11/12 March 2020
The revised Good Distribution Practice Guide in the EU which was introduced in March 2013 was triggered by the so called Counterfeit Directive. This was of course never the official name, but it was the intention of the European Commission to ensure a secure Supply Chain and to prevent illegal/counterfeit medicinal products from entering into the legal supply chain.
A number of cases have been identified where illegal medicinal products have entered the legal supply chain. Moreover, it was recognized that there is a well established (GMP) control when it comes to manufacturing of medicinal products, but once the product has left the facility of the manufacturer, there is little control. Products have been transported and stored, but nearly no pharmaceutical manufacturer seems to be able to monitor the full supply chain. Products may be stored at the airport or in trucks but not always with the necessary controls in place.
As one of the consequences from the Counterfeit Directive an European wide authorisation and monitoring system has been established. Member States are supposed to enter their information relating to the authorisations referred to article 77(4) in the Union Database (EudraGMDP). Each Wholesaler will need a Wholesale Distributor Auhorisation (WDA). Those facilities that have been audited will receive a GDP certificate. It is the intention that the publicly available information about WDAs and GDP certificates will enable the responsible persons to establish a legal supply chain for the products by choosing competent and trustworthy companies.
However, for the time being it is difficult to use the information in the European Database for the purpose of establishing a controlled supply chain. The data in EudraGMDP are currently incomplete and cause some discussions among the stakeholders who access the data. The following information is taken from EudraGMDP on 9 March 2015:
Germany 141 WDAs
Belgium 141 WDAs
Denmark 199 WDAs
Portugal 199 WDAS
Spain 3 WDAs
France 5 WDAs
Sweden 233 WDAs
Netherlands 275 WDAs
Norway 152 WDAs
Malta 67 WDAs
Poland 704 WDAs
United Kingdom 2303 WDAs
It seems to be unlikely that these figures represent the real situation. Still not all data have been entered into the database. This can lead to confusion among stakeholders who access this data. Wholesalers not listed in the database might have problems to convince their customers that they have the necessary authorisation for dealing with medicinal products. The numbers above cause a number of additional questions, e.g. "Why does the UK and Poland issue more WDAs than all other EU states ina total?" Or "Is it logical that Germany has less WDAs than Denmark and Portugal?"
A closer look at the GDP certificates which have been entered into the database even cause more questions. Some figures below:
United Kingdom: 1560 GDP Certificates
Germany 3 GDP Certificates
Austria 383 GDP Certificates
Portugal 198 GDP Certificates
Poland 0 GDP Certificates
Does this mean that Portugal has audited all WDA holders, except for one? How many GDP Certificates might already exist in other countries but have not been entered into the EU Database?
The above figures only represent a snapshot of the current status of EudraGMDP. But 2 years after the EU GDP Guide has been published some more work is needed to make sure that the objectives of the EU Directive will be met.