Make a submission – medicines for human use

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

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 : 119 KB | 31/01/2022

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

Regulatory submission query form

DOCX : 100 KB | 26/04/2021

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

Certificate of a pharmaceutical product (English)

DOCX : 190 KB | 16/03/2019

Application for a variation to a parallel import licence

DOCX : 37 KB | 04/02/2017

Certificate of a pharmaceutical product (French)

DOCX : 30 KB | 06/10/2016

Certificate of a pharmaceutical product (Spanish)

DOCX : 32 KB | 06/10/2016

Application for registration of broker of finished medicinal products for human use

DOCX : 114 KB | 29/07/2016

Application for waiver from written confirmation requirement

DOCX : 62 KB | 30/06/2016