MEDICINES Citation, commencement and interpretation 1 1 These Regulations may be cited as the Medicines (Advertising and Monitoring of Advertising) Amendment Regulations 1999 and shall come into force on 5th April 1999. 2 In these Regulations– “the Advertising Regulations ” means the Medicines (Advertising) Regulations 1994 ; and “the Monitoring of Advertising Regulations ” means the Medicines (Monitoring of Advertising) Regulations 1994 . Amendment of regulation 2 of the Advertising Regulations 2 In regulation 2 of the Advertising Regulations (interpretation)– a in paragraph (1)– i after the definition of “name” there shall be inserted the following definition– “persons qualified to prescribe or supply” includes persons, and employees of such persons, who in the course of their profession or in the course of a business may lawfully prescribe, sell by retail or supply in circumstances corresponding to retail sale relevant medicinal products; , and ii in the definition of “relevant medicinal product” after the words “Directive apply” in paragraph (a) there shall be added the words “and accordingly includes products to which Title II of Council Regulation 2309/93 applies”; and b after paragraph (3) there shall be inserted the following paragraph– 4 In these Regulations, “the Health Ministers” means the Ministers specified in section 1(1)(a) of the Act, and the functions of the Health Ministers under these Regulations may be performed by any one of them acting alone or any two or more of them acting jointly. . Insertion of regulation 3A into the Advertising Regulations 3 After regulation 3 of the Advertising Regulations (prohibition of advertisements for unlicensed products) there shall be inserted the following regulation– General principles 3A 1 No person shall issue an advertisement relating to a relevant medicinal product unless that advertisement complies with the particulars listed in the summary of product characteristics. 2 No person shall issue an advertisement relating to a relevant medicinal product unless that advertisement encourages the rational use of that product by presenting it objectively and without exaggerating its properties. 3 No person shall issue a misleading advertisement relating to a relevant medicinal product. . Amendment of regulation 4 of the Advertising Regulations 4 For paragraphs (c) and (d) of regulation 4 of the Advertising Regulations (duties of licence holders) there shall be substituted the following– c keep available for the Health Ministers, or communicate to them within such period as may be specified in a notice served by them on him, a sample of any advertisement for which he is responsible relating to that product, together with a statement indicating the persons to whom the advertisement is addressed, the method of dissemination and the date of first dissemination; and d supply, within the period specified in a notice served by the Health Ministers on him, any information and assistance requested by them in order to carry out their functions under these Regulations or the Medicines (Monitoring of Advertising) Regulations 1994 . . Substitution of regulation 12 of the Advertising Regulations 5 For regulation 12 of the Advertising Regulations (prohibition of supply of medicinal products to the public) there shall be substituted the following regulation– Prohibition of supply of medicinal products to the public 12 No person– a being the holder of a marketing authorization; or b in the course of a business carried on by him and consisting (wholly or partly) of manufacturing relevant medicinal products or of selling or supplying relevant medicinal products, shall for a promotional purpose (whether a promotional purpose of his own or of a third party) sell or supply any relevant medicinal product to any member of the public. . Amendment of heading to regulation 14 of the Advertising Regulations 6 For the heading to regulation 14 of the Advertising Regulations (advertisements to health professionals) there shall be substituted “ Advertising to persons qualified to prescribe or supply ”. Amendment of regulation 20 of the Advertising Regulations 7 In paragraph (1) of regulation 20 of the Advertising Regulations (medical sales representatives) after the words “qualified to prescribe” there shall be inserted the words “or supply”. Amendment of regulation 23 of the Advertising Regulations 8 In regulation 23 of the Advertising Regulations (offences)– a in paragraph (1)– i after “3(1),” there shall be inserted “3A,”, and ii after “10(1),” there shall be inserted “12,”; and b after paragraph (2) there shall be added the following paragraph– 3 Notwithstanding that these Regulations were not made entirely under the Act, sections 107 to 109, section 110 except subsection (4), sections 111 to 116, section 118, section 119 and sections 121 to 127 of and Schedule 3 to the Act shall apply for the purposes of these Regulations as they apply for the purposes of the Act. . Amendment of heading to Schedule 2 to the Advertising Regulations 9 For the heading to Schedule 2 to the Advertising Regulations (particulars to be contained in advertisements to health professionals) there shall be substituted “ PARTICULARS TO BE CONTAINED IN ADVERTISEMENTS TO PERSONS QUALIFIED TO PRESCRIBE OR SUPPLY ”. Amendment of regulation 2 of the Monitoring of Advertising Regulations 10 In paragraph (1) of regulation 2 of the Monitoring of Advertising Regulations (interpretation and application) in the definition of “publication” after the words “the dissemination” there shall be inserted the words “or issue”. Amendment of regulation 3 of the Monitoring of Advertising Regulations 11 In paragraph (1) of regulation 3 of the Monitoring of Advertising Regulations (proceedings) before the words “Proceedings under” there shall be inserted the words “Subject to regulation 13 and the Schedule to these Regulations,”. Addition of regulations 12 and 13 to the Monitoring of Advertising Regulations 12 After regulation 11 of the Monitoring of Advertising Regulations (control by a complaints authority of certain broadcast advertisements) there shall be added the following regulations– Application of enforcement provisions of the 1968 Act 12 Notwithstanding that these Regulations were not made under the 1968 Act, sections 107 to 109, section 110 except subsection (4), sections 111 to 116, section 118, section 119 and sections 121 to 127 of and Schedule 3 to the 1968 Act shall apply for the purposes of the Regulations as they apply for the purposes of the 1968 Act. Scrutiny of certain published or proposed advertisements 13 The provisions of the Schedule to these Regulations (scrutiny of certain published or proposed advertisements) shall have effect. . Addition of a Schedule to the Monitoring of Advertising Regulations 13 At the end of the Monitoring of Advertising Regulations there shall be added the following Schedule– SCHEDULE SCRUTINY OF CERTAIN PUBLISHED OR PROPOSED ADVERTISEMENTS Regulation 13 Notices requiring copies of advertisements to be furnished to the Health Ministers 1 The Health Ministers may serve a notice in writing in respect of any relevant medicinal product or in respect of relevant medicinal products of any class or description on any person appearing to them to be concerned or likely to be concerned with the publication of an advertisement requiring that person– a to furnish to the Health Ministers within such period as may be specified in the notice a copy of any advertisement which he has published or proposes to publish; or b to furnish to the Health Ministers a copy of any advertisement which he proposes to publish and the notice shall specify– i the number of days before the proposed publication date by which the advertisement shall be furnished, and ii the period during which the requirement shall continue, such period not to exceed twelve months, and that notice may require that person to refrain from publishing any advertisement required to be furnished under sub-paragraph (a) or (b) during such period as may be specified in the notice unless that notice has been withdrawn by the Health Ministers. 2 Where the Health Ministers serve a notice on a person under paragraph 1, the notice shall state the Health Ministers' reasons for requiring that person to furnish the advertisement and for requiring him (if the notice does) to refrain from publishing it. “Minded to” notices in respect of determinations of breaches of the Advertising Regulations 3 If the Health Ministers, having considered an advertisement furnished to them in accordance with paragraphs 1(a) or 1(b) or otherwise obtained by them, are minded to make a determination that the advertisement, if published, would be in breach of the Advertising Regulations, they may serve a notice on any person appearing to them to be concerned or likely to be concerned with the publication of the advertisement stating– a that they are minded to make a determination that the advertisement, if published, would be in breach of the Advertising Regulations; b the reasons why they are minded to make that determination; c that if such a determination is made, that person may be required to refrain from publishing that advertisement by a notice served under paragraph 5; and d that the person on whom the notice is served has twenty-one days from the date of the notice in which to make written representations that the proposed determination should not be made, and the notice may require that person to refrain from publishing that advertisement until the notice has been withdrawn by the Health Ministers. Decisions that an advertisement would not be in breach 4 If, upon further consideration, in particular of any representations made to them under paragraph 3(d), the Health Ministers decide that the advertisement, if published, would not be in breach of the Advertising Regulations, they shall serve a notice on the person on whom they had previously served a notice under paragraph 3– a informing him of that decision; and b withdrawing the notice served in respect of that advertisement under paragraph 3. Determinations that an advertisement would be in breach 5 If, upon further consideration, in particular of any representations made to them under paragraph 3(d), the Health Ministers make a determination that the advertisement, if published, would be in breach of the Advertising Regulations, they shall serve a notice on the person on whom they had previously served a notice under paragraph 3– a stating the reasons for the determination; b withdrawing the notice served in respect of that advertisement under paragraph 3, and the notice may require him to refrain from publishing that advertisement. Publication of the determination and a corrective statement 6 Where the Health Ministers have prohibited the publication of an advertisement under paragraph 5 and that advertisement has previously been published, they may require any person against whom the prohibition has been imposed to publish within a specified time in such form as the Health Ministers consider appropriate– a the reasons for the determination (as notified to them by the Health Ministers under paragraph 5(a)), in full or in part (whichever the Health Ministers require); and b a corrective statement in relation to the advertisement in respect of which the prohibition has been imposed. Offences 7 Any person who fails to comply with any requirement imposed on him by a notice under paragraphs 1, 3 or 5 shall be guilty of an offence and shall be liable– a on summary conviction, to a fine not exceeding level 5 on the standard scale, b on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both. 8 Any person who fails to comply with any requirement imposed on him under paragraph 6 shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale. . Signed by authority of the Secretary of State for Health Hayman Parliamentary Under Secretary of State Department of Health 1st February 1999 Signed by authority of the Secretary of State for Wales Jon Owen Jones Parliamentary Under Secretary of State Welsh Office 5th February 1999 Signed by authority of the Secretary of State for Scotland Sam Galbraith Parliamentary Under Secretary of State Scottish Office 3rd February 1999 Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on D.C. Gowdy Permanent Secretary 4th February 1999.