Traduction de «Conformité aux autorisations » (Français → Anglais) :

(7) Although conformity assessment should be the responsibility of the manufacturer without any need to involve an independent conformity assessment body, in order to facilitate the completion of the conformity assessment procedure, manufacturers should be allowed to seek assistance of an independent conformity assessment laboratory.

4. If an institution has received permission to apply an approach that requires permission by the competent authorities before using such an approach for the calculation of own funds requirements in accordance with Part Three of Regulation (EU) No 575/2013 but does not meet the requirements for applying that approach anymore, the competent authorities shall require the institution to either demonstrate to the satisfaction of the competent authorities that the effect of non-compliance is immaterial where applicable in accordance with Regulation (EU) No 575/2013 or present a plan for the timely restoration of compliance with the requiremen ...[+++]ts and set a deadline for its implementation.

If the institution is unlikely to be able to restore compliance within an appropriate deadline and, where applicable, has not satisfactorily demonstrated that the effect of non-compliance is immaterial, the permission to use the approach shall be revoked or limited to compliant areas or those where compliance can be achieved within an appropriate deadline.

5a. Where pressure receptacles were manufactured in a series, Member States may authorise the reassessment of conformity of individual pressure receptacles, including their valves and other accessories used for transport, to be carried out by a notified body notified for periodic inspection of the relevant transportable pressure receptacles provided that conformity of the type has been assessed in accordance with paragraph 3 by a type A notified body, responsible for reassessment of conformity, and a certificate of type reassessment issued.

n ) copies of any marketing authorization obtained in another Member State or in a third country for the relevant veterinary medicinal product, together with a list of those Member States in which an application for authorization submitted in accordance with this Directive is under examination. Copies of the summary of the product characteristics proposed by the applicant in accordance with Article 14 or approved by the competent authority of the Member State in accordance with Article 25 and copies of the package insert proposed, details of any decision to refuse authorization, whether in the Community or a third country and the reasons ...[+++] for that decision; all this information shall be updated on a regular basis;

(15) The conditions, which may be attached to the general authorisation and to the specific rights of use, should be limited to what is strictly necessary to ensure compliance with requirements and obligations under Community law and national law in accordance with Community law.