Public consultation opens on the revised guideline on good distribution practice of medicinal products for human use
The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) has launched a public consultation on the revised ‘Guideline on Good Distribution Practice of Medicinal Products for Human Use’. The European Medicines Agency through its GMP/GDP Inspectors Working Group worked on the revision of the guideline which was first published in 1994.
The guideline was revised to take into account developments in the storage and distribution of medicinal products in the European Union and to meet new requirements for wholesale distributors and brokers established in the new Directive 2011/62/EU on falsified medicines.
The draft guideline is of particular interest to wholesale distributors and brokers of medicinal products for human use as well as for manufacturers who distribute their own products.