Good Distribution Practice

Good Distribution Practice for wholesale in medicines

On 7 March 2013, the European Union published revised guidelines regarding the Good Distribution Practices (GDP) for medicines for human use in its official journal. These guidelines entered into force on 8 September 2013. They are applicable to wholesale distribution authorization holders of medicinal products1  as well as to manufacturing authorization holders2 involved in distribution activities (storage included).

Certain dispositions in the royal decree of 14 December concerning medicines for human and veterinary use are also applicable to the wholesale of medicines.

The FAMHP has compiled a document containing questions and answers to help professionals interpret and apply GDP legislation correctly (available in Dutch & French).

(1) Article 12ter of the law of 25th of march 1964 on medicinal products
(2) Article 12bis of the law of 25th of march 1964 on medicinal products

Link to the form RAS (Dutch or French)

Last updated on 30/10/2019