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Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)
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1.Only veterinary medicinal products that are authorised or registered in a Member State may be advertised in that Member State, unless otherwise decided by the competent authority in accordance with applicable national law.
2.The advertising of a veterinary medicinal product shall make it clear that it aims at promoting the supply, sale, prescription, distribution or use of the veterinary medicinal product.
3.The advertising shall not be formulated in such a way as to suggest that the veterinary medicinal product could be a feed or a biocide.
4.The advertising shall comply with the summary of the product characteristics of the advertised veterinary medicinal product.
5.The advertising shall not include information in any form which could be misleading or lead to incorrect use of the veterinary medicinal product.
6.The advertising shall encourage the responsible use of the veterinary medicinal product, by presenting it objectively and without exaggerating its properties.
7.The suspension of a marketing authorisation shall preclude any advertising, during the period of that suspension, of the veterinary medicinal product in the Member State in which it is suspended.
8.Veterinary medicinal products shall not be distributed for promotional purposes except for small quantities of samples.
9.Antimicrobial veterinary medicinal products shall not be distributed for promotional purposes as samples or in any other presentation.
10.The samples referred to in paragraph 8 shall be appropriately labelled indicating that they are samples and shall be given directly to veterinarians or other persons allowed to supply such veterinary medicinal products during sponsored events or by sales representatives during their visits.
1.The advertising of veterinary medicinal products that are subject to veterinary prescription in accordance with Article 34 shall be allowed only when made exclusively to the following persons:
(a)veterinarians;
(b)persons permitted to supply veterinary medicinal products in accordance with national law.
2.By way of derogation from paragraph 1 of this Article, advertising of veterinary medicinal products that are subject to veterinary prescription in accordance with Article 34 to professional keepers of animals may be permitted by the Member State provided the following conditions are met:
(a)the advertising is limited to immunological veterinary medicinal products;
(b)the advertising includes an express invitation to the professional keepers of animal to consult the veterinarian about the immunological veterinary medicinal product.
3.Notwithstanding paragraphs 1 and 2, the advertising of inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link shall be prohibited.
1.Where medicinal products are being promoted to persons qualified to prescribe or supply them in accordance with this Regulation, no gifts, pecuniary advantages or benefit in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of prescription or supply of medicinal products.
2.Persons qualified to prescribe or supply medicinal products as referred to in paragraph 1 shall not solicit or accept any inducement prohibited under that paragraph.
3.Paragraph 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 objectives of the event.
4.Paragraphs 1, 2 and 3 shall not affect existing measures or trade practice in Member States relating to prices, margins and discounts.
Member States may lay down any procedures they deem necessary for the implementation of Articles 119, 120 and 121.
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