Following the TPA2/HMV4 information events held on 25 October and 9 November 2018, Swissmedic published an extensive catalogue of questions and answers on HMV4-related topics under “Revision of the TPA”.
These questions and answers, which were gathered at the information events, have since been expanded upon in the light of initial experience with the new processes. On the Swissmedic website, these will no longer be located under “Revision of the TPA” but can now instead be found directly in the relevant guidance documents in the form of conventional Q&A documents.
The questions and answers on the following topics have already been consolidated in Q&A documents and published in the relevant guidance documents:
- Questions and answers on variations and extensions HMV4
- Questions and answers on the Paediatric Investigation Plan HMV4
- Questions and answers on the new procedures according to Art. 14 para. 1 letter abis-quater TPA HMV4
Further HMV4-related topics will be published in Q&A documents on an ongoing basis until the end of 2019.