FOI release

Freedom of Information request on the marketing authorisation of Nicorette 6 mg FruitFusion gum (FOI 22/574)

Published 14 June 2022

FOI 22/574

8th April 2022

Dear

Thank you for your email.

A summary of MHRA’s assessment of the data required to grant a marketing authorisation is provided in the PARs that are published on the MHRA website. There are a lot of PARs for Nicorette available on the MHRA website, a link to these is provided below:

https://products.mhra.gov.uk/search/?search=Nicorette&page=1&doc=Par&rerouteType=0

For example, the PAR for Nicorette Fruitfusion Gum (PL 15513/0381, linked below) contains MHRA’s assessment of the clinical data for this application.

https://mhraproducts4853.blob.core.windows.net/docs/852a76c49582ebaec0e7f6e820331fd5e19a2ee8

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

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]

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