Traduction de «système d'agrément des établissements pharmaceutiques » (Français → Anglais) :

4. Where national law permits, and with the express consent of the competent authorities which issued its authorization, a credit institution excluded from a deposit-guarantee scheme may continue to take deposits if, before its exclusion, it has made alternative guarantee arrangements which ensure that depositors will enjoy a level and scope of protection at least equivalent to that offered by the officially recognized scheme.

(25) An accreditation system for tissue establishments and a system for notification of adverse events and reactions linked to the procurement, testing, processing, preservation, storage and distribution of human tissues and cells should be established in the Member States.

An accreditation system for tissue establishments and a system for notification of adverse events and reactions linked to the procurement, testing, processing, preservation, storage and distribution of human tissues and cells should be established in the Member States.

The intent is to take the existing things we register and license and collapse the dual system into one comprehensive licensing scheme, whether it's for a permit, a registration of an establishment, or a licence to allow someone to operate an establishment.

D) Health measures * radioactivity checks on imported EC foodstuffs; * ban on dairy product additives (nisin); * zero tolerance for residues in livestock products; * processed meat: approval of processors and veterinary certification system; * additive rules for baked goods; * prior registration: tomato juice and sauces, fruit juices.

Following the specific amendments agreed by the Commission, the proposal now: - makes clear that a credit institution that also acted as an investment firm could belong to a single compensation scheme as long as the scheme met the requirements of both the deposit-guarantee Directive and the investor compensation Directive - incorporates equivalent clauses to the bank deposit-guarantee Directive concerning the possibility for branches to opt-in to higher levels of compensation in the host country ('top-up'), the regime for branches of firms with their head office in a non-EU country (Member States must ensure home countries schemes offer ...[+++]equivalent cover or oblige branches to join the host country scheme) and the principle that schemes should be financed by investment firms themselves - includes revised definitions of "investment firm" and "branch" which refer to the definitions in the Investment Services Directive and a new definition of "joint investment" - clarifies that authorisation for investment firms is based on the principle of home country control and that no investment firm (other than credit institutions exempted under the deposit-guarantee Directive) could operate unless it participated in an investor compensation scheme - simplifies the definition of when and how the amount of an investor's claim should be determined - makes a specific reference to the exclusion from compensation of any transaction in connection with which there has been a conviction for money-laundering as defined by the Directive on the issue (91/308/EEC) - includes a requirement for continued coverage by the compensation scheme even when a firm's authorisation to operate has been withdrawn (in case it should subsequently transpire that the firm was unable to meet its commitments to investors) - requires the Commission to report on the Directive's operation three years after it is due to be implemented (31.12.96) rather than five years after.