Good Distribution Practices News

There is not much time left until the safety features have to be implemented. These features are required to comply with the Falsified Medicines Directive, which will enter into force on 9 February, 2019. Meanwhile, a number of national data storage and retrieval systems have joined the EU Hub, as the European Medicines Verification Organisation (EMVO) reported.

Data Integrity is still a hot topic in GMP inspections. And in the GDP area data integrity is also increasingly becoming a subject, as some examples from the MHRA show.

A new draft EMA Guideline requires that GDP-Guidelines for medicinal products should be taken into consideration for IMP shipments.

In October 2017, the ICMRA adopted recommendations on the implementation of Track and Trace (T&T) Systems to emphasise the importance of the complexity of these systems. This is relevant for regulatory authorities as well as for the pharmaceutical industry. Find out more about the ICMRA T&T recommendations.

Safety features, which will be mandatory in the future to put the Falsified Medicines Directive into practice, must be implemented by 9 February, 2019. The European Commission has published version 9 of their questions and answers on safety features in February 2018. Find more information on the EU's revised Q&A document on safety features.

A new FDA guideline is supposed to help the industry in identifying suspicious or illegitimate products. All trade partners are asked to initiate specific actions if such products turn up. Find out more about the FDA instructions in suspicious and illegitimate products.

During the last year, the notifications on mechanical defects and reported suspicions of counterfeits increased. Distributors should also be interested in these figures.