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GDP for transportation companies of medicinal products (without storage)

GDP for transportation companies of medicinal products (without storage)
1.

Can I get a GDP certificate as a transporter of medicinal products?

Short answer:

Transporters of medicine that do not store medicinal products longer than 72 hours on end are not eligible for GDP certification.

Long answer:

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.

2.

I store medicine longer than 72 hours how do I 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.

3.

I do not store medicine longer than 72 hours what should I do?

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:

Notify your client of the 72-hour requirement
Dutch authorities maintain a document containing questions and answers about the GDP regulatory requirements. Refer your client to the document. It’s linked below. Your client may waive the request for an official GDP certificate.

Download the document.

Discuss voluntary GDP implementation with your client
Even though you cannot get a government GDP certificate nothing stops you from voluntarily implementing the GDP guideline. Verify with your client if the certificate can be replaced by implementing the GDP, without a government GDP certificate. The client can check your GDP compliance instead of the government.
Go for commercial GDP certification
Some consultancy companies offer a commercial GDP certificate. This does not carry any official weight, but it may satisfy your client’s need. You will need to implement all GDP requirements after which a pharmaceutical consultancy organization checks and certifies you.
Do not apply for a WDA license (GDP license)
You are not eligible for a WDA (GDP license / groothandelsvergunning). Applying for a license carries costs which will be payable to the government. Save money and time, explore alternative options.
Discuss your case with a GDP consultant
Do you feel like you need advice on implementing the GDP guideline? Contact a GDP consultancy organization or GDP consultant. This may provide you with additional insights and gives you a clear picture of the cost of implementing GDP.
Jaap Koster
Jaap Koster
pcs-nl.com

Jaap Koster has 39 years of experience in the pharmaceutical industry in North- and South America, Asia, Africa and Europe. Jaap is the CEO of PCS.

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