Newsletter

Reporting drugs to the Ministry of Health

 

Currently, there are works conducted in the scope of changes as regards data on trade in drugs, which as of the beginning of the next year will be reported by pharmaceutical companies to the Integrated System for Monitoring of Trade in Medicinal Products (ZSMOPL).

The current legislative works aim at limitation of the catalogue of drugs, the information on the trade of which is to be reported to ZSMOPL. The current versions of the draft provisions assumes that the Rx drugs and selected categories of OTC drugs will be subject to reporting.

In case of OTC drugs, it is mainly about the drugs, the equivalents of which are subject to medical prescription; the drugs containing psychoactive substances in their composition, the sale of which is limited (e.g. a drug with pseudoephedrine); as well as drugs containing highly potent substances in their composition.

It is worth mentioning that the criteria specifying the catalogue of drugs subject to the obligation of reporting to ZSMOPL are to be specified in a regulation of the Minister of Health. Therefore, the Minister will be given the possibility of changing the criteria independently, and thus of expanding or limiting the catalogue of drugs, the information on the trade of which will have to be included in the system. The drafted provisions assume that the decision of the Minister in the above scope will include the need to monitor the trade in products the specificity or limitation of availability of which may pose a particularly significant threat for public health.