Swissmedic: Guidance on GMP-Compliance by Foreign Manufacturers and RP Declaration

The Swissmedic Guideline on GMP-Compliance by Foreign Manufacturers was published on 1.5.2023 as version 3.0. It is addressed to the holders of marketing authorisations for medicinal products from abroad or from Switzerland if these medicinal products contain active substances from foreign manufacturers.

The guideline clarifies which documents must be submitted with the marketing authorisation application or with the notification of a change to demonstrate that the GMP conformity check has been carried out by the responsible person (RP) in accordance with Art. 11 para. 1 part i Medicinal Products Licensing Ordinance (MPLO). For this purpose an existing GMP certificate which must not be older than three years and certifies GMP conformity equivalent to Switzerland may be sufficient or if applicable a corresponding audit report.

The following amendments have been introduced:

• Chapter 5, which deals with verifying the conformity of foreign medicinal products and active substances, now contains a hierarchy of the documents to be submitted.
• Chapter 6 on audit reports now specifies how, when and what information must be submitted to Swissmedic.
• In Chapter 9 on inspections by Swissmedic, it has been added that an application can be put on hold until an inspection has taken place.

The guidelines and the new form for the declaration of the RP for foreign manufacturers can be found here.

Source:

Swissmedic: News and Updates