Q & A about package leaflets and labelling
These questions and answers are a supplement to Guideline no. 9203 of 4 March 2022 to the Danish executive order on labelling etc. of medicinal products and Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, newest version.
Unless otherwise stated, the answers apply to both the human and veterinary areas.
As regards the labelling of Nordic packages, please see Guideline on Nordic Packages and the FAQ on the Swedish Medical Products Agency's website.
Executive order no. 869 of 21 July 2011, as amended, about the executive order on labelling etc. of medicinal products is referred to as the executive order on labelling etc. of medicinal products.
Can the route of administration ”For ocular use” be stated as ”For use in the eye” on the labelling?
Answer: Yes, this is accepted. Danish Drug Standards contain a list of user-friendly terms that can be used to indicate the route of administration on the labelling.
Can a medicinal product be labelled ”sugar-free”?
Answer: Yes. However, in order to be termed ”Sugar-free”, the medicinal product must be free from monosaccharides and disaccharides (= glucose, fructose and galactose as well as combinations thereof).
How fast should variations be implemented into the package leaflet?
Answer: Generally, the deadline for implementing variations into the package leaflet is one year if it appears from the current package leaflet that the most recent package leaflet is available at indlægsseddel.dk and the updated package leaflet is uploaded no later than 3 months after approval of the variation.
As concerns package leaflets of veterinary medicinal products, we recommend to insert this information between the package leaflet heading and the section with the name and address details of the marketing authorisation holder.
If these two conditions are not satisfied, changes to the package leaflet must be implemented within 6 months after approval of the variation.
In this context, implementation means the time when packages with the updated package leaflet are supplied to the wholesaler.
(Ref.: Guidelines no. 9846 of 6. juli 2020 on variations to marketing authorisations for medicinal products).
Should updated package leaflets and labelling be submitted to the Danish Medicines Agency for approval?
Answer:
EU procedures (MRP/DCP): Changes to the package leaflet and labelling authorised under an EU procedure, including art. 61.3 notifications, are reflected in the updated End of Procedure documents. Any comments from the Danish Medicines Agency will be specified in the Danish authorisation letter.
The Danish Medicines Agency will not make any further review of the updated documents, and consequently the updated documents should not be submitted to the Danish Medicines Agency for further comments/information.
National procedures: Any comments from the Danish Medicines Agency will be specified in the authorisation letter.
The Danish Medicines Agency will not make any further review of the updated documents, and consequently the updated documents should not be submitted to the Danish Medicines Agency for further comments/information.
The MAH is responsible for ensuring that the documents meet the requirements in Executive order 869 of 21/07/2011, as amended, on labelling etc. of medicinal products, and Guideline no. 9203 of 4 march 2022, on labelling etc. of medicinal products.
The updated package leaflet should be uploaded to the package leaflet database
When and how should the product information as a result of the updated Exipients Guideline be implemented?
The changes have suspensive effect and should for authorised medicines be implemented in connection with the next type IB or type II variation in category C involving the product information. If it is not possible to perform an update in connection with another regulatory submission involving the product information, a type IB variation should be submitted within 3 years after the publication of the revised annex, cf. the recommendations on the website of the EMA.
Does the Danish Medicines Agency accept warnings on Danish labelling announced by other national authorities?
Denmark does generally not accept other countries’ nationally determined warnings on Danish labelling without a prior specific assessment.