Additional provisions for packaging, labelling and delivery of magistral and officinal preparations for cough and colds.

On March 23, 2018, the royal decree (RD) dated February 23, 2018 was published in the Belgian Legal Gazette that amends two previous decrees: the RD dated June 17, 2013 regarding the packaging, labelling and delivery of magistral and officinal preparations for cough and colds and the decree from the regent dated February 6, 1946 containing the regulation on the storage and sale of toxic substances.

Not all measures were directly applicable after publication of the RD in 2013. The royal decree (RD) dated February 23, 2018 proposed the inception of articles 2 and 5 of the royal decree dated June 17, 2013 regarding the packaging, labelling and delivery of magistral and officinal preparations for cough and colds and to change the decree from the regent dated February 6, 1946 containing the regulation on the storage and sale of toxic substances:

  • the primary packaging of the affected drugs in liquid form must be secured with a cap that prevents accidental ingestion, effective the first day of the fourth month after publication in the Belgian Legal Gazette, thus from July 1, 2018.
  • officinal preparations for cough and colds must only contain one active ingredient from January 1, 2020.

The measures from the RD dated June 17, 2013 remain in effect (see the report dated April 25, 2013).

This RD sets up the measures applicable to magistral and officinal preparations for human use against cough and colds and which contain the following ingredients:

  • dextromethorphane, pentoxyverine, levodropropizine, noscapine, cloperastine, pholcodine, codeine, dihydrocodeine, ethylmorphine and thebacon, or their isomers, salts, esters and ester salts;
  • guaiphenesin or the isomers, salts, esters and ester salts of this substance;
  • phenylephrine, ephedrine, naphazoline, tramazoline, oxymetazoline and xylometazoline or their isomers, salts, esters and ester salts in nasal pharmaceutical forms.

More information

The royal decree dated February 23, 2018

Last updated on
07/06/2018