FOI release

Freedom of Information request about Camcolit 400 mg, controlled release Lithium Carbonate and Priadel 400mg Prolonged Release Tablets (FOI-21-432)

Published 28 May 2021

Thank you for your email.

Regarding your request for the in vitro dissolution data for Camcolit 400 mg, controlled release Lithium Carbonate (PL 41871/0003) and Priadel 400mg Prolonged Release Tablets (lithium carbonate, PL 50301/0002), this information is exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.

Section 41 is an absolute exemption and there is no requirement to consider the public interest, except to state that we would consider the release of this information to be an actionable breach of confidence.

Section 43 is a qualified exemption and so 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 releasing information that can be used by competitors to inform their own product development and help them overcome regulatory hurdles to get their product to market quicker. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.

Regarding your request for the lithium plasma absorption profiles for these products, it should be noted that the product licence for Camcolit 400 mg, controlled release Lithium Carbonate (PL 41871/0003) is a Change of Authorisation Holder (CoA) from an original licence that was granted in 1977 (PL 00322/0015). Further, the product licence for Priadel 400mg Prolonged Release Tablets (PL 50301/0002) is a Change of Authorisation Holder (CoA) from an original licence that was granted in 1985 (PL 00357/5000R). Because of the age of these products, any documents that we hold are in paper copy at our archive. Unfortunately, due to the current lockdown guidance, we are unable to access paper records from our archive. Therefore, we are unable to respond to this part of your request to confirm whether we hold any information on the plasma absorption profiles for these products.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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]

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