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The Human Medicines Regulations 2012

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Regulations 223(5)(b) and (c) 235,250(5) and 253(5)(d)

SCHEDULE 17U.K.Exemption for sale, supply or administration by certain persons

This schedule has no associated Explanatory Memorandum

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).

PART 2U.K.Exemption from the restriction on supply of prescription only medicines

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Royal National Lifeboat Institution and certified first aiders of the Institution.1. All prescription only medicines1. 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 M9 or regulation 5 of the Misuse of Drugs Regulations (Northern Ireland) 2002 M10 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.

[F74a Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies–

(a) an NHS body;

(b) a local authority;

(c) Public Health England; or

(d) Public Health Agency.

4a A prescription only medicine F8... containing naloxone hydrochloride but no other substance that is classified as a product available on prescription only.4a The supply shall be only in the course of provisions of lawful drug treatment services and only where required for the purpose of saving life in an emergency.]
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.

[F96a. An NHS body or a local authority operating an occupational health scheme and occupational health vaccinators employed or engaged by them. 6b. A prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (of any type) sold or supplied to a person operating an occupational health scheme mentioned in entry 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.

[F1011. 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.]

[F1112 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.]

Textual Amendments

F7Words 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)

F8Words in Sch. 17 Pt. 2 omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 18(a) and words in Sch. 17 Pt. 2 omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 18(a)

F10Words in Sch. 17 Pt. 2 added (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 27(3) and words in Sch. 17 Pt. 2 added (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 27(3)

F11Words in Sch. 17 Pt. 2 inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 16(3) and words in Sch. 17 Pt. 2 inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 16(3)

Marginal Citations

M9S.I. 2001/3998, to which there are amendments that are not relevant.

M10S.R. 2002 No. 1, to which there are amendments that are not relevant.

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

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
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 M11 or, regulations 8(3) or 9(3) of the Misuse of Drugs Regulations (Northern Ireland) 2002 M12, 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.

[F125a. An NHS body or a local authority operating an occupational health scheme and occupational health vaccinators employed or engaged by them. 5b. A prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (of any type) sold or supplied to a person operating an occupational health scheme mentioned in entry 5a in response to an order in writing signed by a doctor or an occupational health vaccinator.5c. The administration of the medicine is in the course of an occupational health scheme mentioned in entry 5a, and the individual administering the medicine is, if not a doctor, an occupational health vaccinator acting in accordance with the written directions of a doctor as to the circumstances in which such medicines are to be used.]
6. The operator or commander of an aircraft.6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of the doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons employed as qualified first-aid personnel on off-shore installations.7. All prescription only medicines that are for parenteral administration.7. The administration shall be only so far as is necessary for the treatment of persons on the installation.
8. Persons who are registered paramedics.

8. The following prescription only medicines for parenteral administration—

(a) Diazepam 5 mg per ml emulsion for injection,

(b) Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion,

(c) medicines containing the substance Ergometrine Maleate 500 mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient,

(d) prescription only medicines containing one or more of the following substances, but no other active ingredient—

(i) Adrenaline Acid Tartrate,

(ii) Adrenaline hydrochloride,

(iii) Amiodarone,

(iv) Anhydrous glucose,

(v) Benzlypenicillin,

(vi) Compound Sodium Lactate Intravenous Infusion (Hartmann's Solution),

(vii) Ergometrine Maleate,

(viii) Furosemide,

(ix) Glucose,

(x) Heparin Sodium,

(xi) Lidocaine Hydrochloride,

(xii) Metoclopramide,

(xiii) Morphine Sulphate,

(xiv) Nalbuphine Hydrochloride,

(xv) Naloxone Hydrochloride,

(xvi) Ondansetron

(xvii) Paracetamol,

(xviii) Reteplase,

(xix) Sodium Chloride,

(xx) Streptokinase,

(xxi) Tenecteplase.

8. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.
9. Persons who hold the advanced life support provider certificate issued by the Resuscitation Council (UK).

9. The following prescription only medicines for parenteral administration —

(a) Adrenaline 1:10,000 up to I mg; and

(b) Amiodarone.

9. The administration shall be only in an emergency involving cardiac arrest, and in the case of adrenaline the administration shall be intravenous only.
[F1310. Persons (“P”) who are members of Her Majesty’s armed forces.10. All prescription only medicines.

10. The administration shall be—

(a)

in the course of P undertaking any function as a member of Her Majesty’s armed forces; and

(b)

where P is satisfied that it is not practicable for another person who is legally entitled to administer a prescription only medicine to do so; and

(c)

only in so far as is necessary—

(i)

for the treatment of a sick or injured person in an emergency, or

(ii)

to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not administered.]

[F1411 A person (“P”) carrying on the business of a school who is trained to administer the relevant medicine. 11 A prescription only medicine comprising an auto-injector containing adrenaline.

11 The administration shall be—

(a) in the course of P carrying on the business of a school;

(b) where administration is to a pupil at that school who is known to be at risk of anaphylaxis; and

(c) where the pupil requires the medicinal product in an emergency.]

Textual Amendments

F13Words in Sch. 17 Pt. 3 added (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 11 and words in Sch. 17 Pt. 3 added (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 11

F14Words in Sch. 17 Pt. 3 inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 8(3) and words in Sch. 17 Pt. 3 inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 8(3)

Marginal Citations

M11S.I. 2001/3998 as amended by S.I. 2007/2154. There are other amendments that are not relevant.

M12S.R. 2002 No. 1, as amended by S.R. 2007 No. 348. There are other amendments that are not relevant.

PART 4U.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

Column 1Column 2Column 3
Persons exemptedMedicinal products to which exemption appliesConditions
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 M13,

(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 [F15UK marketing authorisation, EU marketing authorisation], a certificate of registration or a manufacturer's licence.9. Medicinal product referred to in the [F15UK 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.
[F1611. 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.]

[F1612. 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.]

[F1713 Registered orthoptists [F18against 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.]

Textual Amendments

F16Sch. 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

F17Words 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)

F18Words 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)

Marginal Citations

M131970 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.

PART 5U.K.Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products

Column 1Column 2Column 3
Persons exemptedMedicinal products to which exemption appliesConditions
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.

[F197a Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies–

(a) an NHS body;

(d) a local authority;

(c) Public Health England; or

(d) Public Health Agency.

7a [F20A medicinal product containing naloxone hydrochloride but no other substance that is classified as a product available only on prescription or as a product available only from a pharmacy.]7a The supply shall be only in the course of provisions of lawful drug treatment services and only where required for the purpose of saving life in an emergency.]
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.

[F2110a. An NHS body or a local authority operating an occupational health scheme and occupational health vaccinators employed or engaged by them. 10b. A prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (of any type) sold or supplied to a person operating an occupational health scheme mentioned in entry 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.
[F2218. 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.]

[F2319. Persons supplying medicinal products under an off-site emergency plan prepared under the [F24Radiation (Emergency Preparedness and Public Information) Regulations 2019].]

[F2319. Pharmacy medicines which contain any of the following substances but no other active ingredient—

(a) Potassium Iodide;

(b) Potassium Iodate.]

[F2319. 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.]

[F2320. A person or body listed in Part 1 or 2 of Schedule 1 to the Civil Contingencies Act 2004.]

[F2320. Pharmacy medicines which contain any of the following substances but no other active ingredient—

(a) Potassium Iodide;

(b) Potassium Iodate.]

[F2320. 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 [F25radiation] emergency within the meaning of regulation 24 of the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009.]

Textual Amendments

F19Words in Sch. 17 Pt. 5 added (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 10(3) and words in Sch. 17 Pt. 5 added (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 10(3)

F20Words in Sch. 17 Pt. 5 substituted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 18(b) and words in Sch. 17 Pt. 5 substituted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 18(b)

F22Words in Sch. 17 Pt. 5 added (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 27(4) and words in Sch. 17 Pt. 5 added (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 27(4)

F23 Words in Sch. 17 Pt. 5 inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 12(2) and words in Sch. 17 Pt. 5 inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 12(2)

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