Freedom of Information request on the grant approval of Medical Oxygen (FOI 22/582)
Published 14 June 2022
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FOI 22/582
7th April 2022
Dear
Thank you for your email.
Medical Oxygen 100% Medicinal gas, compressed (PL 35326/0008) was authorised by an incoming MRP (BE/H/0202/003/MR) and a Public Assessment Report (PAR) has been published, which is available via the link below:
https://mri.cts-mrp.eu/portal/search/fulltext?term=BE%2FH%2F0202%2F001
Medical Oxygen 100% Medicinal gas, compressed (PL 10414/0002) was authorised by a CoA on 05 March 2013. The original product licence (PL 19156/0091) was authorised on 07 December 2012. A link to the PAR is provided below:
https://mhraproducts4853.blob.core.windows.net/docs/37c18ecb44b2ec7df5bf5944ae80e65afa37d7dc
Medical Oxygen (PL 15929/0005) was authorised on 04 February 1998. As the authorisation of this product predates when MHRA would have been required to publish PARs for newly granted marketing authorisations, there is no PAR published for this product.
Regarding the release of stability data for these products, this information is exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act. Section 41 is an absolute exemption and no consideration of the public interest is required, 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 a consideration of the public interest is required. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing information on the stability testing performed for these products that can used by competitors to overcome regulatory hurdles and inform the product development of other similar products. This decision is in line with the guidance from the Heads of Medicines Agencies/European Medicines Agency guidance on transparency, see page 35 of the below-linked document that indicates that stability data is “commercially confidential information” (CCI):
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Yours sincerely
MHRA Customer Experience Centre