Thresholds for active substance in certain OTC medicines sold in general sales outlets

26 February 2014

In Denmark, it is permitted to sell certain OTC medicines in non-pharmacy outlets (these products fall within dispensing group HF).

For OTC medicines with active substance appearing from the below list, the Danish Medicines Agency has decided that only 1 package can be dispensed per customer per day (dispensing group HX or HX18), when the medicines are dispensed by distributors with an authorisation for retail distribution of OTC medicines, i.e. outside pharmacies.

In addition, the Danish Medicines Agency has fixed an upper threshold for the package size based on the content of active substance that is dangerous for humans when consumed in large doses.

Consequently, these medicines only fall under dispensing group HX or HX18 if the total amount of the active substance falls below or equals the threshold specified, see the list below. Packages containing higher amounts of the active substance fall under dispensing group HA or B, which means that they can be sold in pharmacies only.

The range of OTC medicines, which in limited content of active substance falll under dispensing group HX or HX18, was last updated in September 2013.

 

ATC code

Active substance

Threshold

M01AE01

Ibuprofen

4 g

B01AC06

or

N02BA01

Acetylsalicylic acid 

5 g

N02BA51

Acetylsalicylic acid COMB.

5 g

N02BE01

Paracetamol

5 g

R06AD02

Promethazine

250 mg

D06BB03

Aciclovir

250 mg

N02BB51

Phenazone COMB.

5 g


Example: In the case of paracetamol 500mg tablets, packs containing more than 10 tablets fall under dispensing group HA18 whereas packs containing 10 tablets or less fall under dispensing group HX18.

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