Freedom of Information request on the reference products used for each authorised marketing authorisation (FOI 22/046)
Published 31 May 2022
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FOI 22/046
3rd February 2022
Dear,
Thank you for your email.
MHRA does not hold information on the reference products used for each authorised marketing authorisation in a searchable format. However, the PARs for any marketing authorisation granted via the national or decentralised procedure where the UK was Reference Member State (RMS) after 31 October 2005 are available on the MHRA website. The PARs do state the legal basis and what reference product was used for each product.
For marketing authorisations granted via the centralised procedure, you are advised to refer to the ePARs on the EMA website.
For marketing authorisations granted where the UK was a Concerned Member State, you are advised to refer to the PAR on the Heads of Medicines Agencies MRI index or the RMS website.
Regarding your request for information on marketing authorisation applications received by the agency that have not been granted, 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.
If you have any queries, 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: info@mhra.gov.uk
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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000