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Thresholds for the total amount of active substance in certain medicinal products sold in general sales outlets

In Denmark, it is permitted to sell certain over-the-counter medicinal products in non-pharmacy outlets (these products fall within dispensing group HF). For some of these medicinal products, the Danish Medicines Agency has previously fixed thresholds for when the content of a certain active substance is dangerous for humans when consumed in large doses (dispensing group HX – available outside pharmacies in limited amounts only).

Consequently, these over-the-counter medicinal products fall under dispensing group HX when the total amount of the active substance falls below the threshold specified, see the list below. Packs containing higher amounts of the active substance fall under dispensing group HA, which means that they may be sold only in pharmacies.

The range of over-the-counter medicinal products in dispensing group HA which, when sold in restricted pack sizes, fall under dispensing group HX was last updated in April 2007 and is based on the following substances. 

ATC code

Active substance

Threshold

M01AE01

Ibuprofen

6g

N02BA01

Acetylsalicylic acid

5g

N02BA51

Acetylsalicylic acid COMB.

5g

N02BE01

Paracetamol

5g

R06AD02

Promethazine

250mg

D06BB03

Aciclovir

250mg

N02BB51

Phenazone COMB.

5g


Example: In the case of ibuprofen 200mg tablets, packs containing more than 30 tablets fall under dispensing group HA whereas packs containing 30 tablets or less fall under dispensing group HX.

For further information, please contact Maria Bruun +45 4488 9724.

The Danish Medicines Agency, 27 June 2007

Created 29 June 2007