “Article 1(2) of Directive 2001/83/EC ” is to be read as a reference to “regulation 2 of the Human Medicines Regulations 2012”; (b) “investigational medicinal product”, the reference to “Article 2(d) of Directive 2001/20/EC ” is to be read as a reference to “regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004”; (c) “manufacturer” the reference to “Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC ” is to be read as a reference to “regulation 17(1) of the Human Medicines Regulations 2012 or the authorisation referred to in regulation 36(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004”; (d) “qualified person” the reference to “Article 48 of Directive 2001/83/EC or in Article 13(2) of Directive 2001/20/EC ” is to be read as a reference to “regulation 41 of the Human Medicines Regulations 2012 or regulation 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.,
Article 3(1) (inspections),The reference to— (a) “for Article 111(1) of Directive 2001/83/EC ” is to be read as a reference to “Part 16 of the Human Medicines Regulations 2012 (enforcement)”; (b) “Article 15(1) of Directive 2001/20/EC ” is to be read as a reference to “Part 8 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (enforcement)”; (c) “the Member States”, is to be read as a reference to “the licensing authority”; (d) “Member States shall” is to be read as a reference to “The licensing authority may”; (e) “published by the Commission, of Community procedures on inspections and exchanges of information” is to be read as if after it there were inserted “or any guidance published by the licensing authority to replace that Commission guidance”.,
Article 3(2) (inspections),The reference to— (a) “competent authorities” is to be read as a reference to “licensing authority”; (b) “the second paragraph of Article 47 of Directive 2001/83/EC ” to the end is to be read as a reference to “regulation C17(1)(a) of the Human Medicines Regulations 2012, or which applies by virtue of regulation C17(2) of those Regulations”.,
Article 4(2) (conformity with good manufacturing practice),The reference to— (a) “third countries” is to be read as a reference to “country other than the United Kingdom”; (b) “Community” is to be read as a reference to “licensing authority”.,
Article 5 (compliance with marketing authorisation),The reference to— (a) “Article 9(2) of Directive 2001/20/EC ” in both places it appears is to be read as a reference to “regulation 17 of the Medicines for Human Use (Clinical Trials) Regulations 2004”; (b) “competent authorities” in both places it appears is to be read as a reference to “licensing authority”.,
Article 9 (documentation),The reference in— (a) paragraph (1) to “Article 51(3) of Directive 2001/83/EC ” is to be read as a reference to “paragraph 15(1) of Schedule 7 to the Human Medicines Regulations 2012”; (b) paragraph (2) to “competent authorities” is to be read as a reference to “licensing authority”.,
Article 11 (quality control),The reference in paragraph (2)— (a) to “point (b) of Article 20 of Directive 2001/83/EC ” is to be read as a reference to “paragraph 3 or 17 of Schedule 4 to the Human Medicines Regulations 2012”; (b) to “Article 9(2) of Directive 2001/20/EC ” is to be read as a reference to “regulation 17 of the Medicines for Human Use (Clinical Trials) Regulations 2004”; The reference in paragraph (4)— (a) to “Member State” is to be read as a reference to “United Kingdom”; (b) to “competent authority” is to be read as a reference to “licensing authority”;,
Article 12(4) (work contracted out),The reference to— (a) “competent authorities” is to be read as a reference to “licensing authority”; (b) “for Article 111 of Directive 2001/83/EC and Article 15(1) of Directive 2001/20/EC ” is to be read as a reference to “Part 16 of the Human Medicines Regulations 2012 or Part 8 of the Medicines for Human Use (Clinical Trials) Regulations 2004”.,
Article 13 (complaints, product recall and emergency unblinding),The reference to “Article 123 of Directive 2001/83/EC ” is to be read as a reference to “Part 5 of the Human Medicines Regulations 2012”.,

Paragraph (1) of the Introduction and general principles,The reference to “Articles 8 and 10(1)” is to be read as a reference to regulation 50 of the Human Medicines Regulations 2012.,
Paragraphs (1) and (2) of the Introduction and general principles,If the licensing authority has published guidelines under regulation 50(5B)(a) of the Human Medicines Regulations 2012, the reference to “the rules governing medicinal products in the European Community, Volume 2B, Notice to applicants, medicinal products for human use, presentation and content of the dossier, Common Technical Document” is to be read as a reference to that guidance.,
Paragraph (4) of the Introduction and general principles,If the licensing authority has published guidelines under regulation 50(5B)(b) of the Human Medicines Regulations 2012, the reference to “the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and the European Medicines Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of the rules governing medicinal products in the European Community” is to be read as a reference to those guidelines.,
Paragraph (6) of the Introduction and general principles,The reference to “the requirements of Commission Directive 91/356/EEC laying down the principles of and guidelines of Good Manufacturing Practice for medicinal products for human use” is to be read as a reference to the Good Manufacturing Practice Directive, as defined in regulation 8(1) of the Human Medicines Regulations 2012.,
Paragraph (6) of the Introduction and general principles,If the licensing authority has published principles and guidelines under regulation C17(1) of the Human Medicines Regulations 2012, the reference to “the principles and guidelines on GMP published by the Commission in the rules governing medicinal products in the European Community, Volume 4” is to be read as a reference to those principles and guidelines.,
Paragraph (8) of the Introduction and general principles,References to “the European Community” are to be read as references to the United Kingdom.,
Paragraph (8) of the Introduction and general principles,The references to “Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” are to be read as references to the Medicinal Products for Human Use (Clinical Trials) Regulations 2004.,
Paragraph (9) of the Introduction and general principles,The reference to “Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances and 88/320/EEC on the inspection and verification of good laboratory practice” is to be read as a reference to the Good Laboratory Practice Regulations 1999.,
Paragraph (10) of the Introduction and general principles,The reference to “Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes” is to be read as a reference to the Animals (Scientific Procedures) Act 1986.,
Paragraph (11) of the Introduction and general principles,The paragraph is to be read as follows: “In order to monitor the benefit/risk assessment, any new information not in the original application and all pharmacovigilance information shall be submitted to the licensing authority. After a marketing authorisation has been granted, any change to the data in the dossier shall be submitted to the licensing authority in accordance with the requirements of Schedule 10A to the Human Medicines Regulations 2012, as well as the requirements of Schedule 12A to those Regulations.”,
Part I, paragraph 1.2, fourth paragraph,This paragraph is to be read as follows: “Annexed to the administrative data shall be copies of the manufacturing authorisation as defined in regulation 17 of the Human Medicines Regulations 2012.”,
Part I, paragraph 1.3.1,The reference to “Article 11” is to be read as a reference to Part 2 of Schedule 8 to the Human Medicines Regulations 2012.,
Part I, paragraph 1.3.2,The reference to “Title V” is to be read as a reference to Part I3 of the Human Medicines Regulations 2012, and the references to Articles 63 and 59 are to be read as references to regulations 260 and 266 of the Human Medicines Regulations 2012.,
Part I, paragraph 1.3.4,This paragraph is to be read as omitted.,
Part I, paragraph 1.4,The reference to “Article 12.2” is to be read as a reference to paragraph 11 of Schedule 8 to the Human Medicines Regulations 2012.,
Part I, paragraph 2, first paragraph,The reference to “Article 12” is to be read as a reference to paragraph 11 of Schedule 8 to the Human Medicines Regulations 2012.,
Part I, paragraph 3.2(5), first paragraph,The reference to a “Member State” is to be read as including the United Kingdom.,
Part I, paragraph 3.2(5), second paragraph,The references to “the national pharmacopoeia of a Member State” are to be read as including references to the British Pharmacopoeia.,
Part I, paragraph 3.2(6),The reference to “the pharmacopoeia of a Member State” is to be read as including a reference to the British Pharmacopoeia.,
Part I, paragraph 3.2(12),The words “which is required by Community legislation” are to be read as omitted.,
Part I, paragraph 3.2.1.2,If the licensing authority has published guidelines under regulation 50(5B)(c) of the Human Medicines Regulations 2012, the reference to “guidelines published by the Agency” is to be read as a reference to those guidelines.,
Part I, paragraph 3.2.2.1, second paragraph,The reference to “Article 8(3)(c)” is to be read as a reference to paragraph 3 of Schedule 8 to the Human Medicines Regulations 2012.,
Part I, paragraph 3.2.2.1, second paragraph, first indent,The reference to “the national pharmacopoeia of one of the Member States” is to be read as including the British Pharmacopoeia.,
Part I, paragraph 3.2.2.1, fifth paragraph,The reference to “any Member State” is to be read as a reference to the United Kingdom and the reference to “the Member States” is to be read as a reference to the United Kingdom.,
Part I, paragraph 3.2.2.3(a),The reference to “Article 8(3)(d)” is to be read as a reference to paragraph 5 of Schedule 8 to the Human Medicines Regulations 2012.,
Part I, paragraph 4.2.2, fifth paragraph,The reference to “this Directive” is to be read as a reference to the Human Medicines Regulations 2012.,
Part I, paragraph 5.2(a),The reference to “the clinical particulars provided pursuant to Articles 8(3)(i) and 10(1)” is to be read as a reference to those particulars provided pursuant to paragraph 10 of Schedule 8 to, and regulations 51A, 52A, 53A and 54 to 56 of, the Human Medicines Regulations 2012.,
Part I, paragraph 5.2(c),The references to “the European Community” are to be read as references to the United Kingdom.,
Part I, paragraph 5.2(c), fifth paragraph,The reference to “Directive 2001/20/EC and implementing detail guidelines” is to be read as a reference to the Medicinal Products for Human Use (Clinical Trials) Regulations 2004.,
Part I, paragraph 5.2.1, second paragraph,The reference to “Article 10(1)(a)” is to be read as a reference to regulation 51A of the Human Medicines Regulations 2012.,
Part II, paragraph 1, first paragraph,The reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 54 of the Human Medicines Regulations 2012.,
Part II, paragraph 2(a),The reference to “Article 10(1)(a)(i)” is to be read as a reference to regulation 56 of the Human Medicines Regulations 2012.,
Part II, paragraph 2(b),The reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 51A of the Human Medicines Regulations 2012.,
Part II, paragraph 4, first paragraph,The first sentence is to be read as omitted and the words “in accordance with regulation 53A of the Human Medicines Regulations 2012” are to be read as added at the end of the second sentence.,
Part II, paragraph 5, first paragraph,The reference to “Article 10(1)(b)” is to be read as a reference to regulation 55 of the Human Medicines Regulations 2012.,
Part II, paragraph 6, first paragraph,The reference to “Article 22” is to be read as a reference to regulation 60 of the Human Medicines Regulations 2012.,
Part III, paragraph 1.1(a), first indent,The reference to “Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EC as regards medical devices incorporating stable derivatives of human blood or blood plasma” is to be read as a reference to the Medical Devices Regulations 2002.,
Part III, paragraph 1.1(a), third indent,The reference to “the Agency or the competent authority” is to be read as a reference to the licensing authority.,
Part III, paragraph 1.1(a), fourth indent,This indent is to be read as omitted.,
Part III, paragraph 1.1(b),The reference to “Article 109, as amended by Directive 2002/98/EC ” is to be read as a reference to the Blood Safety and Quality Regulations 2005.,
Part III, paragraph 1.1(b)(3), second paragraph,The reference to “medicinal products referred to in Article 2 of Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” is to be read as a reference to investigational medicinal products.,
Part III, paragraph 1.1.(c), second indent,This indent is to be read as follows: “The Plasma Master File is subject to a scientific and technical evaluation by the licensing authority.”,
Part III, paragraph 1.1(c), fourth indent,This indent is to be read as follows: “Changes subsequently introduced to the terms of a Plasma Master File must follow the variation procedure in Schedule 10A to the Human Medicines Regulations 2012.”,
Part III, paragraph 1.1(c), final indent,This indent is to be read as omitted.,
Part III, paragraph 1.2(c), first indent,The references to “a competent authority” and to “the Agency” are to be read as references to the licensing authority and the final two sentences are to be read as omitted.,
Part III, paragraph 1.2(c), second indent,The reference to “the Community” is to be read as a reference to the United Kingdom.,
Part III, paragraph 1.2(c), third indent,This indent is to be read as follows: “Changes in the content of a Vaccine Antigen Master File must follow the variation procedure in Schedule 10A to the Human Medicines Regulations 2012.”,
Part III, paragraph 1.2(c), fourth indent,This indent is to be read as omitted.,
Part III, paragraph 1.2(c), fifth indent,This indent is to be read as omitted.,
Part III, paragraph 2.1,The reference to “applications based on Articles 6(2) and 9” is to be read as a reference to applications in relation to radionuclide generators, radionuclide kits, radionuclide precursors and radiopharmaceuticals.,
Part III, paragraph 2.2, fourth paragraph,The reference to “Council Directives 87/18/EEC and 88/320/EEC ” is to be read as a reference to the Good Laboratory Practice Regulations 1999.,
Part III, paragraph 3, second paragraph,The reference to “Article 15” is to be read as a reference to regulation 103 of the Human Medicines Regulations 2012, the reference to “Article 14(1)” is to be read as a reference to regulation 102 of the Human Medicines Regulations 2012 and the words “referred to in Article 16(1)” are to be read as “which are not registerable homoeopathic medicinal products”.,
Part III, paragraph 3(a),The reference to “an official pharmacopoeia of a Member State” is to be read as including the British Pharmacopoeia and any pharmacopoeia used officially in a country that is included in a list published by the licensing authority for that purpose, and the reference to “the traditional names used in each Member State” is to be read as including the traditional name used in the United Kingdom.,
Part III, paragraph 3(b), final paragraph,The reference to “an official pharmacopoeia of a Member State” is to be read as including the British Pharmacopoeia.,
Part III, paragraph 3, penultimate paragraph,The reference to “Article 14(1)” is to be read as a reference to regulation 102 of the Human Medicines Regulations 2012.,
Part III, paragraph 5, first indent,The reference to “an orphan medicinal product in the meaning of Regulation (EC) No 141/2000 ” is to be read as a reference to a medicinal product to which the orphan criteria are claimed to apply.,
Part III, paragraph 5, second indent,The reference to “Article 10(1)(a)(ii)” is to be read as a reference to regulation 54 of the Human Medicines Regulations 2012 and the reference to “Article 5” is to be read as a reference to regulation 167 of the Human Medicines Regulations 2012.,
Part IV, paragraph 1, first paragraph,The reference to “point (a) of Article 2(1) of Regulation (EC) No 1394/2007 ” is to be read as a reference to regulation 2A of the Human Medicines Regulations 2012.,
Part IV, paragraph 2,This paragraph is to be read as omitted.,
Part IV, paragraph 3.1, second paragraph,The reference to “Directive 2004/23/EC ” is to be read as a reference to the Human Fertilisation and Embryology Act 1990and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the reference to “Directive 2002/98/EC ” is to be read as a reference to the Blood Safety and Quality Regulations 2005.,
Part IV, paragraph 3.3.2.1(a),The reference to “Directive 2004/23/EC ” is to be read as a reference to the Human Fertilisation and Embryology Act 1990 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007.,
Part IV, paragraph 3.4.1, heading,The reference to “devices as referred to in Article 7 of Regulation (EC) No 1394/2007 ” is to be read as a reference to medical devices, bio-materials, scaffolds or matrices.,
Part IV, paragraph 3.4.2, heading,The reference to “Article 2(1)(d) of Regulation (EC) No 1394/2007 ” is to be read as a reference to regulation 2A(10) of the Human Medicines Regulations 2012.,
Part IV, paragraph 3.4.2(c),The reference to “Commission Directive 2003/32/EC ” is to be read as a reference to the Medical Devices Regulations 2002.,
Part IV, paragraph 3.4.2(d),The reference to “Directive 93/42/EEC or Directive 90/385/EEC ” is to be read as a reference to the Medical Devices Regulations 2002.,
Part IV, paragraph 3.4.2, final paragraph,The first sentence is to be read as follows: “The applicant shall make available on request of the licensing authority any information related to the assessment by the notified body which has carried out the assessment referred to in point (d) of this section.”,

Effervescent tablets— (a) that do not contain aspirin, or (b) that do not contain more than 325 milligrams of aspirin per tablet.,30 tablets,
Effervescent tablets— (a) that contain more than 325 milligrams of aspirin per tablet, but (b) that do not contain more than 500 milligrams per tablet.,20 tablets,
Non-effervescent tablets— (a) that are enteric-coated, (b) that contain aspirin only, and (c) that do not contain more than 75 milligrams per tablet.,28 tablets,
Other non-effervescent tablets,16 tablets,
Powder or granules,10 sachets,
Capsules,16 capsules,
Liquid preparations of paracetamol intended for persons aged 12 years and over,160 millilitres,
Liquid preparations of paracetamol intended for persons aged less than 12 years,Individual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses,

Tablets,16 tablets,
Capsules,16 capsules,
Powder or granules,12 sachets,
Liquid preparations of ibuprofen,Individual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses,

Common Services Agency,The Agency,
Health authority,The health authority,
Special health authority,The special health authority,
NHS trust or NHS foundation trust,The trust,
 Local authority,The Chief Executive or Director of Public Health of the local authority,
 the United Kingdom Health Security Agency ,The Chief Executive of the United Kingdom Health Security Agency ,
 Public Health Agency,The Public Health Agency,
...,...,
A person who supplies medicinal products pursuant to an arrangement made with— a the Common Services Agency; b a health authority; c a special health authority; d an NHS trust; da an integrated care board ; db  NHS England ; dc a local authority; ... dd  the United Kingdom Health Security Agency ; de Public Health Agency; or e an NHS foundation trust; ... f . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .,The Common Services Agency (where the arrangement has been made with the Agency); otherwise the— a health authority, b special health authority, c NHS trust, ca  an integrated care board , cb  NHS England , cc a local authority, ... cd Chief Executive of the United Kingdom Health Security Agency , ce Public Health Agency, or d NHS foundation trust, ... e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . with which the arrangement has been made.,

A police force in England and Wales,The chief officer of police for that police force (within the meaning of the Police Act 1996 ),
A police force in Scotland,The chief constable of that police force (within the meaning of the Police (Scotland) Act 1967 ),
The Police Service of Northern Ireland,The Chief Constable of the Police Service of Northern Ireland,
The prison service in England and Wales,The governor of the prison in relation to which the health care in question is being provided,
The prison service in Scotland,The Scottish Prison Service Management Board,
The prison service in Northern Ireland,The Northern Ireland Prison Service Management Board,
Her Majesty's Forces,(a) the Surgeon General, (b) a Medical Director General, or (c) a chief executive of an executive agency of the Ministry of Defence,
 Contractor carrying out helicopter search and rescue operations on behalf of the Maritime and Coastguard Agency,Medical Director of the contractor carrying out search and rescue operations on behalf of the Maritime and Coastguard Agency,


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 or article 27 of the Food Safety (Northern Ireland) Order 1991 ; (b) an authorised officer within the meaning of section 5(6) of the Food Safety Act 1990 ; (c) a sampling officer within the meaning of article 38(1) of the Food (Northern Ireland) Order 1989 ; (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 , the National Health Service (Scotland) Act 1978 , the National Health Service (Wales) Act 2006 and the Health and Personal Social Services (Northern Ireland) Order 1972 , 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 UK 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.,
 12. Persons selling or supplying prescription only medicines to a school.,12. Prescription only medicines comprising: an inhaler containing salbutamol; or 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 or administering the medicinal product to pupils at the school in an emergency.,
 13 Registered orthoptists 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 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.,


1. Royal National Lifeboat Institution and certified first aiders of the Institution.,1. All prescription only medicines,1. 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 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002 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.,
. . .,. . .,. . .,
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.,
 6a. Persons operating an occupational health scheme and occupational health vaccinators employed or engaged by them.,6b. A prescription only medicine used for vaccination or immunisation ... sold or supplied to a person operating an occupational health scheme mentioned in entry 6a in response to an order in writing signed by a doctor or an occupational health vaccinator.,6c. The supply of the medicine is in the course of an occupational health scheme mentioned in entry 6a and is made, if not by a doctor, by 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.,
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.,
 11. 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.,
 12 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.,
 13. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2.,13. The following prescription only medicines— Lidocaine 2% with 1:80,000 adrenaline, Articaine hydrochloride 4% with 1:100,000 adrenaline, Articaine hydrochloride 4% with 1:200,000 adrenaline, 3% Mepivacaine hydrochloride, 3% Prilocaine with 0.54 microgram/ml felypressin, 2.5%/2.5% Lidocaine and prilocaine peridontal gel, Sodium fluoride varnish, 50mg/ml (2.26%) dental suspension (containing 22600ppm fluoride), Minocyline 2% periodontal gel, Sodium fluoride 0.619% (2800ppm fluoride) dental paste, Sodium fluoride 1.1% (5000ppm fluoride) dental paste, 15% Lidocaine, 0.15% cetrimide oromucosal spray, Nystatin oral suspension.,13. The supply shall be only in the course of their professional practice.,


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 or, regulations 8(3) or 9(3) of the Misuse of Drugs Regulations (Northern Ireland) 2002 , 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.,
 5a. Persons operating an occupational health scheme and occupational health vaccinators employed or engaged by them.,5b. A prescription only medicine used for vaccination or immunisation ... 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.,
10. Persons (“P”) who are members of Her Majesty’s armed forces.,10. All prescription only medicines.,10. The administration shall be— in the course of P undertaking any function as a member of Her Majesty’s armed forces; and 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 only in so far as is necessary— for the treatment of a sick or injured person in an emergency, or to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not administered.,
 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.,
 12. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2.,12. The following prescription only medicines for parenteral administration— 2% Lidocaine with 1:80,000 adrenaline, Articaine hydrochloride 4% with 1:100,000 adrenaline, Articaine hydrochloride 4% with 1:200,000 adrenaline, 3% Mepivacaine hydrochloride, 3% Prilocaine with 0.54 microgram/ml felypressin.,12. The administration shall be only in the course of their professional practice.,


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 , (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 UK marketing authorisation, ... , a certificate of registration or a manufacturer's licence.,9. Medicinal product referred to in the UK 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.,
11. Operator or commander of an aircraft.,11. All medicinal products on a general sale list.,11. 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; and be stored in a part of the aircraft which the operator is able to close so as to exclude the public.,
12. The operator of a train.,12. All medicinal products on a general sale list.,12. 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; and be stored in a part of the train which the operator is able to close so as to exclude the public.,
 13 Registered orthoptists 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.,
 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— 2.5%/2.5% Lidocaine and prilocaine periodontal gel, Sodium fluoride varnish, 50mg/ml (2.26%) dental suspension (containing 22600ppm fluoride), Minocycline 2% periodontal gel, Sodium fluoride 0.619% (2800ppm fluoride) dental paste, Sodium fluoride 1.1% (5000ppm) dental paste, 15% Lidocaine, 0.15% cetrimide oromucosal spray, Nystatin oral suspension.,14. The sale, supply or offer for sale or supply shall be only in the course of their professional practice.,


1. Royal National Lifeboat Institution and certificated first aiders of the Institution.,1. All medicinal products.,1. The supply shall be only so far as is necessary for the treatment of sick or injured persons.,
2. British Red Cross Society and certificated first aid and certificated nursing members of the Society.,2. All pharmacy medicines and all medicinal products on a general sale list.,2. The supply shall be only so far as is necessary for the treatment of sick or injured persons.,
3. St John Ambulance Association and Brigade and certificated first aid and certificated nursing members of the Association and Brigade.,3. All pharmacy medicines and all medicinal products on a general sale list.,3. The supply shall be only so far as is necessary for the treatment of sick or injured persons.,
4. St. Andrew's Ambulance Association and certificated first aid and certificated nursing members of the Association.,4. All pharmacy medicines and all medicinal products on a general sale list.,4. The supply shall be only so far as is necessary for the treatment of sick and injured persons.,
5. Order of Malta Ambulance Corps and certificated first aid and certificated nursing members of the Corps.,5. All pharmacy medicines and all medicinal products on a general sale list.,5. The supply shall be only so far as is necessary for the treatment of sick or injured persons.,
6. Persons authorised by licences granted under regulation 5 of the Misuse of Drugs Regulations 2001 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002.,6. Such prescription only medicines and such pharmacy medicines as are specified in the licence.,6. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.,
7. Persons employed or engaged in the provision of lawful drug treatment services.,7. Ampoules of sterile water for injection that contain no more than 5ml of water each.,7. The supply shall be only in the course of provision of lawful drug treatment services.,
. . .,. . .,. . .,
8. Persons requiring medicinal products 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.,8. Such prescription only medicines and such pharmacy medicines as may be specified in the relevant enactment and medicinal products on a general sale list.,8. The supply shall be— (a) for the purpose of enabling compliance with any requirement made by or in pursuance of any such enactment, and (b) subject to such conditions and in such circumstances as may be specified in the relevant enactment.,
9. The owner or master of a ship which does not carry a doctor on board as part of the ship's complement.,9. All medicinal products.,9. The supply shall be only so far as is necessary for the treatment of persons on the ship.,
10. Persons operating an occupational health scheme.,10. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines as are sold or supplied to a person operating an occupational health scheme in response to an order signed by a doctor or a registered nurse.,10. (a) The supply shall be in the course of an occupational health scheme. (b) The individual supplying the medicinal product, if not a doctor, shall be— (i) a registered nurse, and (ii) where the medicinal product in question is a prescription only medicine, 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 in the course of an occupational health scheme.,
 10a. Persons operating an occupational health scheme and occupational health vaccinators employed or engaged by them.,10b. A prescription only medicine used for vaccination or immunisation ... sold or supplied to a person operating an occupational health scheme mentioned in entry 10a in response to an order in writing signed by a doctor or an occupational health vaccinator.,10c. The supply of the medicine is in the course of an occupational health scheme mentioned in entry 10a, and the individual supplying 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.,
11. Persons carrying on the business of a school providing full-time education.,11. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.,11. The supply shall be— (a) in the course of a school dental scheme, and (b) if to a child under 16 only where the parent or guardian of that child has consented to such supply.,
12. Health authorities or Primary Health Trusts.,12. Pharmacy medicines that are for use in the prevention of dental caries and consist of or contain Sodium Fluoride.,12. The supply shall be in the course of— (a) a pre-school dental scheme, and the individual supplying the medicinal product shall be a registered nurse, or (b) a school dental scheme, and if to a child under 16 only where the parent or guardian of that child has consented to such supply.,
13. The operator or commander of an aircraft.,13. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of an aircraft in response to an order in writing signed by a doctor.,13. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and, in the case of a prescription only medicine, shall be in accordance with the written instructions of a doctor as to the circumstances in which the prescription only medicines of the description in question are to be used on the aircraft.,
14. Persons employed as qualified first-aid personnel on offshore installations.,14. All medicinal products.,14. The supply shall be only so far as is necessary for the treatment of persons on the installation.,
15. A prison officer.,15. All medicinal products on the general sale list.,15. The supply shall only be so far as is necessary for the treatment of prisoners.,
16. 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.,16. All pharmacy medicines, all medicinal products on a general sale list and such prescription only medicines which are sold or supplied to a person specified in column 1 of this paragraph in response to an order in writing signed by a doctor.,16. 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.,
17. Her Majesty's armed forces.,17. All medicinal products.,17. The supply shall be only so far as is necessary for the treatment of a sick or injured person or the prevention of ill-health.,
 18. A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine.,18. A prescription only medicinal product comprising an inhaler containing salbutamol.,18. 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.,
 19. Persons supplying medicinal products under an off-site emergency plan prepared under the Radiation (Emergency Preparedness and Public Information) Regulations 2019 . ,19. Pharmacy medicines which contain any of the following substances but no other active ingredient— (a) Potassium Iodide; (b) Potassium Iodate.,19. The supply shall be— (a) in accordance with the off-site emergency plan; and (b) only in the event that a radiation emergency has occurred or an event has occurred which could reasonably be expected to lead to a radiation emergency.,
 20. A person or body listed in Part 1 or 2 of Schedule 1 to the Civil Contingencies Act 2004. ,20. Pharmacy medicines which contain any of the following substances but no other active ingredient— (a) Potassium Iodide; (b) Potassium Iodate.,20. The supply shall only be in response to the occurrence, or likely occurrence, of one of the following events— (a) an emergency within the meaning of section 1 of the Civil Contingencies Act 2004; (b) a radiation emergency within the meaning of regulation 24 of the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009.,

Apocynum cannabinum,Canadian hemp,
Areca catechu,Areca,
Artemisia cina,Santonica,
Brayera anthelmintica,Kousso,
Catha edulis,Catha,
Chenopodium ambrosioides var anthelminticum,Chenopodium,
Crotalaria berberoana,Crotalaria fulva,
Crotalaria spectabilis,Crotalaria spect.,
Cucurbita maxima,Cucurbita,
Delphinium staphisagria,Stavesacre seeds,
Dryopteris filix-mas,Male fern,
Duboisia leichardtii Duboisia myoporoides,Duboisia,
Ecballium elaterium,Elaterium,
Embelia ribes Embelia robusta,Embelia,
Erysimum canescens,Erysimum,
Holarrhena antidysenterica,Holarrhena,
Juniperus sabina,Savin,
Mallotus philippinensis,Kamala,
Pausinystalia yohimbe,Yohimbe bark,
Punica granatum,Pomegranate bark,
Rhus radicans,Poison ivy,
Scopolia carniolica Scopolia japonica,Scopolia,
Strophanthus courmonti Strophanthus emini Strophanthus gratus Strophanthus hispidus Strophanthus kombe Strophanthus nicholsoni Strophanthus sarmentosus,Strophanthus,
Ulmus fulva Ulmus rubra,Slippery elm bark (whole or unpowdered),
Viscum album,Misletoe berry,

Substance,,,
Botanical Source,Common Name,Maximum dose and maximum daily dose,Percentage,
Aconitum balfourni Aconitum chasmanthum Aconitum deinorrhizum Aconitum lycoctonum Aconitum napellus Aconitum spicatum Aconitum stoerkianum Aconitum uncinatum var japonicum,Aconite,,1.3 per cent,
Adonis vernalis,Adonis vernalis,100 mg (MD) 300mg (MDD),,
Aspidosperma quebrachoblanco,Quebracho,50 mg (MD) 150 mg (MDD),,
Atropa acuminata Atropa belladonna,Belladonna herb, belladonna root,In the form of belladonna herb: 50 mg (MD) 150 mg (MDD); In the form of belladonna root: 30 mg (MD) 90 mg (MDD),,
Chelidonium majus,Celandine,2 g (MD) 6 g (MDD),,
Cinchona calisaya Cinchona ledgerana Cinchona micrantha Cinchona officinalis Cinchona succirubra,Cinchona bark,250 mg (MD) 750 mg (MDD),,
Colchicum autumnale,Colchicum corm,100 mg (MD) 300 mg (MDD),,
Conium maculatum,Conium fruits, conium leaf,,7.0 per cent,
Convallaria majalis,Convallaria,150 mg (MD) 450 mg (MDD),,
Datura innoxia Datura stramonium,Stramonium,50 mg (MD) 150 mg (MDD),,
Ephedra distachya Ephedra equisetina Ephedra gerardiana Ephedra intermedia Ephedra sinica,Ephedra,600 mg (MD) 1800 mg (MDD),,
Gelsemium sempervirens,Gelsemium,25 mg (MD) 75 mg (MDD),,
Hyoscyamus albus Hyoscyamus muticus Hyoscyamus niger,Hyoscyamus,100mg (MD) 300 mg (MDD),,
Lobelia inflata,Lobelia,200 mg (MD) 600 mg (MDD),,
Pilocarpus jaborandi Pilocarpus microphyllus,Jaborandi,,5.0 per cent,
Rhus toxicodendron,Poison oak,,10.0 per cent,
Senecio jacobaea,Ragwort,,10.0 per cent,

Medicines Act 1968 (c. 67),Sections 2A to 9. Section 10(7). Sections 11 to 14. Section 15(1) and (2). Sections 16 to 57. Section 58(1A), (2) and (3). Sections 59 to 61. Sections 65 and 66. Section 67(3A), (5) and (6). Section 68. Sections 85 and 86. Section 89. Section 91(1). Sections 92 to 103. Section 108(3) to (5) and (7). Section 109(3). Section 110(3). Section 111(3). Section 112(7). Sections 115 and 116. Section 126(4). Section 130(2) to (8) and (10). Section 132(2), (3) and (5). Schedules 1A and 2. In Schedule 3, paragraphs 5 to 7.,
Medicines (Extension to Antimicrobial Substances) Order 1973 ( S.I. 1973/367),The whole Order.,
Medicines (Specified Articles and Substances) Order 1976 ( S.I. 1976/968),The whole Order.,
Medicines (Fluted Bottles) Regulations 1978 ( S.I. 1978/40),The whole of the Regulations.,
Medicines (Medicines Act 1968 Amendment) Regulations 1983 ( S.I. 1983/1724),The whole of the Regulations.,
Medicines (Products Other than Veterinary Drugs) (General Sale List) Amendment Order 1990 ( S.I. 1990/1129),The whole Order.,
Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992 ( S.I. 1992/605),The whole of the Regulations.,
Medicines Act 1968 (Amendment) Regulations 1993 ( S.I. 1993/834),The whole of the Regulations.,
Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 ( S.I. 1994/105),The whole of the Regulations.,
Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1994 ( S.I. 1994/899),The whole of the Regulations.,
Medicines (Advertising) Regulations 1994 ( S.I. 1994/1932),The whole of the Regulations.,
Medicines (Monitoring of Advertising) Regulations 1994 ( S.I. 1994/1933),The whole of the Regulations.,
Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 ( S.I. 1994/3144),The whole of the Regulations.,
Medicines Act 1968 (Amendment) Regulations 1995 ( S.I. 1995/2321),The whole of the Regulations.,
Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996 ( S.I. 1996/482),The whole of the Regulations.,
Prescription Only Medicines (Human Use) Order 1997 ( S.I. 1997/1830),The whole of the Order except articles 1(1) to (5), 5 and 10 and Schedules 1 and 2.,
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 1998 ( S.I. 1998/3105),The whole of the Regulations.,
Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 ( S.I. 1999/267),The whole of the Regulations.,
Medicines (Monitoring of Advertising) Amendment Regulations 1999 ( S.I. 1999/784),The whole of the Regulations.,
Medicines (Codification Amendments Etc.) Regulations 2002 ( S.I. 2002/236),The whole of the Regulations,
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2003 ( S.I. 2003/1618),The whole of the Regulations.,
Medicines (Child Safety) Regulations 2003 ( S.I. 2003/2317),The whole of the Regulations.,
Medicines (Advertising) Amendment Regulations 2004 ( S.I. 2004/1480),The whole of the Regulations.,
Medicines for Human Use (Prescribing) Order 2005 ( S.I. 2005/765),The whole Order.,
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2005 ( S.I. 2005/768),The whole of the Regulations.,
Medicines (Advisory Bodies) Regulations 2005 ( S.I. 2005/1094),The whole of the Regulations except paragraph 12(1), (4) and (5) of Schedule 1, and regulation 8 as it relates to those paragraphs.,
Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2005 ( S.I. 2005/1520),The whole of the Regulations.,
Medicines (Provision of False or Misleading Information and Miscellaneous Amendments) Regulations 2005 ( S.I. 2005/1710),The whole of the Regulations.,
Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 ( S.I. 2005/2750),The whole of the Regulations except paragraph 8(a)(i) and (b) of Schedule 7, and regulation 12 as it relates to those paragraphs.,
Medicines (Advisory Bodies) (No 2) Regulations 2005 ( S.I. 2005/2754),The whole of the Regulations, except Schedule 3, and regulation 4 as it relates to that Schedule, and paragraphs 3 and 7(1) and (3) of Schedule 4, and regulation 5 as it relates to those paragraphs.,
Medicines (Advertising Amendments) Regulations 2005 ( S.I. 2005/2787),The whole of the Regulations.,
Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 ( S.I. 2005/2789),The whole of the Regulations.,
Medicines (Traditional Herbal Medicinal Products for Human Use) (Consequential Amendment) Regulations 2006 ( S.I. 2006/395),The whole of the Regulations.,
Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006 ( S.I. 2006/1952),The whole of the Regulations.,
Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008 ( S.I. 2008/1692),The whole of the Regulations.,
Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 ( S.I. 2008/3097),The whole of the Regulations.,
Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 ( S.I. 2009/1164),The whole of the Regulations, except regulation 3.,
Medicines (Exemptions and Miscellaneous Amendments) Order 2009 ( S.I. 2009/3062),The whole Order.,
Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 ( S.I. 2010/1882),The whole of the Regulations.,
