Good Distribution Practices News

DHMA has recently updated its "wholesale distribution of medicines within the EU/EEA questions and answers" document. It gives some valuable information for those who distribute medicines in, from and to Denmark. Read more.

The European Commission has launched the long expected draft of the revised Annex 15 (Qualification and Validation) for public consultation (see our news from 12 February). with a new chapter on verification of transportation. Read more.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a document to clarify the interpretation of the new EU Good Distribution Practice (GDP) Guideline. Click here to read more

The Good Distribution Practice Group (GDP Group) has summarized all language versions of the new GDP Guide. Please click here for more information 

The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) announce the availability of two draft chapters on the interpretation of the new EU GDP Guideline. Please find more here.

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.