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PSD Home | Applicant Information | Approval Holder Letters Judicial review of the UK parallel import arrangements: R -v- MAFF exparte BAADate: 19 November 1999Dear Sir/MadamJudgement in the above case was handed down by Mr Justice Richards in the High Court on 4 November. PSD will decide whether an appeal should be lodged but in the meantime it is carefully considering the implications of the judgement . The judgement requires that PSD should insist on exact equivalence of formulations to establish the identicality of the parallel import to the master product. In the light of this, PSD may now require additional supporting documentation for current and future parallel import applications. In addition we intend to contact the regulatory authorities of other countries to help us establish that the product to be imported is identical to the UK-approved master product. A further announcement will be made following the outcome of the current deliberations. If you have any queries concerning this matter, please do not hesitate to write to either myself or Mr Russell Wedgbury at the above address. I may also be contacted by telephone on 01904 45 5708, by fax on 01904 45 5733 or by e-mail to s.tuffnell@psd.maff.gsi.gov.uk. Mr Wedgbury may also be contacted by telephone on 01904 45 5749, by fax on 01904 45 5733 or by e-mail to r.wedgbury@psd.maff.gsi.gov.uk. Yours faithfully SON TUFFNELL |
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