What changed between the plenary report and the adopted text

Added:(d) the name and address of the supplier of the medicinal product and consignee;

Added:(e) the batch number of the medicinal products at least for products bearing the safety features referred to in Article 67.

Added:2. Member States shall take all appropriate measures to ensure that persons authorised or entitled to supply medicinal products to the public are able to provide information that makes it possible to trace the distribution path of every medicinal product.

Added:Article 169 National requirements on wholesale distribution

Added:The provisions of this Chapter shall not prevent the application of more stringent requirements laid down by Member States in respect of the wholesale distribution of:

Added:(a) narcotic or psychotropic substances;

Added:(b) medicinal products derived from blood;

Added:(c) immunological medicinal products; and

Added:(d) radiopharmaceuticals.

Added:Article 170 Wholesale distribution to third countries

Added:In the case of wholesale distribution of medicinal products to third countries, Articles 162 and 166(1), point (c), shall not apply.

Added:Where wholesale distributors supply medicinal products to persons in third countries, they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned.

Added:Article 168 shall apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public.

Added:Article 171 Brokering medicinal products

Added:1. Persons brokering medicinal products shall ensure that the brokered medicinal products are covered by a valid marketing authorisation.

Added:Persons brokering medicinal products shall have a permanent address and contact details in the Union, so as to ensure accurate identification, location, communication and supervision of their activities by competent authorities of the Member States.

Added:The requirements set out in Article 166(1), points (e) to (j), shall apply mutatis mutandis to the brokering of medicinal products.

Added:2. Persons may only broker medicinal products if they are registered with the competent authority of the Member State where they have their permanent address referred to in paragraph 1, second subparagraph. Those persons shall submit, by electronic means, at least, their name, corporate name and permanent address to the competent authority in order to register. They shall notify, by electronic means, the competent authority of the Member State of any changes thereof without delay.

Added:The competent authority of the Member State shall enter the information referred to in the first subparagraph in a register that shall be publicly available.

Added:3. The principles referred to in Article 160 shall include specific provisions for brokering.

Added:4. Inspections referred to in Article 188 shall be carried out under the responsibility of the Member State where the person brokering medicinal products is registered.

Added:If a person brokering medicinal products does not comply with the requirements set out in this Article, the competent authority of the Member State may decide to remove that person from the register referred to in paragraph 2. In such event, the competent authority of the Member State shall notify that person thereof.

Added:Section 2 Sale at a distance to the public

Added:Article 172 General requirements for sale at distance

Added:1. Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance to the public by means of services as defined in Directive (EU) 2015/1535 of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services under the following conditions:

Added:(a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established and complies, where applicable, with the conditions referred to in paragraph 2 of this Article; [Am. 284]

Added:(b) the person referred to in point (a) has notified the Member State in which that person is established of at least the following information:

Added:(i) name or corporate name and permanent address of the place of activity from where those medicinal products are supplied;

Added:(ii) the starting date of the activity of offering medicinal products for sale at a distance to the public by means of information society services;

Added:(iii) the address of the website used for that purpose and all relevant information necessary to identify that website;

Added:(iv) if applicable, the prescription status in accordance with Chapter IV of the medicinal products offered for sale at a distance to the public by means of information society services.

Added:Where appropriate, that information shall be updated;

Added:(c) the medicinal products comply with the national legislation of the Member State of destination in accordance with Article 5(1);

Added:(d) without prejudice to the information requirements set out in Directive 2000/31/EC of the European Parliament and of the Council, the website offering the medicinal products contains at least:

Added:(i) the contact details of the competent authority of the Member State or the authority notified pursuant to point (b);

Added:(ii) a hyperlink to the website referred to in Article 174 of the Member State of establishment;

Added:(iii) the common logo referred to in Article 173 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of medicinal products. The common logo shall contain a hyperlink to the entry of the person in the list referred to in Article 174(1), point (c).

Added:2. Member States may impose conditions, justified on grounds of public health protection, for the retail supply on their territory of medicinal products for sale at a distance to the public by means of information society services.

Added:3. Without prejudice to Directive 2000/31/EC and the requirements set out in this Section, Member States shall take the necessary measures to ensure that other persons than those referred to in paragraph 1 that offer medicinal products for sale at a distance to the public by means of information society services and that operate on their territory are subject to effective, proportionate and dissuasive penalties.

Added:Article 173 Requirements for common logo

Added:1. A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering medicinal products for sale at a distance to the public is established. That logo shall be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with Article 172(1), point (d).

Added:2. In order to harmonise the functioning of the common logo, the Commission shall adopt implementing acts regarding:

Added:(a) the technical, electronic and cryptographic requirements for verification of the authenticity of the common logo;

Added:(b) the design of the common logo.

Added:Those implementing acts shall, where necessary, be amended to take account of technical and scientific progress. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 214(2).

Added:Article 174 Information about the supply at distance to the public

Added:1. Each Member State shall set up a website providing at least the following:

Added:(a) information on the national legislation applicable to the offering of medicinal products for sale at a distance to the public by means of information society services, including information on the fact that there may be differences between Member States regarding classification of medicinal products and the conditions for their supply;

Added:(b) information on the purpose of the common logo;

Added:(c) the list of persons offering the medicinal products for sale at a distance to the public by means of information society services in accordance with Article 172 as well as their website addresses;

Added:(d) background information on the risks related to medicinal products supplied illegally to the public by means of information society services.

Added:This website shall contain a hyperlink to the website referred to in paragraph 2.

Added:2. The Agency shall set up a website providing the information referred to in paragraph 1, first subparagraph, points (b) and (d), information on the Union law applicable to falsified medicinal products as well as hyperlinks to the websites of the Member States referred to in paragraph 1. The Agency’s website shall explicitly mention that the Member States’ websites contain information on persons authorised or entitled to supply medicinal products by sales at a distance in the Member State concerned.

Added:3. The Commission shall, in cooperation with the competent authorities, conduct or promote information campaigns aimed at the general public on the dangers of falsified medicinal products. Those campaigns shall raise consumer awareness of the risks related to medicinal products supplied illegally by sales at a distance as well as of the functioning of the common logo and the websites referred to in paragraphs 1 and 2.

Added:Chapter XIII Advertising

Added:Article 175 Definition of advertising of medicinal products

Added:1. For the purposes of this Chapter, ‘advertising of medicinal products’ shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.

Added:It shall include in particular:

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

Added:(b) advertising of medicinal products to persons qualified to prescribe, administer or supply them;