Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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articles 4

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Submission of mock-ups of packaging and leaflets to licensing authority

267

(1) At the time when a person applies for a UK marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, the person must submit to the licensing authority—

(a) one or more mock-ups of the outer packaging and immediate packaging proposed for the product; and

(b) a draft package leaflet.

(2) If the application is for a UK marketing authorisation, Article 126a authorisation or traditional herbal registration, the person must also provide to the licensing authority the results of assessments of the packaging and package leaflet carried out in co-operation with target patient groups.

(3) The licensing authority must refuse the application for a UK marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration if—

(a) the packaging or the package leaflet does not comply with the requirements of this Part; or

(b) (in relation to an application for a UK marketing authorisation, Article 126a authorisation or traditional herbal registration) the information on the packaging or the package leaflet does not accord with the particulars listed in the summary of the product characteristics.

(4) If the holder of a UK marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a product wishes to make changes to the packaging or the package leaflet (other than a change connected with the summary of the product characteristics), the proposed change must be submitted to the licensing authority in accordance with paragraph (5).

(5) In the circumstances in paragraph (4) the holder must submit to the licensing authority such of the following as are affected by the proposed change—

(a) one or more mock-ups of the outer packaging and immediate packaging of the product showing the proposed change; and

(b) a draft package leaflet showing the proposed change.

(6) If the licensing authority has not refused a proposed change within the period of 90 days beginning with the date of the submission, the applicant may make the change.

Enforcement and offences

Offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc

268

(1) This regulation applies to the holder of a UKMA(UK), UKMA(GB), certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply , in Northern Ireland, a medicinal product to which the authorisation, certificate or registration relates.

(2) A person to whom this regulation applies is guilty of an offence if—

(a) a package or package leaflet relating to the product does not comply with the applicable requirements of this Part ... or regulation 50C(4), 50D(8) or 58A(2)(b); or

(b) the product is not accompanied by a package leaflet when one is required by virtue of this Part.

Offences relating to packaging and package leaflets: other persons

269

(1) This regulation applies to a person, other than the holder of a UKMA(UK), UKMA(GB), certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business carried on by that person, sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply , in Great Britain.

(2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, in Great Britain knowing or having reasonable cause to believe—

(a) that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part ... or regulation 50C(4), 50D(8) or 58A(2)(b); or

(b) that the product is not accompanied by a package leaflet when one is required by virtue of this Part.

Non-compliance with requirements of this Part

270

(1) If the holder of a UK marketing authorisation..., Article 126a authorisation, certificate of registration or traditional herbal registration fails to comply with a requirement imposed by this Part in relation to a medicinal product, the licensing authority may give a notice to the holder requiring compliance within three months or such other period (which may be less than three months) as may be specified in the notice.

(2) If the holder fails to comply with the notice, the licensing authority may suspend the UK marketing authorisation..., Article 126a authorisation, certificate of registration or traditional herbal registration until the holder complies with the requirements of this Part.

(3) A person who fails to comply with a notice under this regulation is guilty of an offence.

Offences: penalties

271

A person who is guilty of an offence under regulation 268, 268A, 269, 269A or 270 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.

CHAPTER 2 Requirements relating to child safety

Interpretation

272

In this Chapter—

“appropriate practitioner” means any of the persons described as appropriate practitioners in relation to any prescription only medicine in regulation 214(3), (5) and (6);

“regulated medicinal product” means a medicinal product containing aspirin, paracetamol or more than 24mg of elemental iron, in the form of tablets, capsules, pills, lozenges, pastilles, suppositories or oral liquids, but does not include—effervescent tablets containing not more than 25% of aspirin or paracetamol by weight;medicinal products in sachets or other sealed containers which hold only one dose;medicinal products which are not intended for retail sale or for supply in circumstances corresponding to retail sale; ormedicinal products which are for export only.

Child resistant containers for regulated medicinal products

273

(1) Regulated medicinal products sold or supplied otherwise than in accordance with regulation 274 may be sold only in containers which are—

(a) opaque or dark tinted; and

(b) child resistant.

(2) For the purposes of these Regulations, containers which are not reclosable are child resistant if they have been evaluated in accordance with, and comply with the requirements of—

(a) British Standard EN 14375:2003 published by the British Standards Institution on 18th April 2005; or

(b) any specification for non-reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).

(3) For the purposes of these Regulations, containers which are reclosable are child resistant if they have been evaluated in accordance with, and comply with the requirements of—

(a) British Standard EN ISO 8317:2004 published by the British Standards Institution on 11th May 2005; or

(b) any specification for reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).

Exemptions from regulation 273

274

(1) Regulation 273 does not apply to the retail sale, or supply in circumstances corresponding to retail sale, of regulated medicinal products in accordance with paragraph (2).

(2) Sale or supply is in accordance with this paragraph if the sale or supply is carried out—

(a) by or under the supervision of a pharmacist;

(b) at or from premises which are a registered pharmacy; and

(i) in accordance with a prescription given by an appropriate practitioner where it is not reasonably practicable to provide the regulated medicinal products in containers that are both opaque or dark tinted and child resistant, or

(ii) at the request of a person who is aged 16 or over and specifically requests that the regulated medicinal products not be contained in a child resistant container.

(3) Regulation 273 also does not apply to the sale or supply of regulated medicinal products—

(a) by a doctor or dentist to a patient, or the patient's carer, for the patient's use;

(b) by a doctor or dentist to a person who is an appropriate practitioner, at the request of that person, for administration to a patient of that person; or

(c) in the course of the business of a hospital or health centre, where the sale or supply is for the purposes of administration, whether in the hospital or health centre or elsewhere, in accordance with the directions of an appropriate practitioner.

Colouring of aspirin and paracetamol products for children

275

The sale or supply of a medicinal product containing aspirin or paracetamol of any colour other than white is prohibited if—

(a) it is a product for children aged 12 or under; and

(b) in the case of paracetamol, it is in a solid form (including tablets, capsules, pills, lozenges, pastilles or suppositories).

Offences

276

(1) A person is guilty of an offence if, in the course of a business, the person sells or supplies, or possesses for the purposes of sale or supply—

(a) a regulated medicinal product in a container which does not comply with the requirements of regulation 273, unless the sale or supply is or would be exempt from those requirements under regulation 274; or

(b) a medicinal product containing aspirin or paracetamol the sale or supply of which is prohibited under regulation 275.

(2) A person guilty of an offence under this regulation 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 2 years, or to both.

PART 14 — Advertising

CHAPTER 1 — General

Interpretation

277

(1) In this Part—

“court” means the High Court or, in Scotland, the Court of Session;

“holder of a temporary authorisation” means, where there is in force in relation to a medicinal product an authorisation by the licensing authority on a temporary basis under regulation 174 (but not an authorisation, certificate or registration as mentioned in regulation 281(1)(a) to (e)), the person who is responsible for placing that product on the market in the United Kingdom;

“injunction” (except in regulation 313) includes an interim injunction;

“OFCOM” means the Office of Communications;

“person qualified to prescribe or supply medicinal products” includes—persons who, in the course of their profession or in the course of a business, may lawfully—prescribe medicinal products,sell medicinal products by retail, orsupply medicinal products in circumstances corresponding to retail sale; andemployees of such persons;

“publication”, in relation to an advertisement, means the dissemination or issue of that advertisement—orally;in writing;by means of an electronic communications network within the meaning of the Communications Act 2003 ; orin any other way,and includes causing or procuring such publication by or on behalf of another person, and “publish” has a corresponding meaning.

(2) In the application of this Part to Scotland—

(a) references to an injunction are to be read as references to an interdict; and

(b) references to an interim injunction are to be read as references to an interim interdict.

Functions of the Ministers

278

A function of the Ministers under this Part may be exercised by either of them acting alone or both of them acting jointly (and references in this Part to “the Ministers” are to be read accordingly).

CHAPTER 2 — Requirements relating to advertising

General

Products without a marketing authorisation etc

279

(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);

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

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

(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);

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

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

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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.

General principles

280

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

(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.

(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 281(1)(a) to (e)), unless it is published as part of a campaign that has been approved by the Ministers.

Duties of authorisation holders and registration holders

281

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

(a) a UK marketing authorisation for a medicinal product;

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

(d) an Article 126a authorisation for a medicinal product ; ...

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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

Advertising to the public

Application of regulations 283 to 292

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 abortions

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 medicines

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

Narcotic and psychotropic substances

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

Material relating to diagnosis

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 product

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

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

Material about status of medicinal product

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 etc

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

Advertisements directed at children

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 advertisement

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;

(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).

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

Exception for approved vaccination campaigns

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 purposes

293

(1) The holder of either 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) ... 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.

Advertising to persons qualified to prescribe or supply etc

General requirements

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 paragraphs (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.

(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

(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.

(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).

(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

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

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

Abbreviated advertisements

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

(d) the name and address of the holder of 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) ... 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.

(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

(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).

Exception for advertisements intended as a reminder

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 promotions

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) subject 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.

(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;

(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.

Free samples for persons qualified to prescribe or supply medicinal products

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—

(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

(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.

Medical sales representatives

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 UK marketing authorisation, ... certificate of registration, traditional herbal registration or Article 126a authorisation for the product.

Inducements and hospitality

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 products

Advertisements for registered homoeopathic medicinal products

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 products

Advertisements for traditional herbal medicinal products

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

Offences

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

(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.

CHAPTER 3 — Monitoring of Advertising

Scrutiny by Ministers

Requirement to provide copy advertisement

304

(1) The Ministers may give a notice in writing under paragraph (2) or (3) to any person appearing to them to be concerned or likely to be concerned with the publication of advertisements relating to medicinal products.

(2) A notice under this paragraph is a notice that requires the person to whom it is given to provide the Ministers within a specified period with a copy of any advertisement that, as at the date of service of the notice, the person has published or proposes to publish and that relates to—

(a) a specified medicinal product; or

(b) medicinal products of a specified class or description.

(3) A notice under this paragraph is a notice that requires the person to whom it is given to provide the Ministers with a copy of any advertisement that the person proposes to publish during a specified period and that relates to—

(a) a specified medicinal product; or

(b) medicinal products of a specified class or description.

(4) The period specified in a notice under paragraph (3) must not exceed 12 months.

(5) A notice under paragraph (3) must specify the number of days before the proposed publication date of any advertisement by which a copy of the advertisement must be provided to the Ministers.

(6) A notice under paragraph (3) may be withdrawn by the Ministers before the expiry of the specified period.

(7) A notice under paragraph (2) or (3) may require the person to whom it is given not to publish, or further publish, during a specified period any advertisement a copy of which the person is required by the notice to provide to the Ministers.

(8) A notice under paragraph (2) or (3) must give the Ministers' reasons for giving the notice and (if appropriate) for imposing a requirement under paragraph (7).

(9) In this regulation “specified” means specified in the notice.

Invitation to make representations about compatibility

305

(1) This regulation applies if, having considered an advertisement a copy of which is obtained by them pursuant to a notice given under regulation 304 or by some other means, the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2.

(2) The Ministers may give a notice in writing under this regulation to any person appearing to them to be concerned or likely to be concerned with the publication of the advertisement.

(3) A notice under this regulation must—

(a) state that the Ministers are minded to make a determination under regulation 306 that the advertisement is incompatible with the prohibitions imposed by Chapter 2 and specify whether the incompatibility is insofar as the advertisement is for publication—

(i) in Great Britain;

(ii) in Northern Ireland; or

(iii) in both Great Britain and Northern Ireland;

(b) give the reasons why they are minded to make the determination;

(c) state that the person to whom it is given may make written representations to the Ministers within the period of 21 days beginning immediately after the date of the notice as to why the advertisement is compatible with the prohibitions imposed by Chapter 2; and

(d) refer to the action that may be taken by the Ministers under regulation 306.

(4) A notice under this regulation may require the person to whom it is given not to publish, or to cease to publish, the advertisement

(a) in Great Britain;

(b) in Northern Ireland; or

Decision about compatibility

306

(1) This regulation applies if the Ministers have given a notice under regulation 305 (“the original notice”) to a person.

(2) After the end of the period of 21 days referred to in that regulation, the Ministers must give a further notice in writing (“the new notice”) to that person of their determination whether the advertisement is compatible with the prohibitions imposed by Chapter 2 and specify whether the incompatibility is insofar as the advertisement is for publication—

(a) in Great Britain;

(b) in Northern Ireland; or

(3) In making that determination, the Ministers must take account of any representations made in accordance with that regulation.

(4) If—

(a) the Ministers make a determination that the advertisement is compatible with the prohibitions imposed by Chapter 2 insofar as the advertisement is for publication—

(i) in Great Britain;

(ii) in Northern Ireland; or

(iii) in both Great Britain and Northern Ireland; and

(b) the original notice imposed a requirement under regulation 305(4),

the new notice must provide that the requirement no longer applies in Great Britain, Northern Ireland, or both Great Britain and Northern Ireland (as appropriate).

(5) The following provisions apply if the Ministers make a determination that the advertisement is incompatible with the prohibitions imposed by Chapter 2 insofar as the advertisement is for publication—

(a) in Great Britain;

(b) in Northern Ireland; or

(6) The new notice must give the Ministers' reasons for the determination.

(7) If the original notice imposed a requirement under regulation 305(4), the new notice may provide—

(a) that the requirement is to continue to apply; or

(b) that the requirement no longer applies ,

and where that original notice related to both Great Britain and Northern Ireland, the new notice may be expressed to apply in relation to either of or both Great Britain and Northern Ireland.

(8) If the original notice did not impose a requirement under regulation 305(4), the new notice may require the person to whom it is given not to publish, or to cease to publish, the advertisement

(a) in Great Britain;

(b) in Northern Ireland; or

Corrective statement

307

(1) This regulation applies if the new notice—

(a) maintains the application of a requirement imposed under regulation 305(4) to cease to publish the advertisement that is the subject of the notice in—

(i) Great Britain;

(ii) Northern Ireland; or

(iii) both Great Britain and Northern Ireland; or

(b) imposes a requirement to cease to publish that advertisement in—

(i) Great Britain;

(ii) Northern Ireland; or

(iii) both Great Britain and Northern Ireland.

(2) The new notice may require the person to whom it is given to publish—

(a) the Ministers' reasons for making the determination that the advertisement was incompatible with the prohibitions imposed by Chapter 2 in respect of—

(i) Great Britain;

(ii) Northern Ireland; or

(iii) both Great Britain and Northern Ireland,

either in full or in part; and

(b) a corrective statement concerning the advertisement.

(3) A requirement imposed under paragraph (2)—

(a) must specify the time within which publication must take place; and

(b) may specify the form of publication.

Offences

308

(1) A person is guilty of an offence if that person fails to comply with a requirement imposed by a notice given to that person under—

(a) regulation 304(2) or (3);

(b) regulation 305(4) (including such a notice as maintained under regulation 306(7)); or

(2) A person guilty of an offence under paragraph (1) 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.

(3) A person is guilty of an offence if that person fails to comply with a requirement imposed on that person under regulation 307(2).

(4) A person guilty of an offence under paragraph (3) is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Complaints to Ministers

Complaints to Ministers: duty to consider

309

(1) This regulation applies if a person makes a complaint to the Ministers that an advertisement that has been published, or that is proposed to be published, is incompatible with the prohibitions imposed by Chapter 2.

(2) Subject to the following provisions of this regulation and to regulation 310, the Ministers must consider the complaint unless it appears to the Ministers to be frivolous or vexatious.

(3) The Ministers are not under any duty to consider a complaint if either OFCOM or a body that appears to the Ministers to be a self-regulatory body that deals with complaints about advertisements of the type in question is already dealing with the same complaint.

(4) If the Ministers have served a notice in respect of the advertisement under regulation 305 (whether or not they have taken action in respect of it under regulation 306) they—

(a) may consider the complaint; but

(b) are not under any duty to do so.

(5) If the complaint is one that OFCOM would be under a duty to consider if it had been made to OFCOM (see regulation 314) the Ministers must—

(a) investigate the complaint; or

(b) seek the agreement of the complainant to the complaint being referred to OFCOM.

(6) If, within a reasonable time of being approached by the Ministers, the complainant agrees to the complaint being referred to OFCOM the Ministers must refer the complaint to OFCOM.

(7) If, within a reasonable time of being approached by the Ministers, the complainant does not agree to the referral of the complaint, the Ministers must consider the complaint.

(8) The Ministers must also consider the complaint if, having referred it to OFCOM, OFCOM—

(a) decides not to consider the complaint because it appears to OFCOM to be frivolous or vexatious; or

(b) fails to deal adequately with the complaint within a reasonable time of the referral being made.

Complaints to Ministers: power to refer

310

(1) This regulation applies if—

(a) a person (“the complainant”) makes a complaint within paragraph (2) to the Ministers that an advertisement that has been published, or that it is proposed be published, is incompatible with the prohibitions imposed by Chapter 2; and

(b) the complaint does not appear to the Ministers to be frivolous or vexatious.

(2) A complaint is within this paragraph if—

(a) it is a complaint that the advertisement contains material prohibited by any of regulations 286 to 290, but is not a complaint that OFCOM would be under a duty to consider if it had been made to OFCOM (see regulation 314); or

(b) it is a complaint that the advertisement is incompatible with any of the prohibitions imposed by regulations 294 to 300.

(3) The Ministers may—

(a) select a body that appears to them to be a self-regulatory body that deals with complaints about advertisements of the type in question (“the appropriate body”); and

(b) seek the agreement of the complainant to the complaint being referred to the appropriate body.

(4) If within a reasonable time of being approached by the Ministers the complainant agrees to the complaint being referred to the appropriate body, the Ministers must refer the complaint to that body.

(5) If within a reasonable time of being approached by the Ministers the complainant does not agree to the referral of the complaint, the Ministers must consider the complaint.

(6) The Ministers must also consider the complaint if, having referred it to the appropriate body—

(a) the appropriate body decides not to consider the complaint because it appears to the body to be frivolous or vexatious; or

(b) the Ministers think that the appropriate body has failed to deal adequately with the complaint within a reasonable time of the referral being made.

(7) But if the Ministers have served a notice in respect of the advertisement under regulation 305 (whether or not they have taken action in respect of it under regulation 306)—

(a) the duties in paragraphs (4) to (6) do not apply; and

(b) each of those paragraphs has effect as if it conferred a power on the Ministers to act as mentioned in that paragraph.

Injunctions

Application for injunction

311

(1) This regulation applies—

(a) if the Ministers consider that an advertisement that has been published, or that is proposed to be published, is incompatible with the prohibitions imposed by Chapter 2 in respect of—

(i) Great Britain;

(ii) Northern Ireland; or

(iii) both Great Britain and Northern Ireland; and

(b) whether or not a complaint has been made to the Ministers or to any other person.

(2) The Ministers may apply to the court for an injunction against any person appearing to them to be concerned or likely to be concerned with the publication of the advertisement.

(3) On the making of an application under paragraph (2), the court may grant an injunction prohibiting the publication, or further publication, of the advertisement in—

(i) Great Britain;

(ii) Northern Ireland; or

(iii) both Great Britain and Northern Ireland,

as the case may be.

(4) An injunction granted under paragraph (3) may also prohibit the publication, or further publication, of any advertisement in similar terms or likely to convey a similar impression.

(5) The court may not refuse to grant an injunction for lack of evidence that—

(a) the publication, or proposed publication, of the advertisement has given rise to loss or damage to any person; or

(b) the person responsible for the advertisement intended it to be incompatible with the prohibitions imposed by Chapter 2 or failed to exercise proper care to prevent it from being so incompatible.

(6) The court must give its detailed reasons in writing for its decision to grant or refuse an injunction.

(7) Where the court grants an injunction, the Ministers must as soon as is reasonably practicable provide the following in writing to each person against whom the injunction has been granted—

(a) the court's reasons for granting the injunction;

(b) any remedy available in the court; and

Application for injunction: accuracy of factual claim

312

(1) This regulation applies if—

(a) an application for an injunction is made under regulation 311; and

(b) the advertisement in question makes a factual claim about the medicinal product to which it relates.

(2) The court may require any person appearing to it to be responsible for the advertisement to provide evidence as to the accuracy of the factual claim.

(3) The court may impose a requirement under paragraph (2)—

(a) on the application of any party to the proceedings for the injunction; or

(b) of its own motion.

(4) In deciding whether or not to impose a requirement under paragraph (2) the court must have regard to the interests of any person who would be subject to, or affected by, the requirement.

(5) A requirement imposed under paragraph (2) must specify the time within which the evidence must be provided.

(6) If the person on whom a requirement is imposed under paragraph (2) fails to comply with it the court may infer that the factual claim is inaccurate.

(7) A person may fail to comply with a requirement imposed under paragraph (2) by—

(a) not providing any evidence; or

(b) providing evidence that the court considers inadequate.

Grant of injunction: publication of decision and corrective statement

313

(1) This regulation applies if the court grants an injunction under regulation 311, other than an interim injunction, in respect of an advertisement that has been published.

(2) The Ministers may by notice in writing require any person against whom the injunction has been granted to publish—

(a) all or part of the court's decision; and

(b) a corrective statement concerning the advertisement in respect of which the application for the injunction was made.

(3) A requirement imposed under paragraph (2)—

(a) must specify the time within which publication must take place; and

(b) may specify the form of publication.

(4) If a person (“P”) fails to comply with a requirement imposed under paragraph (2) the Ministers may certify that failure to the court and the court may enquire into the matter.

(5) If the court enquires into the matter it must as part of its enquiry—

(a) hear any witnesses produced against or on behalf of P; and

(b) consider any statement offered in P's defence.

(6) If having conducted its enquiry the court is satisfied that P failed without reasonable excuse to comply with a requirement imposed under paragraph (2) it may deal with P as if P were in contempt of court.

Complaints to OFCOM

314

(1) This regulation applies if OFCOM—

(a) receives from a person a complaint that an advertisement that contains material prohibited by any of regulations 286 to 290 (“prohibited material”) has been included in—

(i) a licensed service, or

(ii) S4C Digital or a service provided by the Welsh Authority under section 205 of the Communications Act 2003 (“the 2003 Act”); or

(b) has a complaint as described in sub-paragraph (a) referred to it by the Ministers under regulation 309(5) and (6).

(2) OFCOM must consider the complaint unless—

(a) the complaint appears to it to be frivolous or vexatious; or

(b) paragraph (3) applies.

(3) If the Ministers have served a notice in respect of the advertisement under regulation 305 (whether or not they have taken action in respect of it under regulation 306) OFCOM—

(a) may consider the complaint; but

(b) is not subject to any duty to do so.

(4) If, having considered the complaint, OFCOM considers that the advertisement contains prohibited material it may—

(a) in the case of an advertisement that has been included in a licensed service, give to the person who is the holder of the licence in respect of that service a direction to exclude the advertisement from the licensed service; and

(b) in the case of an advertisement that has been included in S4C Digital or a service provided by the Welsh Authority under section 205 of the 2003 Act, give to the Welsh Authority a direction to exclude the advertisement from S4C Digital or the service provided under section 205 of the 2003 Act.

(5) If OFCOM gives a direction under paragraph (4), it may also give a direction to the licence holder or (as the case may be) the Welsh Authority to exclude from the service any advertisement in similar terms or likely to convey a similar impression.

(6) In deciding whether or not to exercise its power to give a direction under paragraph (4), OFCOM must disregard any lack of evidence that—

(a) the publication of the advertisement has given rise to loss or damage to any person; or

(b) the person responsible for the advertisement intended it to be incompatible with the prohibitions imposed by Chapter 2 or failed to exercise proper care to prevent it from being so incompatible.

(7) A direction given under this regulation to a licence holder is to be treated for the purposes of the 2003 Act as a direction with respect to a matter mentioned in section 325(5) of that Act.

(8) A direction given under this regulation to the Welsh Authority is to be treated for the purposes of the Communications Act 2003 Act as a direction with respect to a matter mentioned in paragraph 14(2) of Schedule 12 to that Act.

(9) If OFCOM gives a direction under this regulation, it must inform the licence holder or (as the case may be) the Welsh Authority in writing of its reasons for doing so.

(10) In this regulation—

“licensed service” means a service in respect of which OFCOM has granted a licence under Part 1 or 3 of the Broadcasting Act 1990 or Part 1 or 2 of the Broadcasting Act 1996 ;

“S4C Digital” means the television service provided in digital form and known as S4C Digital; and

“Welsh Authority” means the authority whose name is, by virtue of section 56(1) of the Broadcasting Act 1990 , Sianel Pedwar Cymru.

General

Public interest etc

315

In exercising the functions conferred on them by this Chapter, the Ministers, the court and OFCOM must have regard, in particular, to the public interest.

Civil proceedings

316

In exercising the functions conferred on them by this Chapter, the Ministers may institute civil proceedings in their own name.

PART 15 — British Pharmacopoeia

British Pharmacopoeia and compendia

317

(1) The British Pharmacopoeia Commission (in this Part referred to as “the BPC”) must, at such intervals as it thinks appropriate, prepare or cause to be prepared editions of the British Pharmacopoeia, containing such relevant information relating to substances, combinations of substances and articles falling within paragraph (2) as the BPC thinks appropriate.

(2) The substances, combinations of substances, and articles falling within this paragraph are—

(a) substances, combinations of substances and articles (whether medicinal products or not) which are or may be used in the practice of medicine or surgery (other than veterinary medicine or veterinary surgery), dentistry or midwifery; and

(b) substances, combinations of substances and articles used in the manufacture of anything falling within paragraph (a).

(3) The BPC may also, at such intervals as it thinks appropriate, prepare or cause to be prepared—

(a) a compendium (other than the British Pharmacopoeia) containing such relevant information relating to substances, combinations of substances and articles within paragraph (2) as the BPC thinks appropriate; and

(b) a compendium containing such relevant information as the BPC thinks appropriate in relation to—

(i) substances, combinations of substances and articles (whether veterinary medicinal products or not) which are or may be used in the practice of veterinary medicine or veterinary surgery; and

(ii) substances, combinations of substances and articles used in the manufacture of anything falling within sub-paragraph (i).

(4) The Ministers must arrange for the publication of anything prepared or caused to be prepared by the BPC under this regulation.

(5) In this Part—

(a) a reference to preparing a thing or causing it to be prepared includes amending it, or causing it to be amended;

(b) a reference to publication includes publication by electronic means; and

(c) “relevant information”, in relation to a substance, combination of substances or article, means information consisting of descriptions of, standards for, or notes or other matter relating to the substance, combination of substances or article.

Lists of names

318

(1) The BPC must, at such intervals as it thinks appropriate, prepare or cause to be prepared a list of names which appear to it to be suitable—

(a) to be used as the names of substances, combinations of substances or articles falling within regulation 317(2) or (3)(b); and

(b) to be placed at the head of monographs relating to those substances, combinations of substances or articles in any edition of the British Pharmacopoeia or in a compendium prepared under that regulation.

(2) Where a list has been prepared in accordance with paragraph (1), the Ministers must cause it to be published.

Supplementary provisions

320

(1) Anything published in accordance with a provision of this Part (other than regulation 319 (“a publication”) must specify the date on which it is to take effect.

(2) The Ministers must give notice of the date mentioned in paragraph (1) by notices published in the London, Edinburgh and Belfast Gazettes not less than 21 days before that date.

(3) Where in any proceedings an enforcement authority produces a copy of a publication, it shall be presumed that the copy is a true copy of the edition of that publication that was in force at the time when the events that are the subject of the proceedings took place, unless evidence is adduced to the contrary.

Specified publications

321

(1) In this regulation “specified publication” means any of the following—

(a) the European Pharmacopoeia;

(b) the British Pharmacopoeia;

(d) a compendium prepared and published under regulation 317; or

(e) a list of names prepared and published under regulation 318.

(2) Paragraph (3) applies if an authorisation refers to a specified publication, but not to a particular edition of the publication.

(3) Where this paragraph applies, in order to determine whether anything done at a time when the authorisation is in force is done in accordance with the authorisation, the reference to a specified publication is to be construed as a reference to the edition of the specified publication in force at that time, unless the authorisation expressly provides otherwise.

(4) In paragraph (3) the reference to the edition of a specified publication in force at a particular time is a reference to the edition of that publication in force, under whatever title, at that time.

(5) In this regulation “authorisation” means any of the following—

(a) a manufacturer's licence;

(b) a wholesale dealer's licence;

(ca) ...

(d) an Article 126a authorisation;

(e) a certificate of registration; or

(f) a traditional herbal registration.

PART 16 — Enforcement

Validity of decisions and proceedings

322

(1) The validity of a decision of the licensing authority under Parts 3 (manufacturing and wholesale dealing), 5 (UK marketing authorisations), 6 (certification of homoeopathic medicinal products), 7 (traditional herbal medicinal products) or 8 (Article 126a authorisations) is not to be questioned in any legal proceedings.

(2) The validity of a licence, authorisation, certificate or registration granted or issued, or other thing done, in pursuance of a decision of a kind mentioned in paragraph (1) is not to be questioned in any legal proceedings.

(3) Paragraphs (1) and (2) are subject to the following provisions of this regulation.

(4) A person to whom notice of the decision is given may make an application to the High Court to challenge the validity of the decision on the grounds that—

(a) the decision is not within the powers conferred on the licensing authority; or

(b) a requirement of these Regulations in connection with the matter to which the decision relates has not been complied with.

(5) An application under paragraph (4) must be made within the period of three months beginning immediately after the day on which notice of the decision is given to the applicant.

(6) On an application under paragraph (4) the High Court may—

(a) make an interim order suspending the operation of the decision to which the application relates until the final determination of proceedings; or

(b) quash the decision, if satisfied that—

(i) the decision is not within the powers conferred by these Regulations, or

(ii) the interests of the applicant have been substantially prejudiced by a failure to comply with a requirement under these Regulations.

(7) If a decision to grant a licence, authorisation, certificate or registration is quashed under this regulation—

(a) a licence, authorisation, certificate or registration granted in pursuance of the decision is void; and

(b) the application process for the grant of the licence, authorisation, certificate or registration may be continued as if the decision had not been made.

(8) In the application of this regulation to Scotland, references to the High Court are to be construed as references to the Court of Session.

Enforcement in England, Wales and Scotland

323

(1) The Secretary of State must enforce or secure the enforcement of these Regulations ... in England, Wales and Scotland.

(2) The Secretary of State may make arrangements for either or both of—

(a) the General Pharmaceutical Council; or

(b) in respect of each area for which there is a drugs authority, the drugs authority for the area,

to enforce the provisions of these Regulations listed in paragraph (3) to the extent specified in the arrangements.

(3) The provisions referred to in paragraph (2) are—

(a) regulations 251 (compliance with standards specified in certain publications) and 255(1)(e) (offences relating to dealings with medicinal products: compliance with standards specified in certain publications);

(b) Part 13 (packaging and leaflets); ... and

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Arrangements made with the General Pharmaceutical Council under paragraph (2)(a) in relation to Part 14 Chapter 2 are to be limited to the enforcement of those provisions in respect of—

(a) advertisements displayed or representations made on or in any premises where medicinal products are sold by retail or supplied in circumstances corresponding to retail sale;

(b) advertisements displayed on any web site associated with such premises; and

(c) advertisements displayed on, or in close proximity to, a vending machine in which medicinal products are offered or exposed for sale.

(4A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) The General Pharmaceutical Council must continue to enforce—

(a) regulations 214 (sale or supply of prescription only medicines) and 220 (sale or supply of medicines not subject to general sale); and

(b) in their application to or in relation to premises that are registered pharmacies, the provisions of these Regulations to which paragraph (7) applies.

(6) In each area for which there is a drugs authority, that drugs authority must continue to enforce the provisions of these Regulations to which paragraph (7) applies in their application to or in relation to premises that are not registered pharmacies.

(7) This paragraph applies to regulations 221 (sale or supply of medicinal products subject to general sale) and 222 (sale of medicinal products from automatic machines).

(8) Functions conferred by virtue of paragraphs (2), (5) and (6) are to be exercised concurrently with the Secretary of State.

(9) Nothing in this regulation confers a function on a person in relation to—

(a) a hospital (except so much of the hospital as is a registered pharmacy); or

(b) so much of any premises as is used as a doctor's or dentist's practice.

(10) In this regulation “drugs authority” means—

(a) in England—

(i) in relation to a non-metropolitan county, metropolitan district or London borough, the council of that county, district or borough, and

(ii) in relation to the City of London (including the Inner Temple and the Middle Temple), the Common Council of the City of London;

(b) in Wales, the council of a county or county borough; and

(c) in Scotland, a council constituted in relation to a local government area under section 2 of the Local Government etc (Scotland) Act 1994 .

(11) In this Part “premises” includes—

(a) any place; and

(b) a ship, aircraft, hovercraft or vehicle.

(12) Nothing in this regulation is to be construed as authorising any person other than the Lord Advocate or a procurator fiscal to institute proceedings in Scotland for an offence.

Enforcement in Northern Ireland

324

(1) The Minister for Health, Social Services and Public Safety (in this regulation referred to as “the Minister”) must enforce or secure the enforcement of these Regulations and the relevant EU provisions in Northern Ireland.

(2) The Minister may make arrangements for a district council to enforce the provisions of these Regulations listed in paragraph (3) in its district to the extent specified in the arrangements.

(3) Those provisions are—

(a) regulations 221 (sale or supply of medicinal products subject to general sale), 222 (sale of medicinal products from automatic machines) and 255(6) (certain offences relating to dealings with medicinal products);

(b) regulations 251 (compliance with standards specified in certain publications) and 255(1)(e) (certain offences relating to dealings with medicinal products);

(d) Part 14 Chapter 2 (requirements relating to advertising).

(4) Functions conferred by virtue of paragraph (2) are to be exercised concurrently with the Minister.

(5) Regulation 323(9) has effect in relation to functions conferred by this regulation as it has effect in relation to functions conferred by regulation 323.

(6) In this regulation, “district council” means a council established under the Local Government Act (Northern Ireland) 1972 .

Rights of entry

325

(1) An inspector may at any reasonable time enter premises—

(a) in order to determine whether there has been a contravention of a provision of these Regulations which the enforcement authority is required or empowered to enforce by virtue of regulations 323 and 324;

(b) in order to verify whether the data submitted in respect of an active substance used as a starting material in order to obtain a conformity certificate issued by the European Directorate for the Quality of Medicines and Healthcare (“EDQM”) comply with the monographs of the European Pharmacopoeia, if the EDQM asks the enforcement authority to do so; and

(2) A person may not exercise a right of entry under this regulation in relation to premises used only as a private dwelling unless 24 hours' notice has been given to the occupier.

(3) A person exercising, or attempting to exercise, a right of entry under this regulation must produce identification on request.

Application for warrant

326

(1) In a case where this regulation applies, a justice of the peace may issue a warrant authorising an inspector to enter premises, by force if necessary.

(2) This regulation applies if, on sworn information in writing, the justice of the peace is satisfied that—

(a) there are reasonable grounds for entering the premises by virtue of the enforcement authority's functions under these Regulations;

(b) an inspector has a right to enter them by virtue of regulation 325; and

(3) Those conditions are—

(a) that—

(i) admission to the premises has been refused or is expected to be refused, and

(ii) notice of the intention to apply for a warrant has been given to the occupier;

(b) that a request for admission, or the giving of notice, would defeat the object of the entry;

(d) that the premises are unoccupied or the occupier is temporarily absent.

(4) In relation to a ship, aircraft, hovercraft or vehicle, references in this Part to the occupier of premises are to be read as references to the master, commander or other person in charge of the ship, aircraft, hovercraft or vehicle.

(5) A warrant granted under this regulation continues in force for a period of 30 days beginning with the day on which the warrant is granted.

(6) In the application of this regulation to England, references to a justice of the peace include a reference to a district judge (magistrates' courts).

(7) In the application of this regulation to Scotland, references to a justice of the peace are to be read as references to a sheriff, stipendiary magistrate or justice of the peace.

(8) In the application of this regulation to Northern Ireland, references to a justice of the peace are to be read as references to a lay magistrate or a district judge (magistrates' courts).

Powers of inspection, sampling and seizure

327

(1) An inspector may inspect anything mentioned in paragraph (2)—

(a) in order to determine whether there has been a contravention of any provision of these Regulations which the enforcement authority must or may enforce by virtue of regulations 323 and 324;

(b) for the purpose described in regulation 325(1)(b) (verification of data at the request of the European Directorate for the Quality of Medicines and Healthcare); or

(i) a manufacturer’s licence,

(ii) a wholesale dealer’s licence,

(iii) a brokering registration,

(iv) registration as an importer, manufacturer or distributor of active substances,

(v) a UK marketing authorisation,

(va) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(vi) a certificate of registration,

(vii) a traditional herbal registration, or

(viii) an Article 126a authorisation;

(d) in relation to a person’s notification to sell medicinal products at a distance under Part 12A.

(2) The things mentioned in paragraph (1) are—

(a) a substance or article appearing to the inspector to be a medicinal product or an active substance;

(b) an article appearing to the inspector to be—

(i) a container or package used or intended to be used to contain a medicinal product or an active substance, or

(ii) a label or leaflet used or intended to be used in connection with a medicinal product or an active substance;

(c) plant or equipment, including computer equipment, appearing to the inspector to be used or intended to be used in connection with the manufacture, assembly, importation, sale, supply or advertising of, or wholesale dealing in, medicinal products or active substances;

(d) any process of manufacture or assembly of medicinal products or active substances;

(e) the way in which medicinal products or active substances, or the materials used in the manufacture of medicinal products or active substances, are tested at any stage in the process of manufacture or assembly;

(f) information and documents relating to the manufacture, assembly, importation, sale, supply or advertising of, or wholesale dealing in, medicinal products or active substances;

(g) information and documents relating to the safety of medicinal products or active substances, including information and documents relating to compliance with—

(i) conditions imposed under any of regulations 59 (conditions of UK marketing authorisation: general), 60 (conditions of UK marketing authorisation: exceptional circumstances), 61 (conditions of UK marketing authorisation: new obligations post-authorisation) or 105 (conditions of certificate of registration),

(ii) the requirements of Part 11 (pharmacovigilance),

(iii) obligations and conditions under Articles 10a(1), 14(7), 14(8), 16 or 57(2) of Regulation (EC) No 726/2004,

(iv) the requirements of Chapter 3 (pharmacovigilance) of Title II of Regulation (EC) No 726/2004,

(iva) the requirements of Schedule 12A (further provision as to the performance of pharmacovigilance activities);

(v) the requirements of the Implementing Regulation as defined in regulation 177(5) (pharmacovigilance: interpreting provision), and

(vi) obligations under regulations 75 (obligation to provide information relating to safety) and 76 (obligation in relation to product information);

(h) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The inspector may for the purposes specified in paragraph (1) take or purchase a sample of a substance or article which appears to the inspector to be—

(a) a medicinal product or an active substance which is, or is intended to be, sold or supplied; or

(b) a substance or article used, or intended to be used, in the manufacture of a medicinal product or an active substance.

(4) The inspector may for the purposes specified in paragraph (1) require a person carrying on a business which consists of or includes the manufacture, assembly, importation, sale, supply or advertising of, or wholesale dealing in, medicinal products or active substances, or a person employed in connection with such a business, to produce information or documents relating to the business which are in the person’s possession or under the person’s control.

(4A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) The inspector may take copies of information or documents—

(a) inspected under sub-paragraph (2)(f) or (g); or

(b) produced under paragraph (4) ....

(6) The inspector may seize and retain a substance or article appearing to the inspector to be a medicinal product or an active substance if the inspector reasonably believes that an offence under these Regulations is being or has been committed in relation to, or by means of, that substance or article.

(7) The inspector may, if the inspector reasonably believes that it may be required as evidence in proceedings, seize and retain—

(a) any document; or

(b) anything inspected, or discovered in the course of an inspection, under paragraph (1).

(8) The inspector may, if necessary, require a person who has the authority to do so—

(a) to open a container or package;

(b) to open a vending machine; or

for the purpose of enabling the inspector to seize a substance, article, document or other thing under paragraph (6) or (7).

(9) The information and documents referred to in this regulation include any that are stored electronically.

Regulation 327: supplementary

328

(1) Where an inspector seizes a substance, article, document or other thing under regulation 327(6) or (7) (powers of inspection, sampling and seizure) the inspector—

(a) must, where practicable, inform—

(i) the person, if any, from whom it was seized, and

(ii) the occupier of the premises from which it was seized; or

(b) in relation to anything seized from a vending machine, must inform—

(i) the person whose name and address are stated on the machine to be those of the machine's owner, or

(ii) if no name and address are stated, the occupier of the premises on which the machine stands or to which it is affixed.

(2) An inspector exercising, or attempting to exercise, a right under regulation 327 must produce identification on request.

(3) The provisions of Schedule 31 have effect in relation to samples obtained by inspectors on behalf of enforcement authorities.

Application of sampling procedure to substance or article seized under this Part

329

(1) This regulation applies where an inspector seizes a substance or article under regulation 327 (powers of inspection, sampling and seizure).

(2) On request in accordance with paragraph (3), the inspector must either—

(a) set aside a sample of the substance or article seized; or

(b) treat the substance or article as a sample,

whichever seems more appropriate having regard to the nature of the substance or article.

(3) A request is made in accordance with this paragraph if—

(a) it is made by a person (“P”) who is entitled to be informed of the seizure under regulation 328; and

(b) it is made either at the time of the seizure or within the period of 21 days beginning with the day immediately after the day on which P is informed of the seizure.

(4) An inspector is not required by paragraph (2) to set aside a sample, or to treat a substance or article as a sample, if the nature of the substance or article is such that it is not reasonably practicable to do either of those things.

(5) An inspector must—

(a) divide a sample under paragraph (2) into three parts;

(b) mark each part;

(d) supply one part to P.

(6) Paragraphs 10 to 12 and 15 to 26 of Schedule 31 apply to a sample under this regulation as they apply to a sample obtained as mentioned in paragraph 1 of that Schedule, but as if—

(a) references to the preceding provisions of that Schedule were references to the preceding provisions of this regulation;

(b) references to a sampling officer were references to an inspector who seized a substance or article under regulation 327 (powers of inspection, sampling and seizure); and

(c) a reference to the relevant enforcement authority were a reference to the authority by which the inspector is authorised.

Analysis of samples: other cases

330

(1) This regulation applies where a person other than an inspector or a person authorised by an enforcement authority has purchased an active substance or a medicinal product.

(2) The person may submit a sample of the active substance or medicinal product for analysis to the public analyst for the area in which the active substance or medicinal product was purchased or, if for the time being there is no public analyst for the area, to the public analyst for another area.

(3) Paragraphs 2 to 13 of Schedule 31 have effect, in relation to a person proposing to submit a sample in pursuance of paragraph (2), as if in that Schedule references to the sampling officer were references to that person.

(4) A public analyst to whom a sample is submitted under this regulation must analyse the sample, or cause it to be analysed, as soon as practicable (but this is subject to the following provisions of this regulation).

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