Marketing Authorisation - Medicinal Products
By www.menhealthonline.biz
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).
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.
Product A - was authorised by the European Community in 1993;
Product B - was authorised in 2000
Product C - was a generic product based on Product B (a copy of Product B).
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.
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).
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 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
