FOI release

Freedom of Information request on the information in relation to the clinical and non-clinical particulars of Nicorette Quickmist 1mg/spray mouthspray PL 15513/0357 and Nicorette Nasal Spray 10ml PL 15513/0180 (FOI 21/1151)

Published 26 May 2022

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FOI 21/1151

12th November 2021

Dear,

Thank you for your email, dated 20 October 2021, in which you requested ‘Information related to their application review………, most specifically in relation to the clinical and non-clinical particulars of these products.’ for the below products:

• Nicorette Quickmist 1mg/spray mouthspray PL 15513/0357

• Nicorette Nasal Spray 10ml PL 15513/0180

In response to your request concerning Nicorette Quickmist 1mg/spray mouthspray (PL 15513/0357), please refer to the Public Assessment Report on the MHRA website, which is accessible via the below electronic link:

https://mhraproducts4853.blob.core.windows.net/docs/35a47461661dcc861995b1f903f35822e7e76221.

A product licence for Nicorette Nasal Spray 10 mg/ml (PL 15513/0180) was granted on 01 February 2008 to McNeil Limited, following a series of change of ownership (COA) procedures of the original product licence Nicorette Nasal Spray 10 mg/ml (PL 00022/0141). Nicorette Nasal Spray 10 mg/ml (PL 00022/0141) was granted to Pharmacia Laboratories Limited on 17 May 1994. Therefore, in response to your request for information in relation to Nicorette Nasal Spray 10 mg/ml (PL 15513/0180), we are providing the attached MHRA assessment reports extracted from the Committee on Safety of Medicines (CSM) paper (CHM meeting held in January 1994) concerning consideration of the original application for Nicorette Nasal Spray 10 mg/ml (PL 00022/0141). Please note that:

  1. the documentation is historical (having been prepared at least 28 years ago) and variation applications may have been submitted subsequently to update some of the information included.

  2. the documentation has been redacted under Section 40 (Personal Information), Section 41 (Information given in confidence) and Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act.

Disclosure of information subject to Section 40 (Personal information) would be an infringement of personal data. Section 40 (Personal information) is an absolute exemption and no consideration of the public interest is required.

Section 41 (Information given in confidence) is an absolute exemption, and no consideration of the public interest is necessary, except to state that the release of this information withheld under this section of the FOI Act would be considered an actionable breach by the MHRA.

We have redacted some parts of the attached documentation under Section 43 (Commercial Interests) of the FOI Act because the release of all, or part of, the information would, or would be likely to, cause harm to the third party’s commercial interests. The exemption is to safeguard the commercially sensitive information/commercial enterprise. In this case, release of information would enable the competitors to overcome several regulatory hurdles in the research and development of their own products. This exemption is conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. We have considered the balance of the public interest when applying this exemption. In this case, we have not identified any issues which would benefit the public, as a whole, by being brought to their attention.

We now consider this FOI request closed. If you have a query about this letter, please contact the MHRA FOI Licensing mailbox using the email address listed below.

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 2 months of the date you receive this response and addressed to: info@mhra.gov.uk, quoting reference FOI 21/1151.

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, and Cheshire, SK9 5AF.

Yours sincerely,

The FOI Licensing Team

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