Traduction de «Boîte de direction » (Français → Anglais) :

The manufacturer placing the safety features shall keep records of every operation he performs with or on the unique identifier on a pack of medicinal product for at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period, and shall provide those records to competent authorities on request.

For this reason, the character sequence resulting from the combination of the product code and the serial number sequence should be unique to a given pack of a medicinal product until at least one year after the expiry date of that pack or five years after the product has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.

The provision of investment services by those entities in respect of AIFs should never amount to a de facto circumvention of this Directive by means of turning the AIFM into a letter-box entity, irrespective of whether the AIFM is established in the Union or in a third country.

Controlling the vehicle; taking into account: proper use of safety belts, rear-view mirrors, head restraints; seat; proper use of lights and other equipment; proper use of clutch, gearbox, accelerator, braking systems (including third braking system, if available), steering; controlling the vehicle under different circumstances, at different speeds; steadiness on the road; the weight and dimensions and characteristics of the vehicle; the weight and type of load (categories BE, C, CE, C1, C1E, DE, D1E only); the comfort of the passengers (categories D, DE, D1, D1E only) (no fast acceleration, smoothly driving and no hard braking) ...[+++].

For the purposes of the provisions of this Directive setting out conditions for outsourcing critical or important operational functions or investment services or activities, an outsourcing that would involve the delegation of functions to the extent that the firm becomes a letter box entity should be considered to undermine the conditions with which the investment firm must comply in order to be and remain authorised in accordance with Article 5 of Directive 2004/39/EC.

However, some problems persist, in particular as regards the contents of medicine chests, which do not always correspond to all of the Directive’s requirements, and the replacement of drugs and medical supplies that have passed their expiry date.