7. Types of Marketing Authorisation Applications

A hybrid application differs in certain cases, where results of non-clinical tests or clinical trials are required. These applications rely in part on the results of non-clinical tests and clinical trials for a reference product, and partly on new data.

This is necessary in three cases:

• where the strict definition of ‘generic medicine’ is not met.
• where the bioavailability studies cannot be used to demonstrate bioequivalence.
• where there are changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration of the generic product compared to the reference medicine.

At the time of submission of a generic/hybrid application, the period of data exclusivity* of the reference medicine must have expired in order to allow the applicant to rely on the dossier of the reference medicine. Data exclusivity is not less than eight years after authorisation in the EU.

In addition, an authorised generic medicine shall not be placed on the market until ten years after the initial authorisation of the reference product. The period of ten years from initial authorisation of the reference product provides a period of market protection** for the reference product.

* This period provides a time of so-called “data exclusivity” to the reference product, which means that eight years from the initial authorisation of a medicine the marketing-authorisation holder benefits from the exclusive rights to the results of preclinical tests and clinical trials on the medicine. After this period, the marketing authorisation holder is obliged to release this information to companies wishing to develop generic versions of the medicine.

** The protection of an approved medicine against competition from generic medicines that extends beyond the protection conferred by data exclusivity. During this period, applications for generics can be accepted and authorised, but the generic medicines cannot be placed on the market.

Legal basis: Article 10 (3) of Directive 2001/83 (EC) and Article 6 of Regulation (EC) 726/2004