Safety, Quality, Efficacy: Regulating Medicines in the UK

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SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK Appendix 5 Trends in workload levels Trends in the volume of new active substance applications number of applications 50 45 40 35 30 25 20 15 10 5 0 1995-96 1996-97 1997-98 1998-99 1999-2000 2000-01 2001-02 Trends in the volume of variations to licences 25000 number of applications for variations 20000 15000 10000 5000 0 1995-96 1996-97 1997-98 1998-99 1999-2000 2000-01 2001-02 Trends in the volume of abridged licence applications Trends in the volume of applications for parallel import licences Trends in the volume of applications for licence renewal 1200 3000 25000 number of applications 1000 800 600 400 200 number of applications 2500 2000 1500 1000 500 number of applications 20000 15000 10000 5000 0 1997-98 1998-99 1999-2000 2000-01 2001-02 0 1997-98 1998-99 1999-2000 2000-01 2001-02 0 1997-98 1998-99 1999-2000 2000-01 2001-02 Source: Medicines Control Agency appendix five 45
SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK Appendix 6 Parallel import licensing Planet Pharmaceuticals makes both Hypotensine Tablets in France and Normotensin Tablets in the UK. The tablets are very similar but Hypotensine costs 10 and Normotensin costs £10 per packet. A Parallel Importer Discopharm intends to import the cheaper Hypotensine Tablets from France into the UK using Normotensin as the UK reference product. It will be sold under the trade name Normotensin and the generic name hypotensolol. Discopharm applies for a PL(PI) licence to import the product Discopharm applies for a Wholesale Dealers Licence to supply the product to pharmacies Discopharm applies for a Manufacturer's (Assembly Only) Licence to repackage and overlabel the product Medicines Control Agency obtains information on Hypotensine Tablets from the French Regulatory Authority Discopharm's manufacturing and storage sites are inspected by UK Medicines Inspectorate Information on the UK and French products is compared. A formulation difference is noted so queries are sent to the UK marketing authorisation holder Planet Ltd and the French marketing authorisation holder Planet SA At the same time the existence of a link between Planet SA and Planet Ltd is verified. They are both part of the Planet Pharmaceuticals Group The outcome of these enquiries is satisfactory Some changes to documentation procedures are agreed The proposed product labelling and Patient Information Leaflet are checked to ensure that they comply with regulations and include all information relevant to the imported product. A revised Patient Information Leaflet to include an additional adverse effect has recently been issued for Hypotensine in the UK so amendments are requested to the leaflet for the imported product A licence to import the product is issued A Manufacturer's (Assembly Only) Licence and a Wholesale Dealer's Licence are issued appendix six NOTE All names in italics are fictitious. The UK marketing authorisation holder is advised of the grant of the PL(PI) licence 46 Source: Medicines Control Agency
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Safety, Quality, Efficacy: Regulating Medicines in the UK

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