Swissmedic released a new version of its application form for authorisation and variation for human medicine.
The form has been modified to implement changes due to the launch of eSubmission platform and to update terminology for complementary medicines. However the most significant change is the addition of a new section for information on the medical device component of a medicinal product (combination product).
This new section introduce new requirements for the medical device component:
- If the device component can be separated for the drug (non-integral combination), the device must be CE marked.
- If the combination is integral (e.g. prefilled syringes), the device is not CE marked but the applicant must demonstrate the conformity of the device to the relevant Essential Requirements of the Medical Devices Directive (93/42/EEC)
- The applicant must demonstrate the suitability of the device for the specific medicinal product (dosing accuracy, compatibility…)
- In cases of innovative and complex combination products, Swissmedic requires that the suitability is demonstrated in an additional expert report. This report can be issued by a conformity assessment body and/or an EU competent authority.
The new form entered into force as of 1 July 2017. Previous versions will be accepted during the transition period until 30 October 2017.
Click here to access the new form and guidance on the Swissmedic website.