Galsulfase for enzyme replacement therapy

The tender documents include mandatory exclusion grounds based on final convictions, at least for participation in a criminal organisation, corruption and fraud. If such a ground applies, the bidder may be allowed to show self-cleaning measures, but this depends on the tender documents and the applicable rules. The machine-readable notice did not include the full list of exclusion grounds, so the official tender documents must be checked.

The bidder must hold a wholesale licence for human medicines. The contracting authority will check this in the medicines licence register. When submitting the bid, the bidder must confirm that the bid complies with the tender documents, that any equivalence has been explained and supporting evidence has been attached where needed, and that the bid price is submitted in the required structure. If this is a joint tender, a power of attorney for the joint bidders must be attached. The bid submission form must be completed. The machine-readable notice did not include any more precise qualification or compliance requirements; these must be checked in the tender documents.