S.L. 458.35 Art. 15Recording, reporting and assessment of pharmacovigilance data.

Marketing authorisation holders shall record all suspected adverse reactions in the Community or in third countries which are brought to their attention, whether reported spontaneously by patients or healthcare professionals, or occurring in the context of a post-authorisation study. Marketing authorisation holders shall ensure that those reports are accessible at a single point within the Community:

Provided that that by way of derogation from the above, suspected adverse reactions occurring in the context of a clinical trial shall be recorded and reported in accordance with Directive 2001/20/EC.