Commission decisions

Article 107i procedures (Urgent Union procedure) - Directive 2001/83/EC

This type of procedure is triggered when a Member State or the European Commission consider that urgent action is necessary because of a safety issue. Situations that fall under this procedure include consideration for suspension or revocation of the marketing authorisation for a medicine, the prohibition of supply of a medicine or major changes to the marketing authorisation such as deletion of indications, reduction of the recommended dose or new contraindications.

Article 31 Referral - Directive 2001/83/EC

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Article 30 Referral - Directive 2001/83/EC

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Article 29 Referral paediatrics or 29(4) - Directive 2001/83/EC or Article 13 Referral - Regulation 1234/2008/EC or Article 20 Referral - Regulation 726/2004/EC

General information on the different types of referrals can be found on the website of the European Medicines Agency (EMA).

PSUSA (PSUR single assessment) - Article 107e of Directive 2001/83/EC

PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. EMA and national competent authorities assess information in PSURs to determine if there are new risks identified for a medicine and/or if its risk-benefit balance has changed, which may lead to further actions (e.g update of the productinformation). PSURs submitted in accordance with the EURD list are subject to the EU PSUR single assessment (PSUSA) procedure. During a PSUSA procedure PSURs of medicines containing the same active substances or combinations, even if they are subject to different marketing authorisations and are authorised in different EU Member States will be assesesd. This aims to harmonise and strengthen benefit-risk review of medicines across the European Economic Area. If at least one centrally authorised medicinal product is included in a PSUSA procedure, the European Commission adopts a Commission Decision.

Further information on Periodic safety update reports can be found on the website of the European Medicines Agency (EMA) and under FAQ Pharmacovigilance.

Implementation of Commission Decisions in Austria

All marketing authorisation holders with nationally authorised medicinal products or MRP/DCP medicinal products with Austria as RMS who are concerned by a Commission Decision (under Articles 30, 31, 107e and 107i of Directive 2001/83/EC) are requested to submit a variation for the implementation of the Commission Decision.

The wordings for Referrals and PSUSAs will be published on the BASG homepage (PV-wordings)

When submitting the variation, please state the following in accordance with the BASG letter in the coverletter ('PHV-Issue: XYZ -PSUSA/XXXXXXXXXX/JJJJMM' and the transaction number (PHV-XXXXXXXX-A-JJMMDD(-EUIM))). If other text-relevant procedures have been submitted, this should be stated in the cover letter.

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