Make a submission – medicines for human use

Application for a Parallel Import Licence - Human Medicines

DOCX : 73 KB | 11/07/2023

Quality defect reporting form for MAHs, manufacturers and wholesalers

DOCX : 78 KB | 05/07/2023

Batch-specific requests

DOCX : 108 KB | 28/05/2023

Request for pre-submission meeting for MIA

DOCX : 68 KB | 13/03/2023

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

Notification of marketing status of human medicines

DOCX : 105 KB | 15/04/2021

Notification of withdrawal of authorisations or certificates for human medicines

DOCX : 103 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

Certificate of a pharmaceutical product (English)

DOCX : 190 KB | 16/03/2019