Conditional marketing authorization

Conditional Marketing Authorization

The scope of conditional marketing  is

• Seriously debilitating or life-threatening diseases
• Emergency threats (WHO, EU Commission)
• Orphan medicinal products

A Conditional MA may be granted when, although comprehensive clinical data have not been provided, all of the following requirements are met:

• Benefit/Risk balance is positive
• It is likely that comprehensive clinical data will be provided
• Unmet medical needs will be fulfilled
• Benefit to public health of immediate availability outweighs risks that additional data are still required

Conditional MA will be subject to specific obligations to complete ongoing studies, or to conduct new studies with a view to confirming the positive Benefit/Risk balance. Applicant to provide reassurance on the feasibility and quality of additional studies to be performed

Conditional MA only for initial MA Applications, not for variations (supplements)

Conditional MA valid for one year, renewable

Reference: Guideline on Conditional Marketing Authorization