Traduction de «Establish products' features » (Anglais → Français) :

1. The repositories system where the information on the safety features shall be contained, pursuant to Article 54a(2)(e) of Directive 2001/83/EC, shall be set up and managed by a non-profit legal entity or non-profit legal entities established in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features.

In order to better take into account the specific nature of natural disasters which, although having serious repercussions for the economic and social development of the regions concerned, do not reach the minimum scale required to benefit from a financial contribution from the Fund, the criteria for regional natural disasters should be determined based on the damage calculable by reference to regional gross domestic product (GDP), whereby the specific structural social and economic situation, compounded by the special features of Guadeloupe, Fren ...[+++]ch Guiana, Martinique, Réunion, Mayotte, Saint-Martin, the Azores, Madeira and the Canary Islands, as outermost regions within the meaning of Article 349 TFEU, justifies the establishment for them of a special threshold of 1 % of the GDP as a derogation.

In order to ensure uniform conditions for the implementation of this Directive implementing powers should be conferred on the Commission concerning the laying down and updating of a priority list of additives for enhanced reporting, the laying down and updating of the format for the reporting of ingredients and for the dissemination of that information, determining whether a tobacco product has a characterising flavour or has increased levels of toxicity, addictiveness or CMR properties, the methodology for determining whether a tobacco product has a characterising flavour, the procedures for the establishment and operation of an independent advisory panel for determining tobacco products ...[+++] with characterising flavours, the precise position of health warnings on pouches of roll-your-own tobacco, the technical specifications for the layout, design, and shape of combined health warnings, the technical standards for the establishment and operation of the tracking and tracing system, for ensuring the compatibility of the systems for the unique identifiers and for the security features, as well as establishing a common format for notification of electronic cigarettes and refill containers and the technical standards for the refill mechanisms for such products.

When implementing Article 15 of Directive 2003/87/EC, it is necessary to ensure a synergy between the comprehensive framework for accreditation established by Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 and related provisions of Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the m ...[+++]arketing of products, and repealing Council Decision 93/465/EEC on one hand, and the specific features of the Union’s greenhouse gas emission trading scheme and requirements that are essential for the effective implementation of Directive 2003/87/EC on the other hand.

(e)provisions on the establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products, as provided for in point (o) of Article 54, shall be contained.

Whereas it is necessary, before including a new product in one of the groups concerned, to ascertain that it has the required nutritional value ; whereas it must be established that these products, when used sensibly, have no detrimental effect on human or animal health or on the environment and do not harm the consumer by impairing the distinctive features of animal products;