Good Distribution Practices News

On 27 June 2013, the EU Commission updated the so-called "Compilation of Community Procedures on Inspections and Exchange of Information". This document serves the exchange of information and the harmonisation of inspection standards between all the EU Member States. Read more details here.

The long awaited EU GDP Guidelines was published in the Official Journal of the European Union by EU Commission on 7 March 2013. This document will replace the current GDP Guideline published in 1994 (94/C 63/03).  Click here to read more.

The EU Commission has published a draft guideline on Good Distribution Practices for APIs. The GDP regulations for distributors and distributing companies partly contain very strict requirements. Read more here.

In order to change the "old" Good Distribution Practices Guideline from 1994 the European Commission published a proposal for a new version on 15 July 2011. The EU Commission received a large number of comments from stakeholders. But what are the next steps? Please find more in our GMP News.

In the USP Pharmacopeial Forum, you can find a new general chapter on "Good Distribution Practices - Supply Chain Integrity". The main issue focuses on measures to be taken against counterfeit medicines ("Best Practices to combat Counterfeit Drugs and Medical Devices") and actions to avoid theft during transportation ("Good Trucking Security Practices"). Read more in the News.

The guidelines on Good Distribution Practice have been thoroughly revised and published for comment by the EU Commission on 31 December last year. Each single comment can now be consulted on the Commission website. Read more here.