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The Human Medicines Regulations 2012

Changes over time for: Cross Heading: Advertising to the public

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Changes to legislation:

The Human Medicines Regulations 2012, Cross Heading: Advertising to the public is up to date with all changes known to be in force on or before 20 October 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. Help about Changes to Legislation

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Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):

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 [F1regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.) and] regulation 292 (exception for approved vaccination campaigns).

Textual Amendments

[F2Medicines 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 [F3regulation 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 [F4regulation 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).

[F5(5) Paragraph (2)(d) is subject to regulation 291A (campaigns relating to the suspected or confirmed spread of pathogenic agents etc.).]

Textual Amendments

[F6Campaigns 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.

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