Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Limits of "Essential Similarity" regarding abridged marketing Authorizations ***

Julia Tillkes (Abschlußjahr: 2003)

Directive 2001/83/EC provides the basis for applications for marketing authorisation regarding medicinal products in the EU.

Article 8 of the directive requires results submitted from pharmacological and toxicological tests and clinical trials. However, by Article 10 of Directive 2001/83/EC, such results need not to be provided by an applicant where the medicinal product is essentially similar to a product which has been authorised within the EU for more than 6 or 10 years, depending on the country, and is marketed in the Member State for which the application is made.

However, the law does not define what is meant by "essentially similar". Thus, interpretations of the meaning of this term were and are still made by judgements of the European Court of Justice (ECJ).

Following an interpretation delivered by the ECJ in its Generics judgement of 03.12.1998 a medicinal product is essentially similar to an original medicinal product, where it satisfies the criteria of having the same qualitative and quantitative composition in terms of active principles, the same pharmaceutical form and of being bioequivalent. Even so, it will not be essentially similar if it is apparent in the light of scientific knowledge that it differs significantly from the original product as regards safety or efficacy.

But it is still not defined by current law what is meant by "the same active principle" and "the same pharmaceutical form".

The proposed amendment to Directive 2001/83/EC, published on June 12, 2003, is helpful with respect to the regulations of abridged marketing authorisations. It addresses the unresolved issues in the current directive resulting in cases that were and still have to be judged by the ECJ.

In this proposed amendment the term "essentially similarity" is dropped and the controversial issues falling under its definition have been resolved. So it is clearly stated what is meant by "the same active principle" as well as "pharmaceutical form". Also the need for bioequivalence studies is clearly defined.

So the proposal states that if the generic differs from the reference product in terms of active substance or pharmaceutical form, appropriate bridging data will have to be submitted.

The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy.

The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form.

Moreover, generic applicants will be able to refer to well-known products without having to perform bioavailability studies, if he can demonstrate, that the product meets the relevant criteria as defined in the appropriate detailed guidelines.

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