Notifying EMA of changes to contact persons (veterinary medicines)

Applicants and marketing authorisation holders for veterinary medicines must notify the European Medicines Agency (EMA) of any upcoming changes to contact persons specified in the application form for initial marketing authorisation.

Applicants and marketing authorisation holders for veterinary medicines must notify EMA of any upcoming changes to contact persons specified in the application form for initial marketing authorisation.

This enables EMA to update its databases.

For more information on EMA's work on post-authorisation for veterinary medicines, see:

• Post-authorisation (veterinary medicines)
   

How to notify EMA

The IRIS industry coordinator should submit via the IRIS portal any changes to the following contact persons specified in the application form for the initial marketing authorisation (sections 2.4.1, 2.4.3 and 2.5.1.1):

• Pre-submission product contact
• Contact person at the MAH address to be contacted for the courier delivery of the Commission Decision documents (referred to in section 2.4.1 of the application form for initial marketing authorisation application). The address given must correspond to the official address of the MAH and the telephone number must be from the same country. It will be used for delivery of all Commission decisions. As this contact person is used by the European Commission for notification of Commission decisions to the MAH, this information should be kept up to date and any changes (including during the post-authorisation phase) notified to EMA promptly
• Person / company authorised for communication on behalf of the applicant during the initial marketing authorisation application in the Union (referred to in section 2.4.2 of the application form). This contact is only used until the marketing authorisation is granted (i.e. up to when the Commission decision is received)
• Person / company authorised for communication after authorisation (referred to in section 2.4.3 of the application form). This contact will be used after the marketing authorisation is granted (i.e. from when the Commission decision is received)
• Contact person in the European Economic Area (EEA) for product defects and recalls, established in accordance with (or in the context of) Articles 44 and 45 of Commission Implementing Regulation (EU) 2025/2091

The IRIS industry coordinator should submit the changed mentioned above via the IRIS portal. They should do so by selecting the tab “Products”, followed by the sub-tab "Authorisation Products - Contacts - Industry".

For more information, see:

IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants

Reference Number: EMA/444925/2018 Version 3.14

IRIS guide to registration and RPIs

Reference Number: EMA/444925/2018 Version 2.19 Summary:

Preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.

You need an EMA account to use IRIS. If you do not have one, you can create one via the EMA Account Management website.

For products with ongoing initial application outside of IRIS - inform the product lead via email after you have submitted these updates in IRIS. This is required until the product is authorised and all post-authorisation activities are moved in IRIS. 

With regard to the qualified person in the EEA for pharmacovigilance (QPPV) referred to in section 2.4.4 of the application form, marketing authorisation holders should notify any changes via a variation not requiring assessment (VNRA), classification C.1.

Page update history

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The tracking of updates begins in June 2026.

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15 June 2026

• Updates across the page to reflect changes in informing EMA of changes to centralised product contact persons