FOI release

Freedom of Information request (FOI 22/908)

Published 17 January 2024

FOI 22/908

7th September 2022

Dear

Thank you for your email.

The marketing authorisation for Atimos Modulite 12 micrograms Pressurised Inhalation Solution (PL 08829/0154) was granted via an incoming mutual recognition procedure (MRP) on 29 September 2009 (DE/H/0528/001). As the Reference Member State was Germany for this incoming procedure, we are exempting under S27 of the FOIA (International Relations).

We advise that you contact the German regulator for this information and please find below contact details.

Name

Federal Institute for Drugs and Medical Devices

Address

Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Country

Germany

Phone

+49 228-207-30

Fax

+49 228-207-5207

Email

[email protected]

Website

www.bfarm.de

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre