Preparation and distribution of Danish educational material

15 November 2016, Updated 27 January 2023

The obligation imposed on the marketing authorisation holders to prepare and disseminate educational materials is described in the applicable legislation and guidelines in this area.

The content of the educational material is described in the risk management plan in the form of key elements. However, in some cases, the content of the educational material may be based on an approved English text.

For nationally approved medicinal products (including MRP and DCP approved medicinal products) please also refer to the summary of the risk management plan.

For centrally approved medicinal products, please also refer to the European Medicines Agency (EMA) website for published EPARs (European Public Assessment Report) for further information about individual medicinal products and their respective risk management plans.

For educational materials for distribution in Denmark the marketing authorisation holder must provide the below list of documents to the Danish Medicines Agency:

The submitted educational material must be accepted by the Danish Medicines Agency before the medicinal product is marketed in Denmark.

Educational materials should be forwarded to this e-mail and please write ”EDUMAT” as the first word in the e-mail subject field.

The marketing authorisation holder must await the evaluation and the acceptance of the Danish Medicines Agency before they can distribute their educational material.

The Danish Medicines Agency aim to complete the assessment of the Danish educational material no later than 60 days after receipt of all the above-mentioned documents.  In case of deficiencies the deadline will be postponed and the completion deadline will be reset to the date on which all required documents are received.

Sometimes, an accelerated evaluation is needed for medicinal products approved via the centralised procedure. This applies for new medicinal products that are planned to be marketed in Denmark for the first time. In such cases, the Danish Medicines Agency has up to 30 days for the national implementation of the EU Commission decision in accordance with internal management practice or in case of safety concerns for updated educational material.

After the educational material has been adjusted to meet the evaluation from the Danish Medicines Agency, the marketing authorisation holder must send out the final accepted educational material to the relevant recipients listed on the agreed distribution list in accordance with the agreed distributions channels and timeframe.

The marketing authorisation holder should send the final agreed educational material to the Danish Medicines Agency via e-mail for publication on the Danish Medicines Agency website. Before the educational material can be published here, the marketing authorisation holder must forward the latest agreed written educational material in one combined pdf-file.

The order of the content is secondary (e.g. “doctor – patient – pharmacy”). The most important thing is that the educational material is combined in one file.

If the educational material contains a video or other digital file formats this is not published.

The educational material for publication should not contain the product information and/or package leaflet. Reference must instead be made to www.produktresume.dk and/or www.indlaegsseddel.dk for the nationally approved medicinal products (including MRP and DCP). For centrally approved medicinal products a reference must be made to EMA’s website, EU Commisions website and/or www.indlaegsseddel.dk

It is the marketing authorisation holder who has the overall responsibility for ensuring that the Danish Medicines Agency has the latest accepted written educational material available for publication.

In cases the same requirement for educational material is set under different procedures, the Danish Medicines Agency encourages the marketing authorisation holders involved to collaborate in the preparation of the educational material. The Danish Medicines Agency also recommend that the marketing authorisation holders collaborate on the dissemination of the educational material to make sure that one common set of educational material is distributed to the recipients on the agreed distribution list.

The Danish Medicines Agency reserves the right to return the proposed educational material to the marketing authorisation holder if the quality of the educational material is unsatisfactory due to too many errors, omissions and/or misunderstandings.

The marketing authorisation holder has the overall responsibility for the educational material and for ensuring that it complies with the conditions of the marketing authorisation.

Questions regarding this procedure can be directed to this e-mail.