Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.
The need for better control of the pharmaceutical supply chain was raised throughout discussions about adoption of the European falsified medicines directive. Now, with the directive adopted, the European Commission (EU) has published draft good distribution practice (GDP) guidance.
“Today’s distribution network for medicinal products is increasingly complex and involves many players. The quality and the integrity of medicinal products can be affected by a lack of adequate control over the numerous activities, which occur during distribution”, reads the draft guidance .
Supply chain complexity creates opportunities for biopharmaceutical counterfeiters and adulterers and the draft guidance recognises “it is also necessary to address the threat that falsified medicinal products pose to the distribution channel”.
Current European GDP guidance was published in the 1990s and, considering the changes to the supply chain since then, is considered to be inadequate by the EC. Advancements of practices for appropriate storage and distribution are two elements the EC has considered in the draft.
GDP Europe.pdf (176.4 KB)