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Regulatory Impact Assessment: The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

  • Document type:
    Regulatory impact assessment
  • Author:
    Department of Health
  • Published date:
    1 December 2004
  • Primary audience:
    Health and social care professionals
  • Gateway reference:
    not required
  • Pages:
    13
  • Copyright holder:
    Crown

This Regulatory Impact Assessment to introduce an incentive to widen the availability of non-prescription medicinal products in line with UK Government objectives to widen availability of medicines for human use; to enhance the safe use of medicines for human use by changes to the patient information and "user testing"; to reinforce the obligations of Marketing Authorisation (MA) holders to provide information impacting on the benefits and risks of medicines human use and so strengthening regulation and increasing patient safety.

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