New proposal pertaining to regulations on pseudoephedrine dispensation in Czech Republic

2010-01-26

The Health Ministry will forward to the Czech parliament a number of draft amendments to the Act on Medicines, in order to regulate over-the-counter sales of medicines containing pseudoephedrine, according to the Zdravotnicke Noviny online portal. The new draft stipulates that patients will be allowed to purchase two packets, or 60 pseudoephedrine tablets, per month, after presenting their ID cards at a pharmacy. To make sure that the limit is not exceeded, the amount of drugs dispensed will be entered in a central repository. The new amendments were developed in collaboration with the Czech Office for Data Protection (UOOU) to prevent legal problems with patient data collection.
The Health Ministry intends to ask parliament to adopt the new law on the first reading in order to implement it before the general election scheduled for the first half of 2010.
As we reported on a previous occasion in Central Europe Pharma News, in April 2009 the Czech government significantly limited access to medicines containing pseudoephedrine by introducing the registration of medicines sold together with patients’ IDs in a central repository. However, in November 2009 the UOOU ruled that the data collection and storage were in breach of the Czech law, which made further monitoring of dispensed pseudoephedrine products practically impossible.