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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)

article  55

CELEX:  02019R0006-20220128

Union database on veterinary medicinal products
1. The Agency shall establish and, in collaboration with the Member States, maintain, a Union database on veterinary medicinal products (‘product database’).
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)

article  55

CELEX:  02019R0006-20220128

2. The product database shall contain at least the following information:
(a) for veterinary medicinal products authorised within the Union by the Commission and by the competent authorities:
(i) name of the veterinary medicinal product;
(ii) active substance or substances, and the strength of the veterinary medicinal product;
(iii) summary of product characteristics;
(iv) package leaflet;
(v) the assessment report;
(vi) list of sites where the veterinary medicinal product is manufactured; and (vii) the dates of the placing of the veterinary medicinal product on the market in a Member State;
(b) for homeopathic veterinary medicinal products registered in accordance with Chapter V within the Union by the competent authorities:
(i) name of the registered homeopathic veterinary medicinal product;
(ii) package leaflet; and (iii) lists of sites where the registered homeopathic veterinary medicinal product is manufactured;
(c) veterinary medicinal products allowed to be used in a Member State in accordance with Article 5(6);
(d) the annual volume of sales and information on the availability for each veterinary medicinal product.
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)

article  55

CELEX:  02019R0006-20220128

3. The Commission shall, by means of implementing acts, adopt the necessary measures and practical arrangements laying down:
(a) the technical specifications of the product database including the electronic data exchange mechanism for exchanging with the existing national systems and the format for electronic submission;
(b) the practical arrangements for the functioning of the product database, in particular to ensure protection of commercially confidential information and security of exchange of information;
(c) detailed specifications of the information to be included, updated and shared in the product database and by whom;
(d) contingency arrangements to be applied in case of unavailability of any of the functionalities of the product database;
(e) where appropriate, data to be included in the product database in addition to the information referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).