For an application for authorization (new application) or a minor change of type IA/IAIN to be reported retrospectively, a minor change to type IB that must be reported in advance, or a major change to type II of an authorized human medicinal product, or for a new registration or a change with or without evaluation of an authorized veterinary medicinal product, certain documents must be submitted as evidence of GMP compliance testing of foreign manufacturers by the responsible person (RP).
Since, according to the MPLO, it must be demonstrated that foreign manufacturers work in accordance with the GMP requirements applicable in Switzerland, the supporting documents should generally be issued by authorities whose GMP control system is considered equivalent. If no such certificate is available, an audit report may also be submitted as proof of GMP compliance under certain conditions.
Swissmedic has provided clarification on the topics that must be taken into account during the audit, depending on the manufacturing activities applied for. General conditions for the submission of audit reports have also been added:
- The approved audit report is expected to be available when the application is submitted in order to demonstrate the manufacturer's GMP compliance. The manufacturer's authorization is based on the audit report, which is why prior approval of the manufacturer is not possible without the submission of a final audit report.
- Audit reports from a re-audit with a reduced, risk-based audit scope are also accepted as audit reports. In these cases, however, it must be ensured that all information required for the assessment of GMP compliance is still submitted. This can be done, for example, by submitting an assessment prepared by the RP or a summary based on the original complete audit covering the missing points.
- Redacted documents (report/CAPA plan) will only be accepted if the assessment of the report is not impaired.
- The audit report will only be reviewed if it is current (no older than three years) and covers the relevant active substance/finished product.
The guidance now also contains clarifications on the submission of inspection reports from authorities whose GMP control system is considered equivalent by Switzerland. Inspection reports from recognized authorities are accepted if they are not older than three years, the inspection was carried out on site, and it relates to the medicinal product (active substance) or ready-to-use medicinal product in question.
For the authorization of veterinary medicinal products under the notification procedure pursuant to Art. 39 VAZV or, if relevant, for the modification of such preparations, only one copy of the GMP certificate or manufacturing authorization per foreign manufacturer of the ready-to-use medicinal product needs to be submitted. If no GMP certificate or other document from a recognized authority is available as proof of GMP compliance, a risk assessment by the RP may be submitted as an alternative. Swissmedic has issued recommendations on the information required in the risk analysis submitted so that the risk assessment demonstrates that the manufacturer's GMP compliance is guaranteed.
The amended guidance document will be valid from May 1, 2025.