What changed between the plenary report and the adopted text

Added:2. All the information contained in the documentation referred to in paragraph 1 shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of the medicinal product concerned.

Added:3. Quotations as well as tables and other illustrative matter taken from medical journals or other scientific works for use in the documentation referred to in paragraph 1 shall be faithfully reproduced and the precise sources indicated.

Added:Article 182 Obligations related to medical sales representatives

Added:1. Medical sales representatives shall be given adequate training by the undertaking that employs them and shall have sufficient scientific knowledge to be able to provide information that is precise and as complete as possible about the medicinal products that they promote. The information provided by medical sales representatives shall be in accordance with Article 176.

Added:2. During each visit, medical sales representatives shall give the persons visited, or have available for them, summaries of the product characteristics of each medicinal product they present together, if the legislation of the Member State so permits, with details of the price and conditions for reimbursement referred to in Article 180(1), second subparagraph.

Added:3. Medical sales representatives shall transmit to the scientific service referred to in Article 187(1) any information about the use of the medicinal products they advertise, with particular reference to any adverse reactions reported to them by the persons they visit.

Added:Article 183 Promotion of medicinal products

Added:1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy. [Am. 295]

Added:2. Hospitality at sales promotion events shall always be strictly limited to their main purpose and must not be extended to persons other than persons qualified to prescribe or supply medicinal products.

Added:3. Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under paragraph 1 or contrary to paragraph 2.

Added:4. Existing measures or trade practices in Member States relating to prices, margins and discounts shall not be affected by the rules set out in paragraphs 1, 2 and 3.

Added:Article 184 Hospitality at scientific events

Added:The provisions of Article 183(1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes. Such hospitality shall always be strictly limited to the main scientific objective of the event. It must not be extended to persons other than persons qualified to prescribe or supply medicinal products.

Added:Article 185 Provision of samples of medicinal products

Added:1. Free samples of medicinal products shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions:

Added:(a) the number of samples for each medicinal product each year on prescription shall be limited;

Added:(b) any supply of samples shall be in response to a written request, signed and dated, from the persons qualified to prescribe or supply medicinal products;

Added:(c) the persons qualified to supply samples shall maintain an adequate system of control and accountability;

Added:(d) each sample shall be no larger than the smallest presentation on the market;

Added:(e) each sample shall be marked ‘free medical sample — not for sale’ or shall show some other wording having the same meaning;

Added:(f) each sample shall be accompanied by a copy of the summary of product characteristics;

Added:(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied. [Am. 296]

Added:2. On an exceptional basis, free samples of medicinal products not subject to medical prescription may also be provided to persons qualified to supply them, subject to the conditions of paragraph 1.

Added:3. Member States may also place further restrictions on the distribution of samples of certain medicinal products.

Added:Article 186 Implementation of advertising provisions by the Member States

Added:1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. At least for advertisements targeted at the general public, such methods, which may shall be based on a system of prior vetting, and shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings. [Am. 297]

Added:2. Under the legal provisions referred to in paragraph 1, Member States shall confer upon the courts or competent authorities of the Member States powers enabling them, in cases where they deem such measures to be necessary, taking into account all the interests involved, and in particular the public interest:

Added:(a) to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising; or

Added:(b) if misleading advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication.

Added:Member States shall confer upon the courts or competent authorities of the Member States the powers referred to in the first subparagraph, points (a) and (b), even without proof of actual loss or damage or of intention or negligence on the part of the advertiser.

Added:3. Member States shall make provision for the measures referred to in paragraph 2 to be taken under an accelerated procedure, either with interim effect or with definitive effect.

Added:It shall be for each Member State to decide which of the two options set out in the first subparagraph to select.

Added:4. Member States may confer upon the courts or competent authorities of the Member States powers enabling them, with a view to eliminating the continuing effects of misleading advertising the cessation of which has been ordered by a final decision:

Added:(a) to require publication of that decision in full or in part and in such form as they deem adequate;

Added:(b) to require in addition the publication of a corrective statement.

Added:4a. Member States shall set up and maintain a national transparency register of transfers of value regarding the advertising activities referred to in Articles 175, 177, 180 and 182 to 185, targeting persons qualified to prescribe medicinal products. The Commission shall publish on its website a list referring to all national registries. [Am. 298]

Added:4b. The national registries referred to in paragraph 4a of this Article shall include at least the following information:

Added:(a) the name of the marketing authorisation holder;

Added:(b) the name of a person qualified to prescribe medicinal products;

Added:(c) the medicinal product concerned;

Added:(d) the type of advertising activity, referred to in Article 175(1), second subparagraph, points (b) to (g) and Article 184;

Added:(e) the monetary value. [Am. 299]

Added:4c. Marketing authorisation holders shall use the national transparency register referred to in paragraph 4a to submit the information referred to in paragraph 4b in relation to each person qualified to prescribe medicinal products in the Member State where such activity takes place. [Am. 300]

Added:5. The Paragraphs 1 to 4 4c shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings referred to in paragraph 1. [Am. 301]

Added:Article 187 Implementation of advertising provisions by the marketing authorisation holder

Added:1. The marketing authorisation holders shall establish, within their undertaking or not-for-profit entities, a scientific service in charge of information about the medicinal products that they place on the market.

Added:2. The marketing authorisation holder shall:

Added:(a) keep available for, or communicate to, the competent authorities of the Member States or bodies responsible for monitoring advertising of medicinal products, a sample of all advertisements emanating from its undertaking or not-for-profit entities together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination;

Added:(b) ensure that advertising of medicinal products by their undertaking or not-for-profit entities conforms to the requirements of this Chapter;

Added:(c) verify that medical sales representatives employed by their undertaking or not-for-profit entities have been adequately trained and fulfil the obligations imposed upon them by Article 182, paragraphs 2 and 3;

Added:(d) supply the competent authorities of the Member States or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities;

Added:(da) report activities in national registries, as laid down in Article 186(4c); [Am. 302]

Added:(e) ensure that the decisions taken by the competent authorities of the Member States or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with.

Added:3. The Member States shall not prohibit the co-promotion of a medicinal product by the marketing authorisation holders and one or more companies nominated by them.

Added:Chapter XIV Supervision and controls

Added:Section 1 Supervision

Added:Article 188 System of supervision and inspections

Added:1. The competent authority of the Member State concerned shall, in cooperation with the Agency and where relevant, other Member States, ensure compliance with the rules of this Directive, namely the principles of good manufacturing practice and good distribution practices referred to in Articles 160 and 161.

Added:For the purposes of the first subparagraph, the competent authority of the Member State shall have in place a system of supervision that shall include the following measures:

Added:(a) announced and, where appropriate, unannounced on-site inspections;