FOI release

Freedom of Information request on new MAA's on Lidocaine (FOI 21/1213)

Published 26 May 2022

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FOI 21/1213

19th November 2021

Dear,

Thank you for your email.

Regarding your request for information on Lidocaine:

  1. Have new MAA’s been submitted where UK(NI) is a CMS.
  2. Have new MAAs been submitted for stand alone National licences.
  3. If yes to points 1 or 2 above, can MHRA advise which API form is used for these generic / hybrid applications and also if possible who the applicant is.

MHRA neither confirms nor denies that it holds information falling within the description specified in your request. The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act. This should not be taken as an indication that the information you requested is or is not held by the department.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in alerting competitors to whether a rival product is trying to come onto the market or not. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity

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.

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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 Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

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