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marketing Authorisation - Medicinal Products</b><br>
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<title>marketing Authorisation - Medicinal Products<BR>By www.menhealthonline.biz<BR><authorname>Generic Medications. Online Pharmacy</authorname>
<authordesc>A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a licence Are generic drugs just as good as brand name drugs? discusses this issue.
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<p>Marketing Authorisation: Medicinal Products The case of R (on the application of Merck Sharp and Dohme Ltd) v Licensing Authority [2005], concerned the application for marketing authorisation for a generic product which was based on Product C (see below).</p><p>The claimant had marketing authorisations for three medicinal products used in the treatment of osteoporosis and three generic companies sought marketing authorisation for Product C.</p><p>Product A - was authorised by the European Community in 1993;</p><p>Product B - was authorised in 2000</p><p>Product C - was a generic product based on Product B (a copy of Product B).</p><p>When a company applies for marketing authorisation for a product, it is a requirement under the European Parliament and Council Directive (EC) 2001/83 (the "Directive"), to supply a full set of data in order to show the safety and efficacy of the product.</p><p>There are instances under the Directive when an applicant can simply rely on data submitted in respect of a previously authorised product. For instance, the applicant could refer to data already submitted in respect of a product with marketing authorisation, where the applicant is seeking authorisation for a product 'essentially similar' to a product holding a marketing authorisation for ten years (as per the United Kingdom and pursuant to art 10(i)(a)(iii) of the Directive).</p><p>In seeking marketing authorisation for Product C, the generic companies relied on data submitted in relation to Product A and Product B. However, although Product A and Product B contained the same active ingredient, they were not 'essentially similar' within the meaning of the Directive. This meant that </span></p>
<p class="mytext"><span class="mytext"><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/ugXgT0RwT6k/saphris-asenapine-maleate-safety-communication-serious-allergic-reactions-13022.html'\>Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/Beh6BcyAvLU/reclast-zoledronic-acid-safety-communication-new-updated-warning-kidney-impairment-13020.html'\>Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/-gNQA8Cs-n8/h-38-p-industries-povidone-iodine-swabsticks-prep-solutions-scrub-solutions-prep-gel-recall-13018.html'\>H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/16L__GdVRn0/celexa-citalopram-hydrobromide-safety-communication-abnormal-heart-rhythms-associated-doses-13017.html'\>Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/0zaCeMGwMl8/vasopressin-usp-multiple-vials-recall-sub-potency-13016.html'\>Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/M1xPKBSdVhs/recombinant-human-growth-hormone-somatropin-ongoing-safety-review-possible-increased-risk-death-13015.html'\>Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/AIwoartvVno/diflucan-fluconazole-safety-communication-long-term-during-pregnancy-may-associated-birth-defects-13013.html'\>Diflucan (fluconazole): Drug Safety Communication - Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/2Ria0b2d7Iw/slim-forte-slimming-capsules-slim-forte-slimming-coffee-botanical-slimming-soft-gel-public-13009.html'\>Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification - Undeclared Drug Ingredient</a></font></span></p>
<p class="mytext"><span class="mytext">they differed in respect of their posology (the schedule of dosage). The defendant accepted that the generic companies did not have to provide any further data but the claimant argued that such an approach was unlawful and in breach of the Directive. The claimant made a reference to the European Court of Justice ("Court of Justice").</p><p>The claimant contended that the issue was as yet unresolved by the rules laid down in previous decisions of the ECJ. In particular, it was argued, that there had been no cases where a difference in posology had been the subject of a decision.</p><p>The application was dismissed. The ECJ held that:</p><p>The principles laid down by the ECJ in earlier decisions were clearly applicable in this case and there was no uncertainty;</p><p>Although it was true that a change in posology had not previously been the subject of a decision, it was for the ECJ to interpret the EC Treaty and the relevant principles by which it was to be interpreted, and for the domestic court to apply those principles to the particular case. <br>No new principles arose in the instant case.</p><p>If you require further information contact us.</p><p>Email: enquiries@rtcoopers.com</p><p>© RT COOPERS, 2005. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.</p><p>Rosanna Cooper is a partner in RT Coopers Solicitors a full service law firm in London. The firm specialises in patents, trade marks, copyright, designs, technology transfer, biotechnology and pharmaceutical law. The firm has a flexible approach to fees and provides the highest quality legal advice.</p><p>Contact us at <a href="mailto:enquiries@rtcoopers.com">enquiries@rtcoopers.com</a>. visit our website at <a target="_new" href="http://www.rtcoopers.com">http://www.rtcoopers.com</a></p><BR>Medications and prescription drug information for consumers and medical health professionals. The most popular drugs and their side effects.</span></p>
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<p class="mytext"><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/ugXgT0RwT6k/saphris-asenapine-maleate-safety-communication-serious-allergic-reactions-13022.html'\>Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/Beh6BcyAvLU/reclast-zoledronic-acid-safety-communication-new-updated-warning-kidney-impairment-13020.html'\>Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/-gNQA8Cs-n8/h-38-p-industries-povidone-iodine-swabsticks-prep-solutions-scrub-solutions-prep-gel-recall-13018.html'\>H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/16L__GdVRn0/celexa-citalopram-hydrobromide-safety-communication-abnormal-heart-rhythms-associated-doses-13017.html'\>Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/0zaCeMGwMl8/vasopressin-usp-multiple-vials-recall-sub-potency-13016.html'\>Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency</a></font><font style='font-size: 12px;'><a target=_blank href ='http://feeds.drugs.com/~r/Drugscom-FdaMedwatchAlerts/~3/M1xPKBSdVhs/recombinant-human-growth-hormone-somatropin-ongoing-safety-review-possible-increased-risk-death-13015.html'\>Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death</a></font></p>
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