The Human Medicines Regulations 2012

Exemptions in relation to specific kinds of product U.K.

Products consisting of or containing aloxiprin, aspirin or paracetamol U.K.

236.  Regulation 214(1) does not apply to a medicinal product that is a prescription only medicine by virtue of paragraph 1(e) of Schedule 1 (non-effervescent aloxiprin, aspirin or paracetamol) if the quantity of the product sold or supplied to a person at any one time does not exceed 100 tablets or capsules.

Products consisting of or containing pseudoephedrine salts or ephedrine base or salts U.K.

237.—(1) Regulation 214(1) does not apply to a medicinal product that is a prescription only medicine by virtue of paragraph 1(f) of Schedule 1 (products consisting of or containing pseudoephedrine salts or ephedrine base or salts) if conditions A and B are met.

(2) Condition A is that the product is not sold or supplied at the same time as another medicinal product that consists of or contains—

(a) in the case of pseudoephedrine salts, ephedrine base or salts; or

(b) in the case of ephedrine base or salts, pseudoephedrine salts.

(3) Condition B is that the medicinal products sold or supplied to a person at any one time do not in total contain more than—

(a) in the case of pseudoephedrine salts, 720mg pseudoephedrine salts; or

(b) in the case of ephedrine base or salts, 180mg ephedrine base or salts.

[F1 Appropriate suppliers of naloxone products U.K.

237A.— (1) Regulations 214(1) and 220 do not apply to the supply of a naloxone product by an individual who is an appropriate supplier of naloxone products, if it is for an appropriate purpose.

(2) For the purposes of paragraph (1), the following are appropriate suppliers of naloxone products—

(a) a person employed or engaged in the provision of drug treatment services provided by or on behalf of, or under arrangements with, one of the following—

(i) an NHS body,

(ii) a local authority,

(iii) the Secretary of State, or

(iv) the Public Health Agency;

(b) a person employed or engaged in the provision of services as part of the medical services of His Majesty’s forces;

(c) a person employed or engaged by, or by an entity commissioned to provide drug treatment services by or on behalf of, one of the bodies listed below, if the listed body is satisfied that the person has undergone appropriate training in the storage and supply of naloxone products—

(i) a police force in England, Wales or Scotland,

(ii) the Police Service of Northern Ireland,

(iii) a prison service,

(iv) a provider of probation services, or

(v) a provider of youth justice services;

(d) a person who is one of the following—

(i) a pharmacist,

(ii) in England, Wales or Scotland, a registered pharmacy technician,

(iii) a registered nurse,

(iv) a registered midwife, or

(v) a registered paramedic,

if that person has undergone appropriate training in the storage and supply of naloxone products; and

(e) a person employed or engaged by a local naloxone provider, if that local naloxone provider is satisfied that the person has undergone appropriate training in the storage and supply of naloxone products.

(3) For the purposes of this regulation, a local naloxone provider is an entity that has valid arrangements in place (“local naloxone arrangements”) with a naloxone supply network co-ordinator for the supply of naloxone products for an appropriate purpose.

(4) For the purposes of this regulation, a naloxone supply network co-ordinator is an entity that has valid arrangements in place (“network creation arrangements”) with an appropriate national body as part of which the naloxone supply network co-ordinator creates and maintains a network of local naloxone providers that are willing to supply naloxone products for an appropriate purpose.

(5) For—

(a) local naloxone arrangements to be valid, a naloxone supply network co-ordinator must ensure that any putative local naloxone arrangements that it has contain arrangements that ensure; and

(b) network creation arrangements to be valid, the appropriate national body must ensure that any putative network creation arrangements that it has contain arrangements that ensure,

the outcomes listed in paragraph (6).

(6) Those outcomes are—

(a) that only persons who are employed or engaged by the putative local naloxone provider and who have undergone appropriate training in the storage and supply of naloxone products are able to supply them under the putative local naloxone arrangements;

(b) that any requirements that the appropriate national body has in respect of training in the storage and supply of naloxone products which are relevant to supply in accordance with this regulation are included in the putative local naloxone arrangements, and any such requirements are appropriate training for the purposes of paragraph (2)(e) (but see paragraph (8));

(c) that a record is kept by the putative local naloxone provider of all the persons employed or engaged by them who are able to supply naloxone products under the putative local naloxone arrangements, and of their relevant training;

(d) that the putative local naloxone provider has a named individual responsible at all times for—

(i) the storage, any handling relating to storage and any handling relating to supply of naloxone products by or on behalf of the putative local naloxone provider under their putative local naloxone arrangements, and

(ii) the maintenance of appropriate records of those activities by the putative local naloxone provider;

(e) that any requirements that the appropriate national body has in respect of storage and any handling relating to supply of naloxone products by local naloxone providers, which arise out of or relate to supply in accordance with this regulation, are included in the putative local naloxone arrangements; and

(f) that any requirements that the appropriate national body has in respect of the processing of information by local naloxone providers, including in respect of—

(i) the records to be kept as part of local naloxone arrangements,

(ii) the information to be derived from those records, and

(iii) the provision of information to naloxone supply network co-ordinators, and the occasions on which and the frequency with which to do so,

which arise out of or relate to supply in accordance with this regulation, are included in the putative local naloxone arrangements.

(7) For network creation arrangements to be valid, the appropriate national body must also ensure that any putative network creation arrangements that it has contain arrangements that ensure the following outcomes—

(a) that any requirements that the appropriate national body has in respect of the processing of information by naloxone supply network co-ordinators, including in respect of—

(i) the records to be kept as part of the network creation arrangements,

(ii) the information to be derived from those records, and

(iii) the provision of information to the appropriate national body, and the occasions on which and the frequency with which to do so,

which arise out of or relate to supply in accordance with this regulation, are included in the putative network creation arrangements; and

(b) that any requirements that the appropriate national body has in respect of who may be a local naloxone provider, and how their status as such is recorded or advertised, are included in the putative network creation arrangements.

(8) In order for training in the storage and supply of naloxone products to be appropriate for the purposes of this regulation, its outcome must be that a person completing the training successfully (T) has the following competencies—

(a) understanding of the legal framework for supply in accordance with this regulation which is sufficient for the purposes of ensuring that T is able to administer naloxone products lawfully and where appropriate to supply them to another person for that other person to administer them lawfully, having been trained to do so by T;

(b) understanding of the safe storage and safe handling of naloxone products which is sufficient for the purposes of ensuring—

(i) that T is able to store and handle naloxone products safely and without compromising their efficacy, and

(ii) if T is to supply those products to another person for that other person to store and handle them, that the other person is able to store and handle them safely, and without compromising their efficacy, having been trained to do so by T; and

(c) understanding of how and when to administer naloxone products which is sufficient for the purposes of ensuring—

(i) that T is able to do so safely, effectively and when appropriate, and

(ii) if T is to supply those products to another person for that other person to administer them, that the other person is able to administer them safely, effectively and when appropriate, having been trained to do so by T,

and if the appropriate national body for where a supply takes place has determined that that is the outcome of particular training for a particular (or any) category of person, then for where that supply takes place that determination is conclusive evidence, or in Scotland sufficient evidence, that the training is appropriate training for that category of person.

(9) The following are appropriate purposes for the purposes of this regulation—

(a) the naloxone product is needed by the person to whom or for whom it is supplied for the purpose of saving life in an emergency;

(b) in the reasonable expectation of the appropriate supplier of naloxone, the supply of the naloxone product is to enable it to be kept at a place where a person resides or which they frequent, in circumstances where that person may need, at that place—

(i) to administer it to themselves in an emergency for the purposes of saving their own life, or

(ii) to administer it to another person, or to have it administered to them, in accordance with regulation 238; or

(c) in the reasonable expectation of the appropriate supplier of naloxone, the supply of the naloxone product is to enable it to be carried about by the person to or for whom it is supplied, that person being a person who may need it—

(i) to administer it to themselves in an emergency for the purposes of saving their own life, or

(ii) to administer it to another person, or to have it administered to them, in accordance with regulation 238.

(10) Where, pursuant to this regulation, an appropriate supplier of naloxone mentioned in paragraph (2)(a) to (d) supplies a naloxone product—

(a) that appropriate supplier of naloxone;

(b) a provider of drug treatment services, medical services or other health care services that employs or engages the appropriate supplier of naloxone, if it is the entity that supplied the supplier with the naloxone product; or

(c) a body listed in paragraph (2)(a) or (c), where that body provided or commissioned the drug treatment services or other health care services as part of which the appropriate supplier of naloxone supplied the naloxone product,

may provide an appropriate national body with any information about that supply, if that type of information, or information derived from that type of information, is information that a naloxone supply network co-ordinator would be required to supply to that body under network creation arrangements, it (or the information derived from it) being information included in requirements that the appropriate national body has as mentioned in paragraph (7)(a)(iii).

(11) For the purposes of section 8(c) of the Data Protection Act 2018 (lawfulness of processing: public interest etc), provision of information in the circumstances described in paragraph (10) is to be considered necessary for the performance of a task carried out in the public interest.

(12) For the purposes of this regulation, the following are appropriate national bodies—

(a) in England, the Secretary of State;

(b) in Scotland, the Scottish Ministers;

(c) in Wales, the Welsh Ministers or Public Health Wales;

(d) in Northern Ireland, the Public Health Agency or the Department of Health in Northern Ireland.

(13) For the purposes of this regulation and regulation 238, any use of a naloxone product that is indicated in a marketing authorisation for the product is to be treated as being for the purpose of saving life, even if the use is for, or partially for, diagnosis.]

Textual Amendments

F1 Reg. 237A inserted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 7

Administration of certain medicines in an emergency U.K.

238.  Regulation 214(2) does not apply to the administration of a prescription only medicine specified in Schedule 19 where this is for the purpose of saving life in an emergency.

Administration of smallpox vaccine U.K.

239.—(1) Regulation 214(2) does not apply to the administration of smallpox vaccine if condition A or B is met.

(2) Condition A is that—

(a) the vaccine has been supplied by, on behalf of, or under arrangements made by—

(i) the Secretary of State,

(ii) the Scottish Ministers,

(iii) the Welsh Ministers,

(iv) the Department of Health, Social Services and Public Safety, or

(v) an NHS body; and

(b) the vaccine is administered for the purpose of providing protection against smallpox virus in the event of a suspected or confirmed case of smallpox in the United Kingdom.

(3) Condition B is that—

(a) the vaccine has been supplied by, on behalf of, or under arrangements made by, Her Majesty's Forces; and

(b) the vaccine is administered for the purpose of providing protection against smallpox virus to members of Her Majesty's Forces or other persons employed or engaged by them.

[F2 Radioactive medicinal products U.K.

240.— (1) Regulation 214(2) does not apply to—

(a) a radioactive substance, administration of which results in a medical exposure; or

(b) any other prescription only medicine if it is being administered in connection with a medical exposure,

if Conditions A to E are met.

(2) Condition A is that the prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to—

(a) in England and Wales and Scotland, in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations 2017 which apply to the exposure;

(b) in Northern Ireland, in regulation 6(1) and (4) of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018 which apply to the exposure.

(3) Condition B is that the medical exposure has been authorised by—

(a) an IRME practitioner; or

(b) where it is not practical for an IRME practitioner to authorise the exposure, an operator acting in accordance with written guidelines issued by an IRME practitioner.

(4) Condition C is that—

(a) in England and Wales and Scotland, the IRME practitioner mentioned in sub-paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations 2017;

(b) in Northern Ireland, the IRME practitioner mentioned in sub-paragraph (a) or (b) of paragraph (3) is the holder of a licence issued under the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.

(5) Condition D is that the prescription only medicine is not a product subject to special medical prescription.

(6) Condition E is that, in the case of a prescription only medicine that is not a radioactive substance, it is specified in the protocols referred to in paragraph (2).

(7) In this regulation—

“IRME practitioner” means—

(a)

in relation to a medical exposure in England and Wales and Scotland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2017;

(b)

in relation to a medical exposure in Northern Ireland, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;

“medical exposure” has the same meaning—

(a)

in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;

(b)

in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018;

“radioactive substance” has the same meaning—

(a)

in England and Wales and Scotland as in the Ionising Radiation (Medical Exposure) Regulations 2017;

(b)

in Northern Ireland as in the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018.]

Textual Amendments

F2 Reg. 240 substituted (6.2.2018) by The Ionising Radiation (Medical Exposure) Regulations 2017 (S.I. 2017/1322), reg. 1, Sch. 4 para. 2(3) (as substituted (6.2.2018) by S.I. 2018/121, regs. 1(2), 2(4)(b)(ii))

Exemptions in respect of certain herbal remedies U.K.

241.—(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“A”) of a herbal medicinal product if—

(a) the product does not contain a substance listed in Part 1 of Schedule 20;

(b) the product does not contain a substance listed in column 1 of Part 2 of that Schedule, unless the product is sold or supplied—

(i) in the case of a product for which there is a corresponding entry in column 2 of that Part, in or from containers or packages labelled to show a dose not exceeding the maximum dose or maximum daily dose specified in that entry, and

(ii) in the case of a product for which there is a corresponding entry in column 3 of that Part, with the percentage of the substance in the product not exceeding that specified in that entry;

(c) the sale or supply, or offer for sale or supply, takes place on premises occupied by A and from which A can exclude the public; and

(d) the product is for administration to a person (“B”) and A has been requested by or on behalf of B and in B's presence to use A's judgment as to the treatment required.

(2) A reference in this regulation to a substance listed in either Part of Schedule 20 is a reference to a substance that is obtained from any botanical source listed in either Part.

Exemption for medicinal products at high dilution U.K.

242.—(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a) the medicinal product is neither for parenteral administration nor a [F3 product subject to special medical prescription];

(b) paragraph (2) applies to the medicinal product; and

(c) P has been requested by or on behalf of a particular person and in that person's presence to use P's own judgment as to the treatment required.

(2) This paragraph applies to a medicinal product that consists solely of one or more unit preparations of—

(a) any substance where the unit preparation has been diluted to at least one part in a million (6x);

(b) any substance that is listed in Part 1 of Schedule 21 where the unit preparation has been diluted to at least one part in a thousand (3x); or

(c) any substance that—

(i) is the active substance of a medicine that is subject to general sale;

(ii) is listed in Part 3 of Schedule 21; or

(iii) in the case of a medicinal product for external use only, is listed in Part 4 of Schedule 21,

where the unit preparation has been diluted to at least one part in ten (1x).

(3) Regulation 220 does not apply to the sale, supply, or offer for sale or supply by a person of a medicinal product if—

(a) the medicinal product is neither for parenteral administration nor a [F4 product subject to special medical prescription];

(b) paragraph (4) applies to the medicinal product; and

(c) the conditions in regulation 221 are met.

(4) This paragraph applies to a medicinal product that consists solely of one or more unit preparations of—

(a) any substance where the unit preparation has been diluted to at least one part in a million million (6c);

(b) any substance that is listed in Part 2 of Schedule 21 where the unit preparation has been diluted to at least one part in a million (6x); or

(c) any substance that—

(i) is the active substance of a medicine that is subject to general sale;

(ii) is listed in Part 3 of Schedule 21; or

(iii) in the case of a medicinal product for external use only, is listed in Part 4 of Schedule 21,

where the unit preparation has been diluted to at least one part in ten (1x).

Textual Amendments

F3 Words in reg. 242(1)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(g) and words in reg. 242(1)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(g)

F4 Words in reg. 242(3)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 5(2)(g) and words in reg. 242(3)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 5(2)(g)

Exemption for certain homoeopathic medicinal products U.K.

243.—(1) Regulations 220 and 221 do not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a) a certificate of registration is in force in relation to the product;

(b) the product is not an excluded product; and

(c) P has been requested by or on behalf of a particular person and in that person's presence to use P's own judgment as to the treatment required.

(2) Regulation 220 does not apply to the sale or supply, or offer for sale or supply by a person (“P”) of a medicinal product if—

(a) a certificate of registration is in force in relation to the product;

(b) the product is not an excluded product; and

(c) the conditions in regulation 221 are met.

(3) In this regulation “excluded product” means a product that is promoted, recommended or marketed—

(a) for use as an anthelmintic;

(b) for parenteral administration;

(c) for use as eye drops;

(d) for use as an eye ointment;

(e) for use as an enema;

(f) for use wholly or mainly for irrigation of wounds or of the bladder, vagina or rectum; or

(g) for administration wholly or mainly to children being a preparation of aloxiprin or aspirin.