Introduction of reporting of serious undesirable effects: a responsible person will have an obligation to notify serious undesirable effects to competent national authorities.

In April 2008, an Irish citizen asked EMA for access to documents containing details of all suspected serious adverse reactions relating to an anti-acne drug.

EMA refused his request, arguing that the EU rules on access to documents did not apply to reports concerning suspected serious adverse reactions to drugs.

3. The marketing authorisation holder shall ensure that all suspected serious unexpected adverse reactions, human adverse reactions and any suspected transmission via a veterinary medicinal product of any infectious agent occurring on the territory of a third country are reported promptly in accordance with the guidelines referred to in Article 77(1), so that they are available to the Agency and the competent authorities of the Member States in which the veterinary medicinal product is authorised, and no later than 15 days following the receipt of the information.

3. The marketing authorization holder shall ensure that the suspected serious and unexpected adverse reactions and human adverse reactions, occurring in the territory of a third country, are reported immediately in accordance with the guidance referred to in Article 77(1), so that they are available to the Agency and to the competent authorities in the Member State(s) where the veterinary medicinal product is authorized, and in no case later than 15 calendar days following the receipt of the information.

- "serious unexpected adverse reaction " means an adverse reaction which is both serious and unexpected.