Human Medicines - Referrals
List of Referrals - Article 107 procedures
Background
Article 107 of Directive 2001/83/EC as amended states that ‘Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, revoked or varied […] it shall forthwith inform the Agency, the other Member States and the marketing authorization holder.
Once informed, the CHMP prepares an opinion with a recommendation on what should be done, on the basis of which the Commission will issue a decision.
These procedures are often for an active substance, rather than for a single medicine.
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European Medicines Agency - Human Medicines - Referrals - Article 107
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