Module 6

04 October 2024

Applicant claims: Conditional and Exceptional MAs

Regulatory pathways for granting marketing authorisations

”Full”/”Normal” MA

Conditional MA

MA under exceptional circumstances

Regulation Reg (EC) No. 726/2004 Art. 6, 8 Dir 2001/83/EC

Art. 14(7) of Reg (EC) No 726/2004 Art. 4 of Commission Reg (EC) No. 507/2006 Comprehensive clinical data have not yet been supplied , but all the following requirements are met: - the risk-benefit balance is positive; - it is likely that the applicant will be able to provide the comprehensive clinical data ; - unmet medical needs will be fulfilled; - the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required

Art. 14(8) of Reg (EC) No. 726/2004

Data requirements

Full dossier; comprehensive data on the efficacy and safety

Comprehensive data cannot be provided due to specific reasons foreseen in the legislation (Annex I, Part II, Directive 2001/83/EC): − The indications for which the product in question is intended are encountered so

rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or

− In the present state of scientific knowledge, comprehensive information cannot be provided, or − It would be contrary to generally accepted principles of medical ethics to collect such information.

It will normally never be possible to assemble a full dossier

Not intended to remain conditional

Data comprehensiveness

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An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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Applicant claims : +1 year protection

Extension Data Exclusivity/Marketing Protection

New indication representing a significant clinical benefit versus existing therapies • +1 year protection under art 14(11) Reg 726/2004 for CAP and Art 10(1) of Directive 2001/83/EC for NAP

New indication for Well Established Substance

• +1 year data exclusivity under Art 10(5) of Directive 2001/83/EC

Change of legal status based on non clinical and clinical tests

• +1year data exclusivity under Art 74 (a) of Directive 2001/83/EC

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An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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