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The Human Medicines Regulations 2012

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CHAPTER 2U.K.Requirements relating to advertising

GeneralU.K.

Products without a marketing authorisation etcU.K.

[F1279.—(1) A person may not publish an advertisement in Great Britain for a medicinal product unless one of the following is in force for the product—

(a)a UKMA(GB) or UKMA(UK);

[F2(aa)an authorisation by the licensing authority on a temporary basis under regulation 174;]

(b)a COR(GB) or COR(UK); or

(c)a THR(GB) or THR(UK).

(2) A person may not publish an advertisement in Northern Ireland for a medicinal product unless one of the following is in force for the product—

(a)a UKMA(NI) or UKMA(UK);

[F3(aa)an authorisation by the licensing authority on a temporary basis under regulation 174;]

(b)a COR(NI) or COR(UK);

(c)a THR(NI) or THR(UK);

(d)an EU marketing authorisation; or

(e)an Article 126a authorisation.

(3) A person may not publish an advertisement in the whole United Kingdom for a medicinal product unless, in relation to that product—

(a)one of the authorisations or registrations specified in paragraph (1) is in force in Great Britain; and

(b)one of the authorisations or registrations specified in paragraph (2) is in force in Northern Ireland.]

Textual Amendments

F2Reg. 279(1)(aa) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 11(a) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350, regs. 1(3), 11(a)

General principlesU.K.

280.—(1) A person may not publish an advertisement for a medicinal product with a [F4UK marketing authorisation, EU marketing authorisation,] traditional herbal registration or Article 126a authorisation unless the advertisement complies with the particulars listed in the summary of the product characteristics.

[F5(1A) Where an advertisement mentioned in paragraph (1) relates to a product in relation to which there is a separate authorisation or registration in force in Great Britain and in Northern Ireland, it may not be published in the whole United Kingdom unless it complies with the particulars listed in the summary of the product characteristics in each of those authorisations or registrations (as the case may be).]

(2) A person may not publish an advertisement for a medicinal product unless the advertisement encourages the rational use of the product by presenting it objectively and without exaggerating its properties.

(3) A person may not publish an advertisement for a medicinal product that is misleading.

[F6(4) A person may not publish an advertisement for a medicinal product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174 (but not an authorisation, certificate or registration as mentioned in regulation [F7281(1)(a) to (e)]), unless it is published as part of a campaign that has been approved by the Ministers.]

Textual Amendments

Duties of authorisation holders and registration holdersU.K.

281.—(1) This regulation applies to a person who holds—

(a)a [F8UK] marketing authorisation for a medicinal product;

(b)a certificate of registration for a medicinal product;

(c)a traditional herbal registration for a medicinal product; F9...

(d)an Article 126a authorisation for a medicinal product [F10; or

(e)an EU marketing authorisation for a medicinal product.]

[F11(1A) Paragraphs (3) to (5) apply to the holder of a temporary authorisation in relation to a medicinal product.]

(2) The person must establish a scientific service to compile and collate all information relating to the product (whether received from medical sales representatives employed by that person or from any other source).

(3) The person must ensure that any medical sales representative who promotes the product is given sufficient training, and has sufficient scientific knowledge, to enable the representative to provide information about the product that is as precise and complete as possible.

(4) The person must retain—

(a)a sample of any advertisement for which the person is responsible relating to the product; and

(b)a statement indicating the persons to whom the advertisement is addressed, the method of its publication and the date when it was first published.

(5) The person must, if required to do so by notice given to the person by the Ministers, within the period specified in that notice—

(a)provide a copy of the sample and statement mentioned in paragraph (4) to the Ministers;

(b)supply such other information as the Ministers may request for the purposes of their functions under this Part; or

(c)provide such assistance as the Ministers may request for those purposes.

Textual Amendments

Advertising to the publicU.K.

Application of regulations 283 to 292U.K.

282.  Regulations 283 (products for the purpose of inducing abortions) to 292 (exception for approved vaccination campaigns) apply to advertisements wholly or mainly directed at members of the public

Products for the purpose of inducing abortionsU.K.

283.  A person may not publish an advertisement that is likely to lead to the use of a medicinal product for the purpose of inducing an abortion.

Prescription only medicinesU.K.

284.—(1) A person may not publish an advertisement that is likely to lead to the use of a prescription only medicine.

(2) This regulation is subject to [F12regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

Textual Amendments

[F13Medicines with differing classification status in Great Britain and Northern IrelandU.K.

284A.  In the case of a medicinal product for sale or supply in Great Britain where the product concerned is not a prescription only medicine in Great Britain but is either—

(a)a prescription only medicine in Northern Ireland; or

(b)not authorised for sale or supply in Northern Ireland,

any advertisement to the public must include a statement that the medicinal product is not available without a prescription, or is not available for sale or supply, in Northern Ireland (as the case may be).]

Textual Amendments

Narcotic and psychotropic substancesU.K.

285.—(1) A person may not publish an advertisement relating to a medicinal product that—

(a)contains a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or

(b)contains a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).

(2) This regulation is subject to [F14regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

Textual Amendments

Material relating to diagnosisU.K.

286.—(1) A person may not publish an advertisement relating to a medicinal product that states, or implies, that a medical consultation or surgical operation is unnecessary.

(2) A person may not, in particular, publish an advertisement relating to a medicinal product that offers to provide a diagnosis or suggest a treatment by post or by means of an electronic communications network within the meaning of the Communications Act 2003.

(3) A person may not publish an advertisement relating to a medicinal product that might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis.

Material about effects of medicinal productU.K.

287.—(1) A person may not publish an advertisement relating to a medicinal product that suggests that the effects of taking the medicinal product—

(a)are guaranteed;

(b)are better than or equivalent to those of another identifiable treatment or medicinal product; or

(c)are not accompanied by any adverse reaction.

(2) A person may not publish an advertisement relating to a medicinal product that uses in terms that are misleading or likely to cause alarm pictorial representations of—

(a)changes in the human body caused by disease or injury; or

(b)the action of the medicinal product on the human body.

(3) A person may not publish an advertisement relating to a medicinal product that refers in terms that are misleading or likely to cause alarm to claims of recovery.

(4) A person may not publish an advertisement relating to a medicinal product that suggests that—

(a)the health of a person who is not suffering from any disease or injury could be enhanced by taking the medicinal product; or

(b)the health of a person could be affected by not taking the medicinal product.

(5) Paragraph (4)(b) is subject to [F15regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

Textual Amendments

Material about status of medicinal productU.K.

288.  A person may not publish an advertisement relating to a medicinal product that suggests that—

(a)it is a foodstuff, cosmetic or other consumer product that is not a medicinal product; or

(b)its safety or efficacy is due to the fact that it is natural.

Recommendations by scientists etcU.K.

289.  A person may not publish an advertisement relating to a medicinal product that refers to a recommendation by—

(a)scientists;

(b)health care professionals; or

(c)persons who because of their celebrity could encourage use of the medicinal product.

Advertisements directed at childrenU.K.

290.  A person may not publish an advertisement relating to a medicinal product that contains any material that is directed principally at children.

Form and content of advertisementU.K.

291.—(1) A person may not publish an advertisement relating to a medicinal product unless it is presented so that—

(a)it is clear that it is an advertisement; and

(b)the product is clearly identified as a medicinal product.

(2) A person may not publish an advertisement relating to a medicinal product unless it includes—

(a)the name of the medicinal product;

(b)if the medicinal product contains only one active ingredient, the common name of the active ingredient;

(c)the information necessary for the correct use of the medicinal product; and

(d)an express and clear invitation to read carefully the instructions on the package or in the package leaflet (as the case may be).

(3) This regulation is subject to regulation 296 (exception for advertisements intended as a reminder).

(4) Paragraph (2) is subject to regulation 301 (advertisements for registered homoeopathic medicinal products).

[F16(5) Paragraph (2)(d) is subject to regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.).]

Textual Amendments

[F17Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.U.K.

291A.—(1) Regulations 284 (prescription only medicines), 285 (narcotic and psychotropic substances), 287(4)(b) (material about effects of a medicinal product) and 291(2)(d) (form and content of advertisement) do not apply to an advertisement as part of a campaign that—

(a)relates to the use of a medicinal product in response to the suspected or confirmed spread of—

(i)pathogenic agents,

(ii)toxins,

(iii)chemical agents, or

(iv)nuclear radiation; and

(b)has been approved by the Ministers.

(2) Before approving a campaign that relates to—

(a)all or any area of Scotland, the Ministers must consult the Scottish Ministers;

(b)all or any areas of Wales, the Ministers must consult the Welsh Ministers.]

Textual Amendments

Exception for approved vaccination campaignsU.K.

292.  Regulations 284 (prescription only medicines), 285 (narcotic and psychotropic substances) and 287(4)(b) (material about effects of medicinal products) do not apply to an advertisement as part of a vaccination campaign that—

(a)relates to a medicinal product that is a vaccine or serum; and

(b)has been approved by the Ministers.

Prohibition of supply to the public for promotional purposesU.K.

Prohibition of supply to the public for promotional purposesU.K.

293.—[F18(1) The holder of [F19either a temporary authorisation or]—

(a)in the case of a medicinal product for sale or supply in Great Britain, a UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK); or

(b)in the case of a medicinal product for sale or supply in Northern Ireland, a UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation or Article 126a authorisation,

may not sell or supply a medicinal product for a promotional purpose to a person who is not qualified to prescribe medicinal products.]

(2) A person who carries on a medicines business may not sell or supply a medicinal product for a promotional purpose to a person who is not qualified to prescribe medicinal products.

(3) This regulation applies regardless of whether the promotional purpose is that of the seller or supplier or of a third party.

(4) In this regulation “medicines business” means a business that consists in whole or in part of manufacturing, selling or supplying medicinal products.

Textual Amendments

Advertising to persons qualified to prescribe or supply etcU.K.

General requirementsU.K.

294.—(1) This regulation applies to an advertisement that—

(a)relates to a medicinal product; and

(b)is wholly or mainly directed at persons qualified to prescribe or supply such products.

(2) A person may not publish an advertisement to which this regulation applies unless—

(a)subject to [F20paragraphs (2C) and (3),] it contains the particulars set out in paragraphs 1 to 8 of Schedule 30; and

(b)in the case of a written advertisement, it is in accordance with paragraph 9 of that Schedule.

[F21(2A) By way of an exception to paragraph (2), in the case of an advertisement that relates to a pharmacy medicine or a medicinal product subject to general sale, a person may publish the advertisement if it contains—

(a)the particulars set out in paragraphs 2 to 6 of Schedule 30; and

(b)the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:”; accompanied by

(c)a website address that corresponds to that statement.

(2B) The website at the address mentioned in paragraph (2A)(c) must make available—

(a)the particulars set out in paragraphs 1 to 8 of Schedule 30; or

(b)a copy of the summary of the product characteristics.]

[F22(2C) Paragraph 1 of Schedule 30 does not apply in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174.]

(3) In the case of an advertisement that is not a written advertisement, those particulars may alternatively be made available in written form to all persons to whom the advertisement is made available.

(4) This regulation—

(a)does not apply to an advertisement to which regulation 295 (abbreviated advertisements) applies;

(b)does not apply to oral representations made by medical sales representatives to which regulation 299 (medical sales representatives) applies; and

(c)is subject to regulations 296 (exception for advertisements intended as a reminder) and 301 (advertisements for registered homoeopathic medicinal products).

[F23(5) In the case of an advertisement which relates to a medicinal product for sale or supply—

(a)in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,

(b)in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and

(c)in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—

(i)the product for sale or supply in Great Britain, and

(ii)the product for sale or supply in Northern Ireland.]

Textual Amendments

Abbreviated advertisementsU.K.

295.—(1) This regulation applies to an abbreviated advertisement that—

(a)relates to a medicinal product; and

(b)is wholly or mainly directed at persons qualified to prescribe or supply such products.

(2) A person may not issue an abbreviated advertisement to which this regulation applies unless it contains—

(a)the particulars set out in paragraphs 2 to 6 of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply);

(b)the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:”; accompanied by

(c)a web site address that corresponds to that statement; and

[F24(d)the name and address of the holder [F25of either the temporary authorisation or]—

(i)in the case of a medicinal product for sale or supply in Great Britain, of the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK) for the medicinal product, or

(ii)in the case of a medicinal product for sale or supply in Northern Ireland, the name and address of the holder of the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation, or Article 126a authorisation for the medicinal product,

or the business name and address of the part of the holder's business that is responsible for the sale or supply of the medicinal product.]

(3) The web site at the address mentioned in sub-paragraph (2)(c) must make available—

(a)the particulars set out in Schedule 30; or

(b)a copy of the summary of the product characteristics.

(4) In this regulation, “abbreviated advertisement” means an advertisement, other than a loose insert, that—

(a)does not exceed 420 square centimetres in size; and

(b)appears in a publication sent or delivered wholly or mainly to persons qualified to prescribe or supply medicinal products.

[F26(4A) In the application of this regulation to a medicinal product for sale or supply—

(a)in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,

(b)in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and

(c)in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—

(i)the product for sale or supply in Great Britain, and

(ii)the product for sale or supply in Northern Ireland.]

(5) This regulation is subject to regulation 301 (advertisements for registered homoeopathic medicinal products).

Textual Amendments

Exception for advertisements intended as a reminderU.K.

296.  Regulations 291 (form and content of advertisement) and 294 (general requirements) do not apply to an advertisement relating to a medicinal product if the advertisement is intended solely as a reminder of the product and consists solely of—

(a)in the case of a product other than a homoeopathic medicinal product to which a certificate of registration relates, its name, international non-proprietary name or trademark; and

(b)in the case of a homoeopathic medicinal product to which a certificate of registration relates, its name, international non-proprietary name, invented name or trademark or the scientific name of the stock or stocks from which it is derived.

Written material accompanying promotionsU.K.

297.—(1) A person may not as part of the promotion of a medicinal product send or deliver any written material to a person qualified to prescribe or supply medicinal products unless the material—

(a)[F27subject to paragraph (1A),] contains particulars in accordance with all the paragraphs of Schedule 30; and

(b)states the date on which it was drawn up or last revised.

[F28(1A) Paragraph 1 of Schedule 30 does not apply in the case of a product in relation to which there is in force an authorisation by the licensing authority on a temporary basis under regulation 174.]

(2) A person may not include any information in written material to which paragraph (1) applies unless it—

(a)is accurate;

(b)is up-to-date;

(c)can be verified; and

(d)is sufficiently complete to enable the recipient to form an opinion of the therapeutic value of the product to which it relates.

(3) A person may not include any illustrative material in written material to which paragraph (1) applies unless—

(a)the illustrative material is accurately reproduced; and

(b)the written material indicates the precise source of the illustrative material.

(4) In this regulation “illustrative material” means a quotation, table or any other illustrative material taken from a medical journal or other scientific work.

Textual Amendments

Free samples for persons qualified to prescribe or supply medicinal productsU.K.

298.—(1) A person (“the supplier”) may not supply a free sample of a medicinal product to another person (“the recipient”) unless the following conditions are met.

(2) Condition A is that the recipient—

(a)is qualified to prescribe medicinal products; and

(b)receives the sample for the purpose of acquiring experience in dealing with the product in question.

(3) Condition B is that the sample is supplied to the recipient—

(a)on an exceptional basis; and

(b)in response to a request from, and signed and dated by, the recipient.

(4) Condition C is that, taking the year in which the sample is supplied as a whole, only a limited number of samples of the product in question are supplied to the recipient in that year.

(5) Condition D is that the sample—

[F29(a)is no larger than the smallest presentation of the product that is available for sale—

(i)in the case of a medicinal product for sale or supply in Great Britain, in Great Britain, or

(ii)in the case of a medicinal product for sale or supply in Northern Ireland, in Northern Ireland;]

(b)is marked “free medical sample – not for resale” or bears a similar description; and

(c)is accompanied by a copy of the summary of the product characteristics.

(6) Condition E is that the sample does not contain—

(a)a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or

(b)a substance which is listed in any of Schedules I to IV to the Psychotropic Substances Convention (where the product is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention).

(7) Condition F is that the supplier maintains an adequate system of control and accountability in relation to the supply of free samples.

Textual Amendments

Medical sales representativesU.K.

299.—(1) This regulation applies in relation to the promotion by a medical sales representative of medicinal products to persons qualified to prescribe or supply such products.

(2) During each visit for promotional purposes the representative must give to, or have available for, each person visited a copy of the summary of the product characteristics for each product promoted.

(3) The representative must report all information, with particular reference to any adverse reactions, that—

(a)is received from persons visited for promotional purposes; and

(b)relates to the use of a product promoted,

to the scientific service established in accordance with regulation 281(2) by the holder of the [F30UK marketing authorisation, EU marketing authorisation] certificate of registration, traditional herbal registration or Article 126a authorisation for the product.

Textual Amendments

Inducements and hospitalityU.K.

300.—(1) A person may not, in connection with the promotion of medicinal products to persons qualified to prescribe or supply them, supply, offer, or promise any gift, pecuniary advantage or benefit unless it is—

(a)inexpensive; and

(b)relevant to the practice of medicine or pharmacy.

(2) A person may not provide hospitality at a meeting or event held for the purposes of the promotion of a medicinal product unless—

(a)the hospitality is strictly limited to the main purposes of the meeting or event; and

(b)the person to whom it is provided or offered is a health care professional.

(3) Nothing in this regulation shall prevent any person providing hospitality at an event held for purely professional or scientific purposes provided that—

(a)the hospitality is strictly limited to the main scientific objective of the event; and

(b)the person to whom it is provided or offered is a health care professional.

(4) A person qualified to prescribe or supply medicinal products may not solicit or accept any gift, pecuniary advantage, benefit or hospitality that is prohibited by this regulation.

(5) In this regulation “hospitality” includes—

(a)sponsorship of a person's attendance at a meeting or event; and

(b)the payment of travelling or accommodation expenses.

(6) This regulation does not apply in relation to measures or trade practices relating to prices, margins or discounts that were in existence on 1st January 1993.

Homoeopathic medicinal productsU.K.

Advertisements for registered homoeopathic medicinal productsU.K.

301.—(1) A person may not publish an advertisement relating to a homoeopathic medicinal product to which a certificate of registration relates unless the advertisement meets the following conditions.

(2) Condition A is that the advertisement does not mention any specific therapeutic indications.

(3) Condition B is that the advertisement does not contain any details other than those mentioned in Schedule 28 (labelling requirements for registrable homoeopathic medicinal products).

(4) Nothing in regulation 291(2) (form and content of advertisement), 294 (general requirements) or 295 (abbreviated advertisements) requires an advertisement relating to a homoeopathic medicinal product to which a certificate of registration relates to contain any detail not specified in Schedule 28.

Traditional herbal medicinal productsU.K.

Advertisements for traditional herbal medicinal productsU.K.

302.  A person may not publish an advertisement relating to a herbal medicinal product to which a traditional herbal registration relates unless it contains—

(a)the words “Traditional herbal medicinal product for use in”; followed by

(b)a statement of one or more therapeutic indications for the product consistent with the terms of the registration; followed by

(c)the words “exclusively based on long standing use”.

OffencesU.K.

OffencesU.K.

303.—(1) A person is guilty of an offence if that person commits a breach of a provision in this Chapter.

(2) A breach of a provision in this Chapter includes any—

(a)contravention by any person of any prohibition in this Chapter; and

(b)failure by any person to comply with any requirement or obligation in this Chapter.

(3) A person guilty of an offence under this regulation other than one to which paragraph (4) applies is liable—

(a)on summary conviction to a fine not exceeding the statutory maximum; or

(b)on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.

(4) This paragraph applies to an offence consisting of a breach of—

(a)regulation 298(1) (free samples);

(b)regulation 299(2) or (3) (medical sales representatives); or

(c)regulation 300(4) (solicitation or acceptance of inducements or hospitality).

(5) A person guilty of an offence to which paragraph (4) applies is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

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