Provision	Legal basis	Scope	Effect
Conditional Marketing Authorization	Article 14(7), Regulation 726/2004 (the centralized procedure regulation), as inserted by Regulation 507/2006 on conditional marketing authorization.	1) Seriously debilitating or life-threatening diseases, 2) public health emergencies, 3) orphan medicinal products (see below)	A marketing authorization may be granted for one year (on a renewable basis) while further studies are conducted, with a view to standard authorization.
Exceptional Circumstances Authorization	Article 14(8), Regulation 726/2004	Where comprehensive safety & efficacy data will never be available because a) the indication is very rare or b) scientific knowledge is insufficient, or c) it would be contrary to medical ethics to collect such information.	Exceptional authorization is granted, subject to safety measures and annual review—unlikely ever to become a ‘standard’ authorization.
Orphan medicinal product designation	Initially Regulation 141/2000 on orphan medicinal products, but this has since been supplemented by a number of regulations—eg 726/2004 on the centralized procedure and regulation 1901/2006 on market exclusivity	Diseases, which are life-threatening or chronically debilitating, and which occur within no more than 5 in 10,000 people in the EU (or where it is otherwise unlikely that marketing would generate sufficient returns) *and* where there is no satisfactory method of diagnosis, prevention or treatment.60	Authorized products have market exclusivity for up to 12 years. Protocol assistance (ie a specific kind of scientific advice for orphan medicines) is provided to help the authorization process.
Compassionate use	Article 83 Regulation 726/2004	Life threatening, long-lasting or seriously debilitating illnesses for which there are no satisfactory authorized therapies and not all patients can enter clinical trials.	Allows the exceptional use of an unauthorized medicinal product outside clinical trials, subject to strict controls.
Accelerated assessment	Article 14(9) Regulation 726/2004	Where the product is of major interest to public health, and in particular for therapeutic innovation.	The timetable for assessment is shortened to 210 days (or 150 days if the relevant committee agrees)
Hospital exemption	Article 28 ATMP Regulation	Non-routine production of an ATMP in a hospital, under the exclusive professional responsibility of a medical practitioner.	This may be authorized by a national competent authority (instead of the European Commission via the EMA) as long as the manufacture is subject to equivalent standards.