First technical workshop on the Good Distribution Practices (GDP) of medical products in the WHO European region

On 27-29 January 2015  the Health Technology and Pharmaceuticals (HTP) unit in WHO/Europe organized a Good Distribution Practice (GDP) workshop in collaboration with the Danish health and medicines authority and the WHO Collaborating centre for drug policy and pharmacy practice development.

The European Union updated the GDP guidelines in 2013, recognizing the need to regulate the distribution channels in a proportionate, consistent and risk based manner. The goal of the workshop was to enhance understanding and compliance to GDP of medical products in The WHO European Region amongst others through sharing of practical experiences on the EU GDP Guideline implementation and the process for risk based inspection of the supply chain. The event in Denmark was attended by GDP inspectors and lawyers from Albania, Bulgaria, Estonia, Romania and Turkey. Sessions included quality management, personnel, premises and equipment, documentation, operations, complaints, returns, suspected falsified medical products, recalls, outsourced activities, self inspection, quality risk management and transportation.

Good distribution practice is a fundamental component in ensuring access to quality, safe and effective medical products and globalization of supply chains brings a number of challenges to the pharmaceutical manufacturing and distribution industries and the National Medicines Regulatory Authorities (NMRA’S) regulating them. Ensuring that no weak links exist in the supply chain is critical in protecting patients from unsafe medical products. The risks posed by substandard, falsified, stolen and diverted medical products are well documented. Non-compliance with GDP by just one distributor can lead to a disproportionately large negative impact on public health, including a loss of public confidence in our health systems, health products and healthcare professionals. A well regulated supply chain is the best way of minimizing the risks from these types of products.

The 2-day workshop, held at WHO Collaborating Centre in Hillerød, focused on the interpretation and implementation of the new EU guidelines. WHO/Europe provided an overview of the global situation concerning substandard and falsified medical products and a case study relevant to the region. Delegates also spent a day with the Danish health and medicines authority in discussing the practical application of the new EU directive. This initial workshop will be followed up through exchange of knowledge and information as well as an additional consultation in 2016.