Good Distribution Practice for wholesale in medicines
On 23 November 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 5 November 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.
(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