Medicinal Products (Control of Advertising) Regulations, 2007

• Jurisdiction: Ireland
• Citation: IR SI 541/2007

S.I. No. 541 of 2007

MEDICINAL PRODUCTS (CONTROL OF ADVERTISING) REGULATIONS 2007

ARRANGEMENT OF REGULATIONS

PART 1

GENERAL

1. Citation

2. Commencement

3. Revocations

4. Interpretation

5. Exemptions

PART 2

ADVERTISING GENERALLY

6. Prohibition on the advertisement of medicinal products that are not the subject of a marketing authorisation or certificate of traditional-use registration

7. Requirements as to the accuracy of advertisements

PART 3

ADVERTISING TO THE PUBLIC

8. Scope of Part 3 of Regulations

9. Prohibition on the advertisement of prescription-only medicinal products

10. Prohibition on the advertisement of certain other medicinal products

11. Prohibition of certain material in advertisements

12. Form and content of advertisements

13. Exception for approved vaccination campaign

14. Prohibition of supply of medicinal products to the public for promotional purposes

PART 4

ADVERTISING TO PERSONS QUALIFIED TO PRESCRIBE OR SUPPLY

15. Scope of Part 4 of Regulations

16. Restrictions on advertisements to persons qualified to prescribe or supply

17. Advertisements intended only as a reminder

18. Exemption for promotional aids

19. Written material accompanying promotions

20. Medical sales representatives

21. Inducements and hospitality

22. Free samples

23. Compendium of summaries of product characteristics

PART 5

DUTIES OF HOLDERS OF MARKETING AUTHORISATIONS CERTIFICATES OF REGISTRATION AND CERTIFICATES OF TRADITIONAL-USE REGISTRATION

24. Duties

PART 6

MONITORING AND SELF-REGULATION

25. Requirement for corrective advertising

26. Approval of voluntary codes of advertising practice

SCHEDULE

Particulars that may be contained in advertisements for Registered Homeopathic Medicinal products

S.I. No. 541 of 2007

MEDICINAL PRODUCTS (CONTROL OF ADVERTISING) REGULATIONS 2007

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 31st July, 2007.

The Minister for Health and Children, in exercise of the powers conferred on her by section 32 of the Irish Medicines Board Act 1995 (No. 29 of 1995), as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006) and as adapted by the Health (Alteration of Name of Department and Title of Minister) Order 1997 ( S.I. No. 308 of 1997 ) and for the purpose of giving full effect to Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC), hereby make the following regulations—

PART 1 GENERAL

Citation.

1. These Regulations may be cited as the Medicinal Products (Control of Advertising) Regulations 2007.

Commencement.

2. These Regulations shall come into operation on 23rd July 2007.

Revocations.

3. The Medical Preparations (Advertisement and Sale) Regulations 1958 ( S.I. No. 135 of 1958 ), the Medical Preparations (Advertising) Regulations 1993 ( S.I. No. 76 of 1993 ) and the Medical Preparations (Advertising) (Amendment) Regulations 1996 ( S.I. No. 308 of 1996 ) are hereby revoked.

Interpretation.

4. (1) In these Regulations—

‘2001 Directive’ means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use 1 as amended by—

(a) Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components 2 ,

(b) Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use 3 ,

(c) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use 4 , and

(d) Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use 5 ;

‘advertising’, in relation to a medicinal product, includes any form of door to door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products and including in particular—

(a) the advertising of medicinal products to the general public;

(b) the advertising of medicinal products to persons qualified to prescribe or supply them;

(c) visits by medical sales representatives to persons qualified to prescribe medicinal products;

(d) the supply of samples of medicinal products;

(e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind;

(f) the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; and

(g) the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith;

and cognate words shall be construed accordingly;

‘Board’ means the Irish Medicines Board established by section 3 of the Irish Medicines Board Act 1995 ;

‘certificate of registration’ means a certificate of registration which is for the time being in force and which has been granted by the Board under the Medicinal Product (Control of Placing on the Market) Regulations 2007 in respect of a homeopathic medicinal product;

‘certificate of traditional-use registration’ means a certificate of traditional-use registration which is for the time being in force and which has been granted by the Board under the Medicinal Products (Control of Placing on the Market) Regulations 2007 in respect of a traditional herbal medicinal product;

‘common name’ in relation to a medicinal product means the international non-proprietary name, or, if one does not exist, the usual common name;

‘EEA Agreement’ means the Agreement on the European Economic Area signed in Oporto on 2 May 1992 as adjusted by the Protocol to that Agreement done at Brussels on17 March 1993 6 ;

‘EEA State’ means a State which is a contracting party to the EEA Agreement;

‘health professional’ means a person of any of the following classes—

(i) registered medical practitioners,

(ii) registered dentists,

(iii) registered pharmacists,

(iv) registered nurses;

‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;

‘homeopathic medicinal product’ means any medicinal product, which may contain a number of principles, prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in an EEA State. The term also includes anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method;

‘international non-proprietary name’ in relation to a medicinal product means the international non-proprietary name recommended by the World Health Organisation;

‘marketing authorisation’ means an authorisation which is for the time being in force and which has been granted by the Board in accordance with the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ) and includes a product authorisation, a parallel import licence, an authorisation granted by the Commission under Regulation (EEC) No. 2309/93 7 or Regulation (EC) No 726/2004 8 and an authorisation granted by the Board in accordance with Article 126a of the 2001 Directive;

‘Minister’ means the Minister for Health and Children;

'misleading advertising' means any advertising which in any way, including its presentation, deceives or is likely to deceive the persons to whom it is addressed or whom it reaches and which, by reason of its deceptive nature, is likely to affect their economic behaviour or which, for those reasons, injures or is likely to injure a competitor;

‘name’ in relation to a medicinal product, means the name given to the product which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder;

‘parallel import licence’ means a marketing authorisation, or a certificate of traditional-use registration, which is for the time being in force and which has been granted by the Board under the Medicinal Products (Control of Placing on the Market) Regulations 2007 in respect of a medicinal product which is imported into the State from another EEA state in accordance with the rules of Community law relating to parallel imports;

‘product authorisation’ means an authorisation which is for the time being in force and which has been granted in pursuance of the Medicinal Products (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 );

‘promotional aid’ means a non-monetary gift, that is inexpensive, relevant to the practice of medicine or pharmacy, and is made for a promotional purpose by a commercially interested party;

‘registered dentist’ means a person registered in the register established under the Dentists Act 1985 (No. 9 of 1985);

‘registered homeopathic medicinal product’ means a homeopathic medicinal product which is the subject of a certificate of registration;

‘registered medical practitioner’ means a person registered in the register established under the Medical Practitioners Act 1978 (No. 4 of 1978);

‘registered nurse’ means a person registered in the register of nurses maintained by An Bord Altranais under section 27 of the Nurses Act 1985 (No...