Regulatory data protection for medicines

Issue  JCB, Volume 11, Number 1, 2004  Legal and Regulatory Updates 

John Wilkinson
Frederick J Dorey

DOI:https://doi.org/10.5912/jcb105


Abstract:

Pending the coming into force in November 2005 of the changes to the regulatory data protection regime under European Medicines Legislation to be effected under the 'Future Medicines Legislation', the European Court of Justice (ECJ) continues to deal with cases referred to it concerning the existing law of regulatory data protection. Thus it gave Judgment on 29th April, 2004, in The Queen (on the application of Novartis Pharmaceuticals UK Ltd) v The Licensing Authority established under the Medicines Act 1968 (acting by the Medicines Control Agency), and the Advocate General gave his Opinion on 8th July, 2004, in Approved Prescription Services v The Licensing Authority (acting by the Medicines Control Agency).

Keywords:en ,

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