Debendox Regulatory Approval Access to Information Request (FOI 22/528)

FAITH 22/528

April 11, 2022

Expensive

Thank you for your March 8 email in which you asked: “Could you please provide copies of ALL toxicity/teratogenicity studies that have been performed on the two active ingredients (in combination) dicyclomine and doxylamine (without pyridoxine) for morning sickness medication Debendox? .

Could you also provide information on who is responsible for carrying out all safety assessments of Debendox before it is marketed in the UK. Also, who was responsible for approving Debendox in the UK, and who was the manufacturer in the UK”

The names of MHRA staff who carried out the safety assessments and approved the product in the UK are exempt under section 40 (personal information) and section 38 (health and safety). Article 40 protects personal data the disclosure of which would breach one or more data protection principles. The Agency is convinced that disclosure here would violate the first data protection principle, in particular the requirement of fairness on the grounds that disclosure would not reasonably be expected by the persons mentioned in the information. Section 38 (Health and Safety): The information is withheld under Section 38 of the FOI Act because we believe that its disclosure would or is likely to endanger the physical or mental health, or safety, of any person. Section 38 is a conditional exemption, which means that we considered whether the public interest in disclosing the information outweighs the public interest in not disclosing the information. Examples of public interest arguments would be a major risk to public health or a major breach or procedural irregularity.

Manufacturing sites are exempt under S41 (Information provided in confidence) and S43 (Commercial interests).

Section 41 is an absolute exemption and no consideration of public interest is required except to state that we would consider disclosure of this information an actionable violation.

Section 43 is a conditional exemption and the public interest must be considered. We have considered the public interest and see no public interest argument that outweighs commercial harm in providing information that may assist a competitor in the development of its product and help it overcome regulatory hurdles to get their product to market faster.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in relation to your request, you can request that the decision be reviewed. The review will be conducted by a senior Agency official who was not involved in the original decision.

If you have a question regarding the information provided, please reply to this email.

Cordially

MHRA Customer Experience Center

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