Danish pharma companies and distributors must be available 24/7
Wholesale distributors and pharmaceutical manufacturers are obliged to introduce an effective system for the processing complaints, which makes it possible to initiate recall operations of medicinal products in the distribution network promptly and at any time.
The Danish Medicines Agency expects companies to be continuously contactable to be able to perform a recall, if required. It is not a requirement that the responsible person or the qualified person can be contacted directly.
But it must be ensured that the responsible person is informed about any enquiries that are relevant to his responsibilities, and the company should have relevant procedures for how to handle such calls.
The Danish Medicines Agency expects that contact details are made readily available to citizens as well as the Danish Medicines Agency.
If the company can be contacted on a special phone number outside opening hours, The Danish Medicines Agency expects that a call to the main phone number will inform about the possibility to call the relevant phone number. Any unanswered calls should be returned as soon as possible. ■