SPCs and PILs for discontinued products in the last eight years

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

I would be grateful if you could provide an excel sheet of medicines that have been discontinued in the UK in the last eight years. Please include the brand name, molecule name, dose form, strength, approval date, discontinuation date, date of expiry of sunset clause if applicable.

In addition please provide the SPC and PIL for each of these products.

Yours faithfully,

Vijay

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

FOI 19/107

Dear Vijay,

Thank you for your email of 12 December where you have asked "I would be grateful if you could provide an excel sheet of medicines that have been discontinued in the UK in the last eight years. Please include the brand name, molecule name, dose form, strength, approval date, discontinuation date, date of expiry of sunset clause if applicable" and " In addition please provide the SPC and PIL for each of these products"

Please find attached the list of cancelled licences.

We are exempting your request for the Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) for each of these products under Section 12 of the Freedom of Information Act (unreasonable use of resources).

Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. We consider that Section 12 applies in this instance because of the complexity of fees and the number of licences involved. We are not able to provide an estimated figure, nor is it 'information held' by the agency as defined in the Act. Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that Section 12 could still apply.
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: [MHRA request email]. Alternatively, you may write to:

The Communications Division
10-N, MHRA
10 South Colonnade
Canary Wharf
London E14 4PU
UK

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

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

Yours sincerely,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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