Manufacturers and wholesale distributors must be contactable outside opening hours

22 September 2016

GDP and GMP companies' availability outside normal opening hours

The Danish Medicines Agency will make calls to companies’ main phone numbers, or emergency lines, to check that wholesale distributors and pharmaceutical manufacturers are contactable outside normal opening hours and during holidays.

According to section 31 of the GDP executive order and section 30 of the GMP executive order, wholesale distributors and pharmaceutical manufacturers are obliged to introduce an effective system for the processing of complaints, which makes it possible to initiate recall operations of medicinal products in the distribution network promptly and at any time.

Must be contactable around the clock

We expect 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.

Contact details must be readily available

We also expect 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, we expect that a call to your main phone number will inform about the possibility to call the relevant phone number. Any unanswered calls should be returned as soon as possible.

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