Traduction de «An Act respecting the Practice Physical Therapy » (Anglais → Français) :

He said: Mr. Speaker, I am honoured to introduce a bill entitled, an act respecting corporate practices relating to the extraction, processing, purchase, trade and use of conflict minerals from the Great Lakes Region of Africa.

The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use , and adapted, where necessary, to reflect the specific nature of t ...[+++]hose products.

It should also be clarified that products which do not meet the definition of a medicinal product, such as products made exclusively of non-viable materials which act primarily by physical means, cannot by definition be advanced therapy medicinal products.

Considers that Member States should, when not already the case, establish or recognise public agencies or dedicated bodies like an adjudicator, at national level with responsibility for enforcing action to combat unfair practices in the food supply chain; takes the view that public agencies of this kind can facilitate enforcement, e.g. by being empowered to open and conduct investigations on their own initiative and on the basis of informal information or complaints dealt with on a confidential basis (thus overcoming the ‘fear factor’), and can act as a mediator between the parties involved; stresses the need for mutual recognition and ...[+++] effective cooperation at EU level between national authorities to ensure sharing of relevant information, particularly on good practice, and expertise concerning new types of UTPs, acting in full respect for the principle of subsidiarity.

The manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use , and adapted, where necessary, to reflect the specific nature of t ...[+++]hose products.

It should also be clarified that products which do not meet the definition of a medicinal product, such as products made exclusively of non-viable materials which act primarily by physical means, cannot by definition be advanced therapy medicinal products.