Text proposed by the Commission Amendment

Retail of veterinary medicinal products at a distance Retail of veterinary medicinal products at a distance

1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council (28) to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State. 1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products, with the exception of antimicrobials, psychotropic and biological or immunological veterinary medicinal products, on the internet to natural or legal persons established in the Union under the condition that:

(a) the veterinary medicinal products and the prescriptions comply with the law of the destination Member State;

(b) the natural or legal person offering veterinary medicinal products is permitted or qualified to supply prescription and non-prescription veterinary medicinal products to the public, including at a distance, in accordance with the national law of the Member State in which that person is established;

(c) the person referred to in point (a) has notified at least the following information to the Member State of establishment:

(i) the name or corporate name and the permanent address of the place of business from where the veterinary medicinal products are supplied;

(ii) the date on which veterinary medicinal products were first offered for sale at a distance to the public on the internet;

(iii) the address of the website used for that purpose and all information necessary to identify that website.

1a. On grounds of public or animal health, animal welfare or environmental protection, Members States shall be able to limit or condition, or both, the sale at a distance on the internet to the public on their territory of veterinary medicinal products or of other prescription veterinary medicinal products for food producing animals.

2. In addition to the information requirements set out in Article 6 of the Directive 2000/31/EC of the European Parliament and of the Council (29), websites offering veterinary medicinal products shall contain at least: 2. In addition to the information requirements set out in Article 6 of the Directive 2000/31/EC of the European Parliament and of the Council (29) and Article 6 of Directive 2011/83/EU of the European Parliament and of the Council (29a), websites offering veterinary medicinal products shall contain at least:

(a) the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established; (a) the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established;

(b) a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5; (b) a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5;

(c) the common logo established in accordance with paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of veterinary medicinal products and containing a hyperlink to the entry of the retailer in the list of authorised retailers referred to in point (c) of paragraph 5. (c) the common logo established in accordance with paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of veterinary medicinal products and containing a hyperlink to the entry of the retailer in the list of authorised retailers referred to in point (c) of paragraph 5.

3. A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering veterinary medicinal products for sale at a distance to the public is established. The logo shall be clearly displayed on websites offering veterinary medicinal products for sale at a distance. 3. A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering veterinary medicinal products for sale at a distance to the public is established. The logo shall be clearly displayed on websites offering veterinary medicinal products for sale at a distance.

4. The Commission shall adopt the design of the common logo by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 4. The Commission shall adopt the design of the common logo by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

5. Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information: 5. Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information:

(a) information on its national legislation applicable to the offering of veterinary 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 the classification of the supply of the veterinary medicinal products; (a) information on its national legislation applicable to the offering of veterinary medicinal products for sale at a distance on the internet , including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products;

(b) information on the common logo; (b) information on the common logo;

(c) a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in accordance with paragraph 1 as well as the website addresses of those retailers. (c) a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to the public on the internet in accordance with paragraph 1 as well as the website addresses of those retailers ; and also a hyperlink to the website of the Agency set up in accordance with paragraph 6;

(ca) information on applicable procedures for the safe disposal of medicinal products, specifying the public or private body responsible at national or local level for the disposal of veterinary medicine residues and the collection points for disposal free of charge;

(cb) hyperlinks to the web pages of the bodies responsible in Member States for listing authorised national retailers.

The websites set up by Member States shall contain a hyperlink to the website of the Agency set up in accordance with paragraph 6.

6. The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the Member State concerned. 6. The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public on the internet in the Member State concerned. The Agency’s website shall be linked to the web pages of the appropriate Member State bodies which list authorised retailers in Member States.

7. Members States may impose conditions, justified on grounds of public health protection, for the retail on their territory of medicinal products offered for sale at a distance to the public by means of information society services.

7a. Member States shall take the measures necessary to ensure that persons other than those referred to in paragraph 1 offering veterinary medicinal products for sale at a distance to the public on the internet and operating on their territory are subject to effective, proportionate, and dissuasive penalties in case of abuse or illegal practice, or the failure to act according to their professional code of conduct.

7b. No later than (six) months after the date of application of this Regulation, the Commission shall adopt guidelines supporting the Member States in the development of a harmonized system of digital prescription across the Union, including measures for controlling cross-border veterinary prescriptions.