Division 4 Exchange of inspection reports

Upon reasoned request by a Party, the relevant inspection services of the other Party shall forward a copy of the last inspection report of the manufacturing or importing site or, in case analytical operations are contracted out, also of the contract site. This shall in particular apply when the inspection included an assessment of compliance of manufacture and control tests for a medicinal product in accordance with the particulars and documents submitted for a marketing authorisation or when the inspection was performed in response to a quality defect. Each Party shall deal with these inspection reports with the degree of confidentiality requested by the providing Party. Parties will ensure that inspection reports are forwarded in no more than 30 calendar days, this period being extended to 60 days should a new inspection or re-control be carried out.