Freedom of Information request on a clinical overview for Melatonin AGB 1 mg tablets (FOI 21-425)
Published 28 June 2021
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6th May 2021 FOI 21/425
Dear
Thank you for your email.
Regarding your request for a copy of the clinical overview for Melatonin AGB 1 mg tablets (PL 52497/0001).
This product licence was granted by an incoming Mutual Recognition Procedure (MRP), with Sweden as the Reference Member State (RMS - SE/H/2048/001/MR)
We consider that disclosure of this information is likely to damage the MHRA’s relationship with another regulator or country, and thus could damage the UK’s interests abroad. Section 27 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from releasing documentation related to this product. However, we consider that the public interest will be better served by not releasing the information as this product is granted by Sweden, the data submitted would need to be considered by the Swedish medicines authority for release.
We advise that you contact the Sweden medicines authority directly for this information.
Name Medical Products Agency Address Dag Hammarskjölds väg 42 / Box 26 SE – 751 03 UPPSALA Country Sweden Phone +46 18 17 46 00 Fax +46 18 54 85 66 Email registrator@mpa.se Website www.lakemedelsverket.se
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: 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 Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU