Traduction de «Product characteristics » (Anglais → Français) :

The term ’technical specification’ also covers production methods and processes used in respect of agricultural products as referred to Article 38(1), second subparagraph of the TFEU, products intended for human and animal consumption, and medicinal products as defined in Article 1 of Directive 2001/83/EC of the European Parliament and of the Council , as well as production methods and processes relating to other products, where these have an effect on their characteristics;

(16) The widening variety of fishery and aquaculture products makes it essential to provide consumers with a minimum amount of mandatory It is necessary for consumers to be provided with clear and comprehensive information on, inter alia, the main characteristics of products. In order to promote differentiation of products, it is also necessary to take account of additional information that may be indicated on a voluntary basis origin, method and date of production of the products in order to enable them to make informed choices . [Am ...[+++]. 15]

(a) medicinal products placed on the market on the territory of that Member State. Such information shall include, but shall not be limited to, the most recent summary of product characteristics and labelling and package leaflet of the medicinal product as approved by the competent authorities during the course of marketing authorisation and its renewal, and the most recent, publicly accessible version of the assessment report as drawn up by the competent authorities, and updates thereof;

This situation has some undesirable repercussions: namely, it entails an unjustified additional administrative burden for the competent authorities and pharmaceutical businesses; logistical issues for the actual implementation of changes; and widely differing deadlines for introducing changes to the summary of characteristics of the product and the information leaflet for health care personnel and patients, with a knock-on effect on the overall working of the single market in pharmaceutical products. Lastly, it adversely affects patients, since the introduction of some changes that improve the effectiveness of a medicine may be delayed ...[+++] or, worse, never happen at all.

Advanced Therapy medicinal products have specific characteristics that differ greatly from traditional medicinal products. That leads to important differences in their manufacturing process (e.g. in Article 11.4. the GMP Directive requires that sample batches of finished products should be kept for 1 year after expiry date. It is, however, difficult to consider expiry dates for certain classes of ATMPs).

One product we are pretty excited about is nano- crystalline cellulose, NCC, which is an extraction of forest fibre at its nano level to be able to manipulate cellulose at the nano level to give it a whole different set of characteristics than what you would normally expect from fibre — the way it passes light, the way it is aligned to create different strength characteristics that you would never expect from forests, as well as durability characteristics.