CRED 8 Presentations

01/07/2024

Module 1.5.3 (Extended) Data / Market Exclusivity

When MAH/applicant wishes to claim (additional) data / market exclusivity when applying for a new indication or change in classification, based on the following legal provisions: • Article 10(1) of Directive 2001/83/EC and Article 14(11) of Regulation 726/2004 , the 10- year period of marketing protection may be extended by one year in the event of authorisation of new therapeutic indications representing a significant clinical benefit in comparison with existing therapies. • Article 10((5) of Directive 2001/83/EC a non-cumulative period of one year of data exclusivity may be granted for a new indication for a well-established substance , provided that significant pre-clinical or clinical studies are carried out in relation to the new indication. • Article 74a of Directive 2001/83/EC where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials , the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant or marketing authorisation holder for a change of classification of the same substance for one year after the initial change was authorised.

The Organisation for Professionals in Regulatory Affairs

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Module 1.5.4 Exceptional Circumstances

Article 22 of Directive 2001/83/EC and Article 14(7) of Regulation (EC) No 726/2004

An authorisation may be granted in exceptional circumstances subject to a requirement for the applicant to introduce specific procedures, in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken. Such an authorisation may be granted only for objective, verifiable reasons and must be based on one of the grounds set out in Part II.6 of the Annex I to Directive 2001/83/EC.

The Organisation for Professionals in Regulatory Affairs

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