Regulatory Data Protection in the Pharmaceutical and Other Industries 1st Edition

Regulatory Data Protection in the Pharmaceutical and Other Industries

Trevor Cook

Sweet & Maxwell, 1st Edition - December 1999.

This is the first book to show how different countries have gone about formulating the protection of regulatory data in their national laws.

Chapters


  1. The Protection of Regulatory Data Generally 
    Trevor Cook

  2. Regulatory Data Protection of Medicinal Products in the European Community 
    Trevor Cook

  3. Regulatory Data Protection in the European Community Other Than of Medicinal Products 
    Trevor Cook

  4. The United States Trevor Cook

  5. Australia and New Zealand – Trevor Cook

  6. The Protection of Regulatory Data in Other Countries Trevor Cook

  7. Appendices ECJ case law – Trevor Cook

1. The Protection of Regulatory Data Generally
Introduction, contrast of regulatory data protection with other forms of market exclusivity, its treatment in TRIPs and the background to and legislative history of this.

2. Regulatory Data Protection of Medicinal Products in the European Community
Comparison of regulatory data protection in Europe with patents and supplementary protection certificates, legislative history of the regulatory data protection regime in Europe as to medicinal products, the published dataexception and the ten year rule.

3. Regulatory Data Protection in the European Community Other Than of Medicinal Products
Regulatory Data Protection in the European Community for plant protection products, animal feeding stuffs, biocidal products and flavouring additives.

4. The United States
Regulatory data protection for pesticides and for pharmaceuticals and the legislative history of this.

5. Australia and New Zealand
Regulatory data protection for medicines in New Zealand and for therapeutic goods, veterinary chemicals and agricultural chemicals in Australia.

6. The Protection of Regulatory Data in Other Countries
Regulatory data protection under regional arrangements such as NAFTA and the Andean pact and in specfic countries, notably Argentina, Canada, and Japan.

7. Appendices ECJ case law
- R v Licensing Authority, ex parte Scotia - R v Licensing Authority, ex parte Generics.

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