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Marketing Authorisation - Medicinal Product

Author : Clementine Robertson


Promoting Authorisation: Medicinal Products The case of R (on the appliance of Merck Sharp and Dohme Ltd) v Licensing Authority [2005], concerned the application for promoting authorisation for a generic product which was based on Product C (see below).
The claimant had marketing authorisations for 3 medicinal products employed in the treatment of osteoporosis and three generic corporations sought selling authorisation for Product C.
Product A - was authorised by the European Community in 1993;
Product B - was authorised in 2000
Product C - was a generic product primarily based on Product B (a replica of Product B).
When a corporation applies for selling authorisation for a product, it's a demand under the European Parliament and Council Directive (EC) 2001/eighty three (the "Directive"), to provide a full set of data in order to point out the safety and efficacy of the product.
There are instances below the Directive when an applicant will merely depend on data submitted in respect of a previously authorised product. As an example, the applicant could consult with information already submitted in respect of a product with marketing authorisation, where the applicant is seeking authorisation for a product 'basically 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).
In seeking selling authorisation for Product C, the generic corporations relied on knowledge submitted in relation to Product A and Product B. But, though Product A and Product B contained the identical active ingredient, they weren't 'primarily similar' inside the that means of the Directive. This meant that they differed in respect of their posology (the schedule of dosage). The defendant accepted that the generic corporations did not have to supply any further information however 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").
The claimant contended that the issue was as nonetheless unresolved by the rules laid down in previous selections of the ECJ. In particular, it had been argued, that there had been no cases where a distinction in posology had been the topic of a decision.
The application was dismissed. The ECJ held that:
The principles laid down by the ECJ in earlier decisions were clearly applicable in this case and there was no uncertainty;
Although it had been true that a amendment in posology had not previously been the topic of a decision, it had been for the ECJ to interpret the EC Treaty and the relevant principles by that it had been to be interpreted, and for the domestic court to apply those principles to the actual case.
No new principles arose in the moment case.


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Jeff Patterson has been writing articles online for nearly 2 years now. Not only does this author specialize in Productivity, you can also check out his latest website about


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Submitted : 2011-01-03    Word Count : 503    Times Viewed: 172