Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA - template

Sep 19, 2026

Upload by Tawan

Request form for the exchange of information between competent authorities in the EEA concerning marketing authorisation holders (MAHs) or manufacturing authorisation holders. The document provides a union request format with adoption and entry-into-force dates, revision reasoning, and version notes. It includes sections to identify the requesting and recipient competent authorities, contact details, MAH/QPPV/PSMF and manufacturer information, and a structured table to specify the information being requested, alongside a corresponding reply form.

LanguageEnglish

CategoryForms

FormatPDF

Pages3

Reading Time1 min

AccessFree to download

Union format for a request form for the exchange of information

Title

Date of adoption

Date of entry into force

Supersedes

Reason for revision

Notes

Last publication date

Document version

Requesting and recipient competent authority details

Requesting competent authority

Recipient competent authority

Request for exchange of information

MAH/QPPV/PSMF and manufacturer identification

Information requested

Reply form in response to a request

Confirmed information and responsible officer signature

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Health systems, medical products and innovation Medical products: quality, safety, innovation Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA Table of contents: 1. Union format for a request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA Title Date of adoption Date of entry into force Supersedes Reason for revision Notes Last publication date: Document version Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA May 2012 By 2 January 2013 New New Not applicable 1 August 2024 1 Request form for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA The templates below were developed in order to facilitate exchange of information between the competent authorities in EEA where there are no established procedures or systems (e.g. EudraGMDP) for the exchange of information | Reference no. : | No. of pages/No. of attachments: | Date: | | --- | --- | --- | Requesting Competent Authority | Competent Authority/ Country | | | --- | --- | | Address/phone/fax | | | Contact Person | | | Email of Contact Person | | Recipient Competent Authority | Competent Authority/ Country | | | --- | --- | | Address/phone/fax | | | Contact Person | | | Email of Contact Person | | Request for Exchange of Information on [complete as appropriate] | MAH-Address/phone/fax/Email | | | --- | --- | | QPPV/ PSMF site – Address/phone | | | Medicinal Product/dosage form/strength/INN/MA | | | Manufacturer
Address/phone/fax/Email | | | Information requested | | Reply form in response to a request for the exchange of information on marketing authorisation holders or manufacturing authorisation holders between the competent authorities in the EEA As requested by the competent authority of on ....../ / (Original [Ref. no .............](Ref. no .............). ), the competent authority of confirms the following information: The MAH and/ or QPPV/PSMF or the Manufacturer (delete as appropriate) ………………………………………………………………………………………………………………………………………………………………………. (Medicinal Product/dosage form/strength/INN/MA) Address ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………………………… Name and signature of a responsible officer of the reporting competent authority: Date:

FAQs

What is the purpose of this request form?

It facilitates the exchange of information between competent authorities in the EEA when established procedures or systems for exchanging information are not available.

Which parties and roles can be covered by the exchange request?

The request can cover a marketing authorisation holder (MAH) and/or QPPV/PSMF site, or the manufacturer, as indicated by the completed fields (with wording for deleting as appropriate).

What information must be provided in the request?

The form collects identification and contact details for the requesting and recipient competent authorities, as well as MAH/QPPV/PSMF site and medicinal product or manufacturer data, followed by a dedicated section to specify the information requested.

Sep 19, 2026

Upload by Tawan