Article 101 of Directive 2001/83/EC requires Member States to take all appropriate measures to encourage health care professionals to report suspected adverse reactions to the competent authorities. Member States can impose specific reporting requirements on health care professionals, particularly where reporting is a condition of the marketing authorisation.
Once notified of suspected serious adverse reactions, Article 105 requires Member States to ensure that they are brought to the attention of the Agency, the other Member States and the marketing authorisation holder within 15 days, using the Agency's data-processing network. Where, following an evaluation of adverse reaction reports, a Member State decides that a marketing authorisation should be varied, suspended or withdrawn, Article 107 imposes an obligation to notify the Agency and the marketing authorisation holder immediately. In urgent cases, a Member State may suspend the marketing of a medicinal product, on condition that the Agency is informed the following working day at the latest.
EUROPEAN PHARMACOVIGILANCE FOR CENTRALLY AUTHORISED MEDICINAL PRODUCTS-REGULATION (EEC) NO. 2309/93
Article 51c of Regulation (EEC) No. 2309/93 makes the Agency responsible for the co-ordination of the supervision of medicinal products which have been authorised within the Community and for providing advice on the measures necessary to ensure the safe and effective use of these products. Chapter 3 of Regulation (EEC) No. 2309/93 deals specifically with pharmacov-igilance.
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