S.L. 458.34 Art. 17Exceptional circumstances.

(a) In exceptional circumstances and following consultation with the applicant, the marketing authorisation may be granted subject to certain conditions, in particular relating to the safety of the medicinal product, notification to the Authority of any incident relating to its use, and action to be taken. The marketing authorisation may be granted only when the applicant can show that he is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, for objective, verifiable reasons and it should be based on one of the grounds set out in Schedule I. Continuation of the marketing authorisation shall be linked to the annual reassessment of these conditions.

(b) After the granting of a marketing authorisation, the Licensing Authority may impose an obligation on the marketing authorisation holder:

(i) to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. If the same concerns apply to more than one medicinal product, the Authority shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;

(ii) to conduct a post-authorisation efficacy study when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly. The obligation to conduct the post-authorisation efficacy study shall be based on the guidelines or Regulations published by the Commission pursuant to Article 22b of Directive 2001/83/EC as amended, while taking into account the scientific guidance referred to in Article 108a of Directive 2001/83/EC as amended. The imposition of such an obligation shall be duly justified, notified in writing, and shall include the objectives and timeframe for submission and conduct of the study. The Authority shall provide the marketing authorisation holder with an opportunity to present written observations in response to the imposition of the obligation within a time limit which it shall specify, if the marketing authorisation holder so requests within thirty days of receipt of the written notification of the obligation. On the basis of the written observations submitted by the marketing authorisation holder, the Licensing Authority shall withdraw or confirm the obligation. Where the Licensing Authority confirms the obligation, the marketing authorisation shall be varied to include the obligation as a condition of the marketing authorisation and the risk management system shall be updated accordingly.

(c) The marketing authorisation holder shall incorporate any conditions referred to in paragraphs (a) and (b) and in regulation 16(b), in his risk management system.

(d) The Member States shall inform the Agency of the marketing authorisations that they have granted subject to conditions pursuant to paragraphs (a) or (b) or in regulation 16(c).