Division 6 DOCUMENTATION FOR APPLICATIONS IN EXCEPTIONAL CIRCUMSTANCESF1

When, as provided for in Article 22, the applicant can show that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because:

• 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,

marketing authorisation may be granted subject to certain specific obligations.

These obligations may include the following:

• the applicant shall complete an identified programme of studies within a time period specified by the competent authority, the results of which shall form the basis of a reassessment of the benefit/risk profile,

• the medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital and in the case of a radio-pharmaceutical, by an authorised person,

• the package leaflet and any medical information shall draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects.