Manufacturer Data of Primary Packaging Materials in the Dossier

Should information on the manufacturers of primary packaging materials (e.g. glass syringes) be included into the dossier, and if so, where is the best place to do so?

If possible, this information should be provided in Module 3.2.P.7, rather than in 3.2.P.3.1, and thus submitted to Swissmedic for information.

Your contact

Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director

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