Commentaries: Art. 44

Any person who imports the following medicinal products that are authorised or not subject to authorisation or blood and blood products into Switzerland requires a licence for each shipment:
1. immunological medicinal products;
2. blood and blood products.
A licence is not required for the import of individual batches of:
1. allergens;
2. blood that is authorised or not subject to authorisation and blood products of this kind if these medicinal products:
1. are imported in medical emergencies or for autologous transfusion, 2. are not intended for use in humans, or 3. have an official batch release from one of the control authorities belonging to the Official Control Authority Batch Release Network (OCABR Network); c. immunological medicinal products that are authorised or not subject to authorisation provided an official batch release from one of the control authorities belonging to the OCABR Network is available for the batch to be imported.
In the interest of protecting health, Swissmedic may impose temporary or permanent mandatory licensing on the import of individual batches of immunological medicinal products or of blood and blood products that are authorised or not subject to authorisation even if an official batch release as described in paragraph 2 letter b number 3 is available.