Freedom of Information request about the quantities of Sorbitol (E420), sodium methyl hydroxybenzoates and propylhydroxybenzoates in the product Glycopyrronium Oral Solution (FOI-21-336)
Published 28 May 2021
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Regarding the quantities of Sorbitol (E420), sodium methyl hydroxybenzoates and propylhydroxybenzoates in the product Glycopyrronium Oral Solution 1mg/5ml (PL 41344/0010), the quantitative compositions of all excipients in medicinal products are 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 no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.
Section 43 is a qualified exemption and 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 publishing information that can be used by rival pharmaceutical companies to aid their own product development, overcome regulatory hurdles and get their product on the market quicker. Examples of public interest arguments would be a major public health risk, or a major procedural failure or irregularity.
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Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU