Requirements for "Blue box" and Package Leaflets - HUMAN medicinal products
Requirements for "Blue box" and Package Leaflets - HUMAN medicinal products
Danish requirements for applications for human medicinal products submitted through the mutual recognition procedure or the decentralised procedure. Danish requirements for “Blue Box” also apply to medicinal products approved via the purely national procedure.
Additional Requirements for the Labelling
Price
There is no requirement for the price to appear on the label.
Reimbursement
There is no requirement for the reimbursement conditions to appear on the labelling.
Legal status:
There is no specific requirement in respect of the legal status.
Identification and authenticity
The Nordic number is required on the outer labelling of all medicinal products, except radiopharmaceuticals, certain vitamins and mineral products, homeopathic, herbal and traditional herbal medicinal products. It may be written as “Vnr XX XX XX”.
A bar code is accepted but not required on the labelling.
Symbols or pictograms
Products which may reduce the ability to drive or operate machines must have a warning triangle.
The tip of the triangle points upwards. It is a red triangle on a white background. Its size is adapted to fit the label; its sides are as minimum 10 mm long and the width of the frame is usually 2 mm:
Other requirements
Other warnings to be included in the labelling are listed in section 29(3-5) and section 31(2-6) of the Danish executive order no 869 of 21 July 2011, as amended on labelling etc. of medicinal products (Danish title: Bekendtgørelse nr. 869 af 21. juli 2011 med senere ændringer om mærkning m.m. af lægemidler).
Additional Requirements for the Package Leaflet
| Section / Explanation | English translation | Danish text required in the Package Leaflet |
| Section 2, What you need to know before you <take> <use> X | Please notice that your doctor may have prescribed the medicinal product for a different therapeutic indication and/or at a different dosage than stated in the package leaflet. Always follow the doctor's prescription and the instructions on the dosage label. | Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg altid lægens anvisning og oplysningerne på doseringsetiketten. |
| Section 2, Driving and using machines -Only for products which carry the red warning triangle | The package contains a red warning triangle. This means that "X" can be sedating and can reduce the ability to drive and use machines. or The package contains a red warning triangle. This means that "X" can cause side effects that can reduce the ability to drive and use machines. or The package contains a red warning triangle. This means that "X" can be sedating and can reduce the ability to drive and use machines. This usually occurs at the beginning of treatment and when the dose is increased. |
Pakningen er forsynet med en rød advarselstrekant. Det betyder, at "X" virker sløvende, og at det kan påvirke arbejdssikkerheden og evnen til at færdes sikkert i trafikken. eller Pakningen er forsynet med en rød advarselstrekant. Det betyder, at "X" kan give bivirkninger, som kan påvirke arbejdssikkerheden og evnen til at færdes sikkert i trafikken. eller Pakningen er forsynet med en rød advarselstrekant. Det betyder, at "X" især i begyndelsen af behandlingen og ved stigning i dosis virker sløvende, og at det kan påvirke arbejdssikkerheden og evnen til at færdes sikkert i trafikken. |
| Section 3, If you <take> <use> more X than you should | Contact your doctor, hospital or pharmacy if you have taken more "X" than prescribed in this information or by your doctor (and you do not feel well). | Kontakt lægen, skadestuen eller apoteket, hvis De/du har taget mere af "X", end der står i denne information, eller mere end lægen har foreskrevet (og De/du føler Dem/dig utilpas). |
Other requirements
Section 2, Warnings and precaution for use, must include any warnings listed in Schedule 2 of the Danish executive order no 869 of 21 July 2011, as amended on labelling etc. of medicinal products (Danish title: Bekendtgørelse nr. 869 af 21. juli 2011 med senere ændringer om mærkning m.m. af lægemidler) pursuant to section 35 (1) (4d).
Requirements for labelling and package leaflets - VETERINARY medicinal products
Danish requirements for applications for veterinary medicinal products submitted through the national procedure, mutual recognition procedure or the decentralised procedure.
Additional Requirements for the Labelling
Identification and authenticity
The Nordic number is required on the outer labelling of all medicinal products, except radiopharmaceuticals, certain vitamins and mineral products, homoeopathic, herbal and traditional herbal medicinal products. It may be written as “Vnr XX XX XX”.
A bar code is accepted but not required on the labelling.
Legal status
There is no specific requirement in respect of the legal status.
Additional Requirements for the Package Leaflet
National reporting system
Lægemiddelstyrelsen
Axel Heides Gade 1
DK-2300 København S
Websted: www.meldenbivirkning.dk
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Section in the package leaflet |
English translation |
Danish text required in the package leaflet |
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Section 8 |
Please notice that your veterinarian may have prescribed the medicinal product for a different therapeutic indication and/or at a different dosage than stated in the package leaflet. Always follow the veterinarian's prescription and the instructions on the dosage label. |
Vær opmærksom på, at dyrlægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg altid dyrlægens anvisning og oplysningerne på doseringsetiketten. |