Conditional marketing authorisation

A conditional marketing authorisation is a centralised authorisation granted on the basis of less comprehensive clinical data than normally required, where the benefit of the immediate availability of the medicinal product outweighs the risk inherent in the missing data. It is provided for by Regulation (EC) No 726/2004 and further specified by Commission Regulation (EC) No 507/2006. The holder undertakes to complete the data within set time limits, and the authorisation is intended to become a standard authorisation.

Conditions for conditional authorisation

Conditional authorisation is reserved for medicinal products intended for the treatment, prevention or diagnosis of seriously debilitating or life-threatening diseases, for medicinal products to be used in emergency situations in response to public health threats and for orphan medicinal products. Four cumulative conditions must also be met.

• The benefit/risk balance of the medicinal product is positive.
• The applicant is likely to be able to provide comprehensive clinical data.
• The medicinal product fulfils an unmet medical need.
• The public health benefit of its immediate availability outweighs the risk inherent in the fact that the data are still incomplete.

Regime of the authorisation

A conditional authorisation is valid for one year and renewable annually. It is subject to specific obligations, such as completing ongoing studies or conducting new ones, compliance with which is reviewed at each renewal. The summary of product characteristics and the package leaflet state its conditional nature. Once the obligations have been fulfilled and the comprehensive data confirm the benefit/risk balance, the authorisation is converted into a standard authorisation, valid for five years. It is distinct from an authorisation under exceptional circumstances, granted where comprehensive data can never be obtained.

Consequences for protection

A conditional authorisation is a marketing authorisation in its own right, granted under the centralised procedure. Its date therefore triggers data protection and market protection, and it is the first authorisation to be taken into account in calculating the duration of a supplementary protection certificate. An earlier authorisation shortens the interval between the patent filing and the authorisation, and reduces the duration of the certificate accordingly. The holder must take this into account when choosing between a conditional application and waiting for comprehensive data.

Key points

A conditional authorisation makes a medicinal product that meets an unmet need in a serious disease available to patients sooner, in return for obligations to complete the data. Valid for one year and renewable, it is intended to become a standard authorisation. Its date counts in full for regulatory protection and for the supplementary protection certificate. This effect should be built into the product’s protection timetable, and the specific obligations should be followed rigorously, since failure to comply may lead to suspension of the authorisation.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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