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. We already reported about the comprehensive changes in our GMP News dated 20. July 2011. A large number of individuals, associations, companies and authorities responded to the proposed GDP Guideline. The comments have been available on the European Commission Webpage since 1 February 2012. (see our GMP News dated 22. February 2012). But what will happen next? What are the consequences?
It is very likely that the next steps will be as follows:
Some authorities and regulatory consultants expect the draft to be implemented in its current form (i.e. there will not be many changes).
Many stakeholders see major challenges e.g. in the new chapter 9.1.
The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described on the packaging information.
This requirement might be changed in the final version to a more risk based approach. However, there are also statements from stakeholders in industry and regulatory authorities who believe that the requirement will remain in the final version.
The implementation and interpretation of the new requirements in each Member State might lead to a complex regulatory environment. The quality standards of the logistic providers differ significantly across Europe. Pharmaceutical manufacturers will need to monitor the distribution process more closely than they did in the past. As a result, there might be a trend to reduce the number of contracted parties and to use more so called 3rd Party Logistic Providers (3SL).
Because of the short deadline for coming into operation pharmaceutical companies as well as Logistic Service Providers should already start now to evaluate a way to implement key provisions of the new guideline.
To inform about the new GDP Guideline the ECA organises a training course in Berlin.