What changed between the plenary report and the adopted text

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

Added:(d) the supply of samples of medicinal products;

Added:(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, except when their intrinsic value is minimal; [Am. 285]

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

Added:(g) 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;

Added:(h) advertising related to medicinal products, that does not refer to specific medicinal products.

Added:2. The following are not covered by this Chapter:

Added:(a) the labelling and package leaflets, which are subject to the provisions of Chapter VI;

Added:(b) correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;

Added:(c) factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims;

Added:(d) information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products.

Added:Article 176 General provisions on advertising of medicinal products

Added:1. Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorisation has not been granted.

Added:2. All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.

Added:3. The advertising of a medicinal product:

Added:(a) shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties;

Added:(b) shall be accurate, verifiable and not be misleading.

Added:(ba) shall not induce to an excessive or abusive use of the medicinal product. [Am. 286]

Added:4. Any form of advertising that aims to highlight negatively another medicinal product shall be prohibited. Advertising that suggests that a medicinal product is safer or more effective than another medicinal product shall also be prohibited, unless demonstrated and supported by the summary of product characteristics for the relevant indications and patient population. [Am. 287]

Added:Article 177 Restrictions on advertising of medicinal products

Added:1. Member States shall prohibit the advertising to the general public of medicinal products that:

Added:(a) are available on medical prescription only, in accordance with Chapter IV;

Added:(b) contain substances classified as psychotropic or narcotic within the meaning of international conventions.

Added:(ba) are antibiotics or antimicrobials for which there is an identified risk of antimicrobial resistance as referred to in Article 51(1a). [Am. 288]

Added:2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a medical practitionerhealthcare professional for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary. [Am. 289]

Added:3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.

Added:4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States. [Am. 290]

Added:5. The prohibition referred to in paragraph 1 shall apply without prejudice to Article 21 of Directive 2010/13/EU.

Added:6. Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes.

Added:Article 178 Advertising to the general public

Added:1. Without prejudice to Article 177, all advertising to the general public of a medicinal product shall:

Added:(a) be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a medicinal product;

Added:(b) include the following minimum information:

Added:(i) the name of the medicinal product, as well as the common name if the medicinal product contains only one active substance;

Added:(ii) the information necessary for correct use and disposal of the medicinal product; [Am. 291]

Added:(iii) an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be, and to consult a medical practitioner or a pharmacist for additional information. [Am. 292]

Added:2. Member States may decide that the advertising of a medicinal product to the general public may, notwithstanding paragraph 1, include only the name of the medicinal product or its active substance, or the trademark if it is intended solely as a reminder.

Added:2a. The Commission shall adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying requirements in relation to direct and indirect advertising of medicinal products through social media and other media platforms and product placements by celebrities and influencers. [Am. 293]

Added:Article 179 Restrictions on advertising to the general public

Added:1. The advertising of a medicinal product to the general public shall not contain any material that:

Added:(a) gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;

Added:(b) suggests that the effects of taking the medicinal product are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product;

Added:(c) suggests that the health of the subject can be enhanced by taking the medicinal product;

Added:(d) suggests that the health of the subject could be affected by not taking the medicinal product;

Added:(e) is directed exclusively or principally at children;

Added:(f) refers to a recommendation by scientists, healthcare professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;

Added:(g) suggests that the medicinal product is a food, cosmetic or other consumer product;

Added:(h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural or not chemical; [Am. 294]

Added:(i) could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;

Added:(j) refers, in improper, alarming or misleading terms, to claims of recovery;

Added:(k) uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof.

Added:2. The prohibition set out in the paragraph 1, point (d), shall not apply to the vaccination campaigns referred to in Article 177(4).

Added:Article 180 Advertising to persons qualified to prescribe, administer or supply medicinal products

Added:1. Any advertising of a medicinal product to persons qualified to prescribe, administer or supply such products shall include:

Added:(a) essential information compatible with the summary of product characteristics;

Added:(b) the supply prescription status of the medicinal product.

Added:Member States may also require such advertising to include the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies.

Added:2. Member States may decide that the advertising of a medicinal product to persons qualified to prescribe, administer or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, or its international non-proprietary name, where this exists, or the trademark, if it is intended solely as a reminder.

Added:Article 181 Supporting documentation for advertising to persons qualified to prescribe, administer or supply medicinal products

Added:1. Any documentation relating to a medicinal product that is transmitted as part of the promotion of that medicinal product to persons qualified to prescribe, administer or supply it shall include, as a minimum, the particulars listed in Article 180(1) and shall state the date on which it was drawn up or last revised.