Recall of medicinal products

In case recall of a medicinal product is deemed necessary, it is the responsibility of the marketing authorisation holder to conduct the recall. The Danish Medicines Agency may take part in discussions on how to plan and conduct the recall most efficiently and may give advice on practical questions, for example, the need for information.

Contact the Danish Medicines Agency before initiating a recall

The Danish Medicines Agency must be contacted before initiating a recall. Companies are required to contact the Danish Medicines Agency to ensure an efficient recall, and that the possible impact of the recall in the supply chain or among patients is addressed.

See ”Reporting of product defects” for further information.

The company and the Danish Medicines Agency will jointly determine which parts of the supply chain will be included in the recall. The affected levels in the supply chain could, for instance, be

• wholesale distributors
• pharmacies, hospital pharmacies, retail distributors
• hospital departments
• patients, end-users

Product recall notification

Before the recall is conducted, the marketing authorisation holder or their representative must prepare a draft “medicine recall notification” in Danish using the template below. The draft notification is submitted for review by the Danish Medicines Agency before being dispatched.

The marketing authorisation holder or their representative dispatches the medicine recall notification upon agreement with the Danish Medicines Agency to the agreed recipients via email.

Template (Medicine recall notification):
Meddelelse om tilbagekaldelse af lægemiddel (word)

Guidance to completing the recall notification template:

Vejledning til udfyldelse af Lægemiddelstyrelsens skabelon for tilbagekaldelsesbrev (pdf)

Contacts

The marketing authorisation holder is responsible for obtaining the contact information of the agreed recipients.

If hospital pharmacies need to be informed urgently in medicine recall matters, please see the website of Amgros for contact details. Please note that private hospital pharmacies are not included in the list provided by Amgros.

The private hospital pharmacy ‘Aleris Sygehusapotek’ may be contacted at Send an email.

Communication to patients

If a product defect is deemed to have unacceptable consequences for patient safety, and the concerned medicine is recalled at the patient level, the information will generally also need to be communicated through the media. If so, the marketing authorisation holder should prepare a press release. The dispatch of information should always be agreed with the Danish Medicines Agency in advance.