Conditional marketing authorisation

A conditional marketing authorisation may be granted where, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:
(a) the risk-benefit balance of the medicinal product is positive;
(b) it is likely that the applicant will be in a position to provide the comprehensive clinical data;
(c) unmet medical needs will be fulfilled;
(d) 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.
In emergency situations, a conditional marketing authorisation may be granted, also where comprehensive pre-clinical or pharmaceutical data have not been supplied.

In the context of conditional marketing authorisation ‘unmet medical needs’ means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the Community or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.

By way of specific obligations, the holder of a conditional marketing authorisation shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is positive and providing the additional data.
In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.
The specific obligations referred and the timeframe for their completion shall be clearly specified in the conditional marketing authorisation and made publicly available.
After its period of validity of one year the conditional marketing authorisation may be renewed annually.
The application for renewal shall be submitted to the Agency at least six months before the expiry of the conditional marketing authorisation, together with an interim report on the fulfilment of the specific obligations to which it is subject.
The Committee shall assess the application for a renewal, on the basis that the risk-benefit balance is to be confirmed, taking into account the specific obligations contained in the authorisation and the timeframe for their fulfilment, and shall formulate an opinion as to whether the specific obligations or their timeframes need to be retained or modified.
The Agency shall ensure that the opinion of the Committee is given within 90 days following receipt of a valid renewal application. That opinion shall be made publicly available.
Once a renewal application has been submitted in accordance with paragraph 2, the conditional marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 10 of Regulation (EC) No 726/2004.
Cf. marketing authorisation

Last update: 7 June 2023

Source: Commission Regulation No 507/2006 of 29 March 2006