S.L. 458.63 Art. 7Responsibilities of permission holder. 3

At the time of application and during the period of validity of the permission, the permission holder shall:

(a) bear full responsibility of the medicinal product;

(b) declare that it does not have access to any equivalent medicinal product which is registered or may be registered under the Act or any other legislation within the applicable time frame;

(c) declare that the permission is being requested due to a justified public health need and that the patient would remain without the medicinal product if permission is not granted:

Provided that a public health need includes but is not limited to accessibility, excessive pricing, seriousness of the circumstances of the case and product risk.