The measure applies to antibiotics for human use, in solid oral form, in Class ATC J01.

Royal Decree amending the Royal Decree of 21 January 2009 laying down instructions for pharmacists, the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use and the Royal Decree of 15 November 2017 on the materiovigilance contact point

The measure concerns situations in which the packages available do not permit the exact quantity prescribed by the doctor to be dispensed, depending on the dosage and the duration of treatment.

In order to avoid a surplus of unsold products in pharmacies and to limit economic and logistical losses, the following active substances, with their ATC codes, are excluded:
cefalexin (J01DB01)
lincomycin (J01FF02)
ofloxacin (J01MA01)
norfloxacin (J01MA06)
roxithromycin (J01FA06)
The draft introduces an obligation for dispensers to dispense the medicinal products concerned only in the quantity corresponding to the prescription. Where the prescription is issued under the international non-proprietary name (INN) and none of the packages available permit the exact quantity prescribed by the doctor to be supplied, dispensers shall be obliged to split the packages.