Traduction de «médicament de référence » (Français → Anglais) :

brand-name drug

innovator brand | originator | originator brand | originator medicinal product | originator medicine | originator pharmaceutical | originator pharmaceutical product | originator product

active-controlled trial | active controlled trial | active-controlled study | active controlled study

brand name drug

over-the-counter drug [ non-prescription drug | non-prescription medicinal product | OTC drug | OTC medicine | over-the-counter medicine ]

controlled-release drug

Open Systems Interconnection reference model | OSI-RF | Open Systems Interconnect reference model | OSI reference model | Open Systems Interconnection model | OSI model | Open Systems Interconnection | Open System Interface | ISO/OSI reference model | OSI

Archival Citations: Suggestions for the Citation of Documents at the Public Archives of Canada [ Archival Citations | Suggestions for the Citation of Documents at the Public Archives of Canada ]

3. Where the reference veterinary medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted, or the application is submitted in accordance with Article 38(3) where the reference medicinal product was authorised in a Member State, the applicant shall indicate in its application the Member State in which the reference veterinary medicinal product has been authorised.

(6) ‘generic veterinary medicinal product’ means a veterinary medicinal product which has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference medicinal product, and with regard to which appropriate bioavailability studies have demonstrated a bioequivalence with the reference veterinary medicinal product.

On a proper construction of Article 10 of Directive 2001/83, as amended by Regulation No 1394/2007, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, the holder of a marketing authorisation for a medicinal product used as a reference product in an application for a marketing authorisation under Article 10 of the directive for a generic product of another manufacturer has the right to a judicial remedy enabling him to challenge the decision of the competent authority which granted the marketing authorisation for the generic product, provided that that holder is seeking judicial protection of a ...[+++] right conferred on him by Article 10.

In establishing these rules, a distinction should be made between investigational medicinal products (the tested product and its reference products, including placebos) and auxiliary medicinal products (medicinal products used in the context of a clinical trial but not as investigational medicinal products), such as medicinal products used for background treatment, challenge agents, rescue medication, or used to assess end-points in a clinical trial.