IE
S.I. No. 541/2007 - Medicinal Products (Control of Advertising) Regulations 2007
Table of Provisions (27)
Statutory Text (27 Articles)
1. The clear mention of the words “
homeopathic medicinal product
”.
2. The scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in relation to the homeopathic manufacturing procedure described for that stock or stocks and, where the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks may be supplemented by an invented name.
3. The name and address of the holder of the certificate of registration and, where different, the name and address of the manufacturer.
4. The method of administration and, if necessary, the route.
5. The expiry date of the product in clear terms, stating the month and year.
6. The pharmaceutical form.
7. The contents of the sales presentation.
8. Any special storage precautions.
9. Any special warning necessary for the product concerned.
10. The manufacturer’s batch number.
11. The registration number allocated by the Board preceded by the letters
“HoR”.
12. The words “homeopathic medicinal product without approved therapeutic
indications”.
13. A warning advising the user to consult a doctor if the symptoms persist.
GIVEN under the Official Seal,
20 July 2007
MARY HARNEY.
Minister for Health and Children.
EXPLANATORY NOTE.
(This note is not part of the Instrument and does not purport to be a legal interpretation).
The main purpose of these Regulations is to implement TITLES VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC) relating to the advertising of medicinal products for human use. They cover advertising both to health professionals and to the general public.
1 OJ No. L. 311, 28.11.2001, p.67.
2 OJ No. L. 33, 8.02.2003, p.30.
3 OJ No. L. 159, 27.06.2003, p.46.
4 OJ No. L. 136, 30.4.2004, p.85.
5 OJ No. L. 136, 30.4.2004, p.34.
6 OJ No. L 1, 3.01.1994, p.572.
7 OJ No. L.214, 24.8.1993, p.1
8 OJ L 136, 30.4.2004, p. 1.
14. (1) A person to which this Regulation applies shall not sell or supply for promotional purposes any medicinal product to any member of the general public.
(2) The persons to which this Regulation applies are—
(
a
) a person being the holder of a marketing authorisation, a certificate of registration or a certificate of traditional-use registration, or a person acting on behalf of any such person; and
(
b
) a person who in the course of his or her business manufactures medicinal products, or who sells medicinal products by wholesale, whether or not any such activities form a significant part of his or her business, or a person acting on behalf of any such person.
PART 4 ADVERTISING TO PERSONS QUALIFIED TO PRESCRIBE OR SUPPLY
Scope of Part 4 of Regulations.
15. The provisions of this Part of the Regulations apply only to advertisements that are directed wholly or mainly at persons qualified to prescribe or supply medicinal products and accordingly any references in this Part to advertisements are references to advertisements to which this Part applies.
Restrictions on advertisements to persons qualified to prescribe or supply.
16. (1) Subject to Regulations 17 and 18, a person shall not issue an advertisement relating to a medicinal product unless such advertisement contains—
(
a
) essential information compatible with the summary of product characteristics;
(
b
) the name of the product, and a list of the active ingredients using the common name placed immediately adjacent to the most prominent display of the name of the product;
(
c
) the classification for the sale or supply of the product;
(
d
) one or more of the indications for the use of the product compatible with the terms of the marketing authorisation, or certificate of traditional-use registration;
(
e
) a clear statement of the entries in the summary of product characteristics relating to adverse reactions, precautions and relevant contra-indications;
(
f
) a clear statement of the entries in the summary of product characteristics relating to the dosage and method of use relevant to the indications shown. The method of administration should be shown where this is not obvious;
(
g
) the name and address of the holder of the marketing authorisation, certificate of registration or certificate of traditional-use registration or the business name and address of the part of the business responsible for placing the medicinal product on the market;
(
h
) the marketing authorisation, certificate of registration or certificate of traditional-use registration number of the medicinal product; and
(
i
) if it is a traditional herbal medicinal product, the following words “Traditional herbal medicinal product for use in” followed by a statement of one or more therapeutic indications for the product compatible with the terms of the certificate of traditional-use registration for that product, followed by the words “exclusively based upon long-standing use.”.
(2) The information contained in subparagraphs (
e
) and (
f
) of paragraph (1) shall be printed in a clear and legible manner and be placed in such a position in the advertisement that their relationship to the claims and indications for the product can readily be appreciated by the reader.
Advertisements intended only as a reminder.
17. Subject to Regulation 18, a person shall not in respect of a medicinal product issue an abbreviated advertisement that is intended solely as a reminder, unless such advertisement contains—
(
a
) essential information compatible with the summary of product characteristics;
(
b
) the name of the product, or its international non-proprietary name, where such exists, or the trademark;
(
c
) the classification for the sale or supply of the medicinal product;
(
d
) the name and address of the holder of the marketing authorisation, certificate of registration or certificate of traditional-use registration or the business name and address of the part of the business responsible for placing the medicinal product on the market;
(
e
) a statement which clearly indicates that further information is available on request to the holder of the authorisation or certificate, or in the summary of product characteristics relating to the product; and
(
f
) if it is a traditional herbal medicinal product, the following words “Traditional herbal medicinal product for use in” followed by a statement of one or more therapeutic indications for the product compatible with the terms of the certificate of traditional-use registration for that product, followed by the words “exclusively based upon long-standing use.”.
Exemption for promotional aids.
18. The provisions of Regulations 16, and 17 shall not apply to an advertisement relating to a medicinal product which is on a promotional aid if–
(
a
) the advertisement consists solely of the name of the product or its international non-proprietary name, where such exists, or the trademark (or in the case of a homeopathic medicinal product that is the subject of a certificate of registration, the scientific name of the stock or stocks or its invented name);
(
b
) the advertisement is intended solely as a reminder; and
(
c
) the promotional aid is intended for supply only to persons qualified to prescribe or supply medicinal products.
Written material accompanying promotions.
19. (1) A person shall not send or deliver to persons qualified to prescribe or supply medicinal products as part of a promotion of a medicinal product any written material relating to that product unless it includes as a minimum—
(
a
) essential information compatible with the summary of product characteristics;
(
b
) the classification for the sale or supply of the medicinal product; and
(
c
) a statement showing the date on which the document was drawn up or last revised.
(2) A person shall not include any information in written material to which paragraph (1) applies which is not accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product to which the material relates.
(3) A person shall not include in written material to which paragraph (1) applies any quotation, tables or other illustrative matter taken from a medical journal or other scientific work unless it is accurately reproduced and the precise sources of the information are indicated.
Medical sales representatives.
20. (1) Subject to Regulation 23, a medical sales representative who promotes medicinal products to persons qualified to prescribe or supply such products shall, during each visit, give to all such persons that he or she visits, or have available for them, a copy of the summary of product characteristics for each such product that he or she promotes.
(2) A medical sales representative shall, in relation to any medicinal product that he or she promotes, forthwith report, to the scientific service established in accordance with Regulation 24, any information about the use of such products, with particular reference to any adverse reactions reported by such persons in the course of such visits.
Inducements and hospitality.
21. (1) A person shall not, in the course of promoting medicinal products to persons qualified to prescribe or supply such products, supply, offer or promise to such persons any gift, pecuniary advantage or benefit in kind, unless it is inexpensive and relevant to the practice of medicine or pharmacy.
(2) Notwithstanding the provisions of paragraph (1), a person may offer hospitality at sales promotion events or at other events for purely professional and scientific purposes, provided such hospitality—
(
a
) is reasonable in level,
(
b
) is strictly limited to the main purpose or scientific objective of the event, and
(
c
) is not extended to persons other than health professionals.
(3) A person qualified to prescribe or supply medicinal products shall not solicit or accept any gift, pecuniary advantage, benefit in kind, hospitality, sponsorship, or any other inducement, where the provision of such is prohibited by paragraphs (1) and (2) of this Regulation.
(4) The provisions of this Regulation shall not prejudice the negotiation of prices, margins and discounts in the ordinary course of business provided such prices, margins and discounts are incorporated in the sales invoice as a consequence of such negotiation.
Free samples.
22. (1) A person shall not supply a free sample of a medicinal product to any person unless that person is qualified to prescribe such product, and in such case only where the following conditions are satisfied—
(
a
) such sample is provided on an exceptional basis only and for the purpose of acquiring experience in dealing with such a product;
(
b
) the number of such samples of each product that may be supplied to any one recipient in any one year shall be limited and in any case shall not exceed six in number;
(
c
) the supply of any such sample is made only in response to a written request, signed and dated, by the recipient;
(
d
) the supplier of such samples maintains an adequate system of control and accountability;
(
e
) each such sample is no larger than the smallest presentation of the product on the market;
(
f
) each such sample is marked "free medical sample — not for sale" or words to the like effect; and
(
g
) each such sample is accompanied by a copy of the summary of product characteristics for each such product.
(2) A person shall not supply a sample of a medicinal product which is a controlled drug under
section 2
of the
Misuse of Drugs Act 1977
or which is an antidepressant, hypnotic, sedative or tranquilliser.
Compendium of summaries of product characteristics.
23. (1) Subject to paragraphs (2) and (3), the provisions of Regulations 20(1) and 24(1)(
c
) shall not apply in respect of a medicinal product if—
(
a
) the summary of product characteristics in respect of such product has been included in a compendium or other such reference publication which has been delivered within the previous twelve months to the class of health professional visited by the medical sales representatives in the advertising or promotion of such product; and
(
b
) the summary of product characteristics for such product has not been amended from that included in the aforementioned compendium or other such reference publication.
(2) This Regulation shall not apply to a medicinal product that has been placed on the market in the State for the first time during the period of twelve months after the date of the most recent publication of the compendium or other such publication referred to in paragraph (1).
(3) In this Regulation the expression “compendium or other such publication” shall include any electronic version of any such publication that is freely accessible by health professionals.
PART 5 DUTIES OF HOLDERS OF MARKETING AUTHORISATIONS, CERTIFICATES OF REGISTRATION AND CERTIFICATES OF TRADITIONAL-USE REGISTRATION
Duties.
24. (1) The holder of a marketing authorisation, certificate of registration or certificate of traditional-use registration, in respect of a medicinal product he or she has placed on the market, shall—
(
a
) establish, within his undertaking, a scientific service to compile and collate all information, whether received from medical sales representatives employed by him or her or from any other source, relating to that product;
(
b
) ensure that, in relation to any such medicinal product which medical sales representatives promote, those medical sales representatives are given adequate training and have sufficient scientific knowledge to enable them to provide information which is as precise and as complete as possible about that product;
(
c
) subject to Regulation 23, ensure that any medical sales representative employed by him or her has available summaries of product characteristics for each medicinal product that he or she presents to health professionals and which may be supplied to such persons during visits;
(
d
) ensure that any such medical sales representative transmits to the scientific service such information about the use of the medicinal products that he or she advertises, with particular reference to any adverse reactions reported to such representative by the persons he or she visits;
(
e
) keep available a sample of all advertising emanating from his or her undertaking together with information indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination;
(
f
) whenever requested by an officer of the Board, furnish particulars of any advertisement or proposed advertisement for which he or she is responsible relating to that product, including the samples, information and particulars referred to in sub-paragraph (
d
);
(
g
) ensure that, in relation to an advertisement relating to that medicinal product, any decision taken by the Board is immediately and fully complied with; and
(
h
) ensure that any advertising of medicinal products carried out by or on behalf of his or her undertaking conforms with the requirements of these Regulations.
(2) Where in the opinion of the Board the requirements in relation to the training and scientific knowledge referred to in paragraph (1)(
b
) are not being observed, the Board may specify the training and scientific knowledge so required.
PART 6 MONITORING AND SELF-REGULATION
Requirement for corrective advertising.
25. (1) A person who—
(
a
) has issued or displayed or caused to be issued or displayed, or
(
b
) proposes to issue or display or causes to be issued or displayed,
any advertisement which in the opinion of the Board is misleading shall, if so directed by the Board, ensure that such advertisement or proposed advertisement is withdrawn and he or she shall in the case of an advertisement which has been issued or displayed, if further directed by the Board, publish a corrective statement in a form and by a means acceptable to the Board.
(2) A person who has been convicted of an offence under
section 32
of the
Irish Medicines Board Act 1995
in relation to these Regulations, where the Court was satisfied that an advertisement was misleading, shall if so directed by the Court withdraw the advertisement and, if required by the Court, publish a corrective statement in a form and by a means acceptable to the Court.
(3) Any direction given under paragraph (1) shall state in detail the reasons on which it is based.
Approval of voluntary codes of advertising practice.
26. (1) The Minister may, for the purpose of facilitating the voluntary control of the advertising of medicinal products by self regulatory bodies, approve of any code of practice or any part of any code of practice for the purpose of providing practical guidance with respect to the requirements or prohibitions of any of the provisions of these Regulations, and he or she may withdraw any such approval.
(2) Where the Minister approves or withdraws approval as provided for in paragraph (1), he or she shall publish a notice to that effect in Iris Oifigiúil.
(3) The operation of any code of practice that may be approved under this Regulation shall be without prejudice to the provisions of sections 32A to 32F of the Act relating to enforcement of the provisions of these regulations by authorised officers.
(Regulation 12(2)).
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
ARRANGEMENT OF REGULATIONS
PART 1
GENERAL