For those of you who are not aware EUDRAGMDP is the new, centralised depository for the National Competent Authorities in Europe for manufacturing, import and wholesale distribution authorisations, and GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) certificates.
The public version of the EUDRA GMDP database is a useful tool for anyone involved in wholesale dealing as it allows you to search for the compliance documents (or non-compliance in some cases) of your customers and suppliers.
We have had varying experiences with this tool, and on a number of occasions had significant difficulties in finding specific businesses… even when we had their full names, addresses and WDA numbers. Peer comments about the EUDRA GMDP site varied, but were often impolite due to frustrations.
We then discovered that Sean Kaiser, Data Processing Manager at the MHRA, had posted a useful guide which is available for free download HERE
The first thing we noted was the ability to use an asterisk * as a “Wild card” and this makes using the site significantly more simple, and when we searched for three of our customers we found all of them.
So, how does this help you?
As you will be aware, if you are to be compliant with GDP you need to ensure that your suppliers and customers are licenced and bona fide, and not on the MHRA suspended licence list, and if you fail to carry out your regular bona fides checks you will fall short during your regulatory inspection. EUDRAGMDP is your free resource to download GDP (non) compliance certificates and this helpful guide is how you can navigate the somewhat clunky system.
Still need help with bona fides checks?
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Important Note: The MHRA have not endorsed this post, we merely wish to share their useful information for the good of the patient and to assist our network and readers.
13 Mar 2017
24 Feb 2017