Today’s distribution networks are increasingly complex and involve many players; therefore, it is essential to refer to a common rulebook: the Good Distribution Practice (GDP).
To whom does the Good Distribution Practice apply?
Anyone importing, holding, procuring, supplying or exporting medicinal products or active substances has to adhere to these guidelines.
Compliance with the GDP ensures that:
- pharmaceuticals are always transported and stored under the right conditions
- contamination, theft or tampering is prevented
- recalls and complaints can be effectively managed
- only authorised pharmaceuticals enter the distribution network
Legal framework and inspections.
Directives 2001/83/EC and 2001/82/EC regulate the distribution of medicines in the EU; additional, two sets of guidelines define the GDP for medicinal products and the GDP for the distribution of active substances.
Anyone engaged in the wholesale distribution of medicinal products needs to hold a WDA Wholesale Distribution Authorisation issued by national authorities.
After inspecting a wholesale distributor, EU competent authorities issue a GDP certificate or a non-compliance statement, which is entered in the public accessible EudraGMDP database.
It is important to note that manufacturers and wholesalers are legally liable for their subcontractors and their compliance with the GDP.
When choosing the right partner for the distribution, it is not only important to make sure that full compliance is guaranteed, but exceeded.
Carrymed is a holder of a Wholesale Distribution Authorisation and is a regulated agent specialised on the international transport of temperature-sensitive pharmaceuticals.
Get in contact to see how we can support you in the distribution of your products.
