Transporters of medicine that do not store medicinal products longer than 72 hours on end are not eligible for GDP certification.
The GDP regulatory requirements are enforced by your national regulatory authority. If you are in compliance with the GDP regulations, you will receive a “GDP license”. Officially, this license is called a “Wholesale and Distribution Authorization” – WDA.
The WDA (GDP license) and the associated GDP certificate are the only official license / certificate for a pharmaceutical wholesaler.
Unfortunately, the WDA is not applicable to every type of company involved in the pharmaceutical supply chain. To keep the regulatory burden proportionate to patient risk, EU regulators have chosen to apply the WDA and GDP certificate to organizations that store medicinal products for a period longer than 72 hours on end.
If you transport medicine but do not store them for more than 72 hours on end, you cannot get a WDA (GDP license). You cannot get a GDP certificate.
If you are a distributor / transporter of medicinal products that stores these products for more than 72 hours on end, you are eligible for a Wholesale Distribution Authorization and the associated GDP license.
The GDP guideline stipulates the requirements that you must apply to your business. The GDP guideline can be found on the website of the European Commission, or by Googling: “Eudralex Volume IV Part 1”.
Or follow this link.
Applying the GDP requirements is a time consuming process. You will need to apply strict project management and maintain discipline in standard operating procedure adherence. Staff will need to be trained on the GDP, the quality system must be implemented and there will be a large number of risk assessment activities.
To get a better understanding of the GDP requirements, how to implement them and how to get a GDP license, follow this link.
Transporters of medicinal products are often requested to obtain a GDP certificate by their clients. If you do not store medicinal products for more than 72 hours on end but are still required to get a GDP certificate by your client please take the following checklist into consideration:
Download the document.
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