Regarding combination products, the following subheadings have been added to section 2.5.15 of the guidance document Formal requirements HMV4:
- Application for authorisation of a non-integral combination product
- Application for authorisation of an integral combination product
Also, this guidance document did not previously contain requirements in section 3.22.6 “Parallel import”. The following requirement has now been added here:
Should there be a change to the wholesaler or supplier of the medicinal product imported according to Art. 14 (2) TPA, an updated version of the form Import of a medicinal product according to Art. 14 (2) TPA (parallel import) HMV4 must be submitted.
This change has therefore also been applied in the form Import of a medicinal product according to Art. 14 (2) TPA (parallel import) HMV4. The name and address of the wholesaler and/or supplier must now be entered here. The name and address of the Qualified Person is no longer required.
The revised documents are valid as of 1 October 2021.