Make a submission – medicines for human use

Request for pre-submission meeting for MIA DOCX : 68 KB | 13/03/2023 Application for register for exemption DOCX : 106 KB | 02/02/2023 Directive 2022-642 Justifiable case template for inclusion of UK(GB) sites in regulatory submissions for Ireland DOCX : 70 KB | 17/08/2022 Request for a derogation under Directive 2022-642 DOCX : 115 KB | 21/06/2022 Suspected unexpected serious adverse reaction report (SUSAR) form for investigator led trials DOCX : 110 KB | 08/06/2022 Annual communication to registration of manufacturer importer or distributor of active substances DOCX : 112 KB | 24/04/2022 Variation or immediate notification of change to registration DOCX : 108 KB | 07/03/2022 Request for classification of a human health product DOCX : 110 KB | 16/02/2022 Application to vary a wholesale distribution authorisation DOCX : 122 KB | 31/01/2022 Application to withdraw an authorisation licence approval or registration DOCX : 110 KB | 28/01/2022 Application for registration of manufacturer importer or distributor of active substances DOCX : 111 KB | 28/01/2022 National Submission Form for DHPCs and Communication Plans for MAHs DOCX : 70 KB | 24/01/2022 Report of medicinal product shortage affecting the Irish market from patients and healthcare professionals DOCX : 104 KB | 01/09/2021 Report of medicinal product shortage affecting the Irish market from wholesale distributors and manufacturers DOCX : 104 KB | 01/09/2021 Regulatory submission query form DOCX : 100 KB | 26/04/2021 Notification of withdrawal of authorisations or certificates for human medicines DOCX : 103 KB | 15/04/2021 Notification of marketing status of human medicines DOCX : 105 KB | 15/04/2021 Certificate of free sale (medicinal products) DOCX : 25 KB | 01/10/2020 Application for a change to labels and or patient information leaflets not connected with changes to the SmPC DOCX : 107 KB | 14/07/2020 Application form B for transfer before authorisation DOCX : 102 KB | 18/12/2019