Art. 13 HMG (Heilmittelgesetz [Therapeutic Products ACT]) – FDA as the reference authority

What points must be taken into consideration when creating the Swiss market product information on the basis of the US PI for applications in accordance with Art. 13 HMG?

For applications in accordance with Art. 13 HMG with the FDA as the reference authority, the templates for the Swiss medicinal product texts must be used when creating the Swiss medicinal product information. The sections are to be supplemented with the corresponding sections from the US PI. Swissmedic will check that the data has been included correctly. If there are areas that are unclear, this may lead, in certain circumstances, to a partial assessment of the documentation. Furthermore, Swissmedic must check the points specific for Switzerland (e.g., storage instructions) or congruence with the medicinal product information for medicinal products in the same application area. If an EU SmPC is available, this cannot be used as the basis for the Swiss market product information, as the FDA has been selected as the reference authority.

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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