Good pharmacovigilance practices (GVP)

Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568

Adzynma : EPAR - Public assessment report

Combination Products Operational Group: agendas and minutes

Human medicines European public assessment report (EPAR): Tuzulby, methylphenidate hydrochloride, Date of authorisation: 28/02/2025, Revision: 1, Status: Authorised

QRD Form 2 and checklist for the submission of day +25 files - human

QRD Form 2 and checklist for the submission of day +25 files - veterinary

Member states contact points for translations review

Member states contact points for review of national versions of the content of mobile scanning and other technologies

Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products