Information on proposed amendment of the Pharmaceutical Law has been published in the Public Information Bulletin of the Council of Ministers

The aim of designed changes is to standardize and precise regulations regarding the system of supervision over manufacturing and distribution of medicinal products, as well as to ensure their full compliance with provisions of the Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use.

This amendment is likely to be introduced in the nearest future in view of an audit concerning the aforementioned system, planned on the fourth quarter of the year 2016, by representatives of the European Union with participation of the Food and Drug Administration (FDA).
 
For more information please visit the website: https://bip.kprm.gov.pl/kpr/bip-rady-ministrow/prace-legislacyjne-rm-i/prace-legislacyjne-rady/wykaz-prac-legislacyjny/r2420,Projekt-ustawy-o-zmianie-ustawy-Prawo-farmaceutyczne.html