Review of the guidelines on good distribution practices of medicines for human use: ref 2013 / C 343/01
As of November 5, 2013, the revised guidelines on good distribution practices have been published in the Official Journal of the European Union.
These guidelines took effect on September 8, 2013. It must be followed by both holders of a drug distribution authorization (Article 12b of the Act of 25 March 1964 on medicines) by holders a drug manufacturing authorization (Article 12 bis of the law of 25 March 1964 on medicines) engaged in distribution activities (including storage). These revised guidelines are intended to more precise and more explicit than previous. On the other hand, new requirements are also addressed.