Submission of final Assessment Reports

If available, do final Assessment Reports always have to be enclosed with applications?

In the form «Status of authorisation applications abroad HMV4», it now has to be specified whether or not a final Assessment Report from the authorities/countries mentioned in the form is available. Where available, Swissmedic stipulates that applicants should always submit final Assessment Reports from foreign authorities. A strict legal requirement exists, however, only for applications applying Art. 13 HMG [HMV = Swiss Law on Therapeutic Products]. If an applicant fails to voluntarily submit a final Assessment Report from a foreign authority, Swissmedic stipulates shall the reasons for refusing to submit information that would facilitate the review process for Swissmedic and, in many cases undoubtedly speed up the process, shall be stated in the cover letter.

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Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director

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