Packages for orphan drugs

Are there differences between EU and Swiss packages for orphan drugs?

As some orphan drugs are only produced in small quantities, it is possible in the EU to produce packages for the whole EU with only English text. It is important to know that this special regulation does not apply to orphan drugs in Switzerland. Even if a medicinal product is authorised for a very rare disease, the packaging texts must always be given in at least 2 official languages (exception: in the case of exclusive use in hospitals or by defined medical specialists, packaging texts can only be written in one official language or in English).

Your contact

Any questions?
I would be delighted to answer them.

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