Labelling - questions and answers
What does it mean that ”long-term effect” has been added in Section 11?
Certain medicinal products for which a package leaflet was not previously required now require a package leaflet. E.g. parenteral slow-release medicinal products and vaccines that are already described in the guideline on labelling of and package leaflet for medicinal products.
When should special precautions for the disposal of the medicinal product be stated on the labelling?
If there are special precautions in the SPC, such precautions shall also be stated on the labelling.
Is it no longer a requirement that the generic name of the medicinal product should be printed at half the size of the invented name?
Yes, but the requirement has been moved from Section 6 (3) of the previous Danish Medicines Act to Section 22 (4) of the new Executive Order on labelling etc of medicinal products.
Is the order stated in the guideline on drawing up package leaflets of pharmaceutical specialities for human use from March 2004 still applicable?
The order of the information of the package leaflet stated in Section 39 (1) is the correct order, however, the texts of the guideline may still be used unless the information requirement has changed according to the Executive Order.
Can only the actual package size be stated in the package leaflet?
No, authorised or marketed package sizes may be stated in the package leaflet. Information may be added that not all package sizes are marketed.
When should the results of the cooperation with patient target groups be available?
For applications after 30 October 2005 the application shall include results from cooperation with patient target groups or the the lack of results/cooperation should be justified.
In which language should the user test be carried out?
No specific language is required, however, the results of the test shall be included in the application in Danish or English. Translations of the package leaflet shall be of a high quality.
Should a (new) user test be carried out in connection with changes to the package leaflet?
As a starting point, it is not necessary to carry out a new user test. It should however be considered in connection with variations that result in significant changes to the package leaflet.
Are there any requirements of user test in connection with changes to the package leaflet due to the harmonisation project?
No, there is no requirement of a (new) user test in connection with changes to the package leaflet.
Which transitional arrangement applies to Braille?
As a general rule Braille shall be stated on the package no later than 30 October 2010, irrespective of when the medicinal product is approved, cf. Section 41 (5) of the Executive Order (available in Danish only).
The exception is medicinal drugs included in the MRP or DCP for which Braille shall be included prior to 30 October 2010.
By when should other changes be implemented?
Medicinal products authorised on 30 October 2005 or later shall comply with the new legislation.
For medicinal products authorised on or prior to 29 October 2005 the changes shall be implemented prior to 1 January 2009, cf. Section 41 (6), unless the Danish Health and Medicines Authority decides otherwise, e.g. already-authorised MRP products.
When should the changes to the package leaflet be implemented if the medicinal product is part of the harmonisation project?
That will depend on whether the medicinal product has been through the project:
- If it has already been through the project: prior to 1 January 2009.
- If it has not been through the project: the date fixed for the specific medicinal product. The date may be before or after 1 January 2009 dependent on when the medicinal product enters the project.
- It is assumed that the medicinal product is authorised on or prior to 29 October 2005.
When will a new guideline on the Executive Order on labelling etc of medicinal products become available?
We still await the new EU Readability Guideline. The Guideline from May 2005 still applies regarding the provisions that have not been amended.
Is it still possible to have Nordic packages when Sweden has abolished the warning triangle?
The warning triangle may be affixed to the packages for the Danish market. The affixed triangle is additional labelling and has to meet the requirements for this.