The application for marketing authorisation is accompanied by a draft summary of product characteristics, the presentation and content of which are laid down in accordance with Article 14 of Directive 2004 / 28 / EC of 31 March 2004 by order of the Ministers for Agriculture and Health on a proposal from the Director General of the National Agency for Food, Environmental and Occupational Health Safety.
The drafts of the outer and primary packaging and, where applicable, the draft leaflet, are attached to the summary of product characteristics.