Data fields to record the information referred to in Article 55(2) of Regulation (EU) 2019/6
ANNEX IISupplementary provisions
ANNEX II Data fields to record the information referred to in Article 55(2) of Regulation (EU) 2019/6 Data Field ID Data Field Description Format 1. For all veterinary medicinal products 1.1 Product Domain A statement that the entry is a veterinary medicinal product to distinguish between veterinary medicinal products and medicinal products for human use. Controlled terms 1.2 Product Type Distinction between authorised veterinary medicinal products, registered homeopathic veterinary medicinal products, veterinary medicinal products allowed to be used in a Member State in accordance with Article 5(6) of Regulation (EU) 2019/6 or exempted from the provisions in Articles 5 to 8 of Directive 2001/82/EC in accordance with Article 4(2) of the same Directive, as applicable, and parallel-traded veterinary medicinal products. Controlled terms 1.3 Product Name The name of the veterinary medicinal product as approved in the Union or in a Member State. Free text 1.4 Active Substance(s) Name of the active substance or substances. Controlled substance terms 1.5 Strength/Composition The content of active substances in a veterinary medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the pharmaceutical form. Structured data Biological activity, potency or titre in case of immunological veterinary medicinal products. Structured data or, where not possible for justifiable reasons, free text. 1.6 Manufacturing Sites List of the sites where the veterinary medicinal product is manufactured. Controlled organisation data 1.7 Documents Documents to be attached to veterinary medicinal product record, including selection of type (summary of product characteristics, package leaflet, labelling and assessment report). Controlled terms for document types plus documents uploaded in the format laid down in this Regulation 2. Only for authorised veterinary medicinal products 2.1 Dates of Placing on the Market The dates of the placing of the veterinary medicinal product on the market in each Member State. Date 2.2 Annual Volume of Sales Annual volume of sales of veterinary medicinal products. Structured data 2.3 Date of Availability Status Date of the marketing status. Date 2.4 Availability Status Marketing status: product available on the market per Member State. Controlled terms