Legal Updates

Pharmaceutical: Marketing Authorisation for Medicinal Products

The Court of Justice of the European Communities in the application of Approved Prescription Services Ltd v Licensing Authority (Case C-36/03), held that an application can be made for marketing authorisation under 10(1)(a)(iii) of the Parliament and Council Directive (EC) 2001/38 ("the Directive"), for a new medicinal Product C (see below).

Article 10(1) of the Directive, so far as is material, provides that:

   1. "The applicant shall not be required to provide the results of toxicological and pharmacological tests or the results of clinical trials if he can demonstrate: ... (iii) ... that the medicinal product is essentially similar to a medicinal product which had been authorised within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made ... a Member State may ... extend this period to 10 years by a single Decision covering all the medicinal products marketed on its territory where it considers this necessary in the interest of public health ... However, where the medicinal product is intended for a different therapeutic use from that of the other medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate toxicological and pharmacological tests and/or of appropriate clinical trials must be provided."

In the application to the respondent, acting by the Medicines and Healthcare products Regulatory Agency (MHRA), the applicant claimed that Product C was essentially similar to Product B. Product B was a new pharmaceutical form of Product A. However, the medicinal Product A, but not Product B, had been authorised for marketing in the Community for at least six or ten years earlier.

This case concerned three medicinal products, each of them containing the active ingredient Fluoxetine. Two of those medicinal products were produced by Company E, the interested party:

    * Product A - Prozac capsules, authorised in the United Kingdom in November 1988.
    * Product B - Prozac liquid, first authorised in the Community in Denmark on 14 October 1992. Marketing authorisation for Prozac liquid was granted in the UK on 28 October 1992 following an application made by Company E under the hybrid abridged procedure. When making its application, Company E had conceded that Prozac liquid was not essentially similar to Prozac capsules, on account of its different pharmaceutical form, and had submitted additional data intended to show that they were bioequivalent.
    * Product C - The third medicinal product, Fluoxetine liquid, was produced by the applicant.

In October 1999, the applicant applied to the respondent for marketing authorisation for medicinal Product C, Fluoxetine liquid, produced by the applicant. The applicant relied on the abridged procedure under Art 10(1)(a)(iii) of the Directive (on the Community code relating to medicinal products for human use) on the ground that its product was essentially similar to Prozac liquid (Product B).

The MHRA decided that the applicant could not use Prozac liquid as a reference product for the purposes of Art 10(1)(a)(iii) of the Directive because, at the time when the application had been made, medicinal Product B had been authorised in the Community for less than ten years.

The applicant brought an application for judicial review in the High Court against the MHRA's decision, claiming that it was entitled to rely on the data supplied in relation to Prozac liquid. The High Court stayed proceedings and referred the case to the Court of Justice of the European Communities for a preliminary reference regarding the following:

   1. Whether an application for a marketing authorisation for medicinal Product C could validly be made under the first paragraph of Art 10(1)(a)(iii) of the Directive, where the application sought to demonstrate that Product C was essentially similar to another product, Product B, in circumstances where- Product B was related to an original medicinal Product A, in that Product B had been authorised as a "line extension" of Product A, but had a different pharmaceutical form from Product A or was otherwise not "essentially similar" to Product A within the meaning of Art 10(1)(a)(iii)?; and
   2. Whether Product A had been authorised for marketing in the Community for more than the six to ten year period stipulated in Art 10(1)(a)(iii) of the Directive?; and
   3. Whether Product B had been authorised for marketing for less than the six to ten year period stipulated in art 10(1)(a)(iii) of the Directive?

The European Court ruled that:

   1. An application for marketing authorisation for Product C might be made under Art 10(1)(a)(iii) of the Directive where the application sought to demonstrate that Product C was essentially similar to Product B, in circumstances where Product B was a new pharmaceutical form of Product A, and Product A, but not Product B, had been authorised for marketing in the Community for at least the six or ten year period stipulated in the Directive.
   2. The applicant for marketing authorisation for Product C might refer to the pharmacological, toxicological and clinical documentation relating to Product B resulting from the development of the reference Product A, even if Products A and B were not essentially similar on account of their different bioavailability. If an applicant was entitled to refer to the data relating to a variant B which differed from the reference medicinal product in the route of its administration or dose, since the differences in those two factors generally implied that Products A and B were not bioequivalent, it was entitled to do so where the two products were distinguishable only by their different bioavailability, even though the route of administration and dose remained unchanged.
   3. The same reasoning might be followed where the original medicinal product and the variant differed only in that they had a different pharmaceutical form.

If you require further information contact us.

Email: enquiries@rtcoopers.com

© 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.
 

SearchBox

Search Shadow

NewsLetterBox

newsletter Shadow

TestimonialBox

Testimonial Bottom Shadow

testimonial Shadow Middle

More Testimonials

Testimonial Bottom Shadow