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Frequently asked questions.

Here’s what you need to know about our services, based on the questions we get asked the most.

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GMP Questions

Questions about the Good Manufacturing Practices (GMP) regulatory requirements.

Although we cannot certify you ourselves, we can provide support to help you achieve EU GMP certification. No commercial organization can provide EU GMP certification. Only competent authorities can. In the Netherlands, the competent authority is the Inspectie voor de Gezondheidszorg en Jeugd (IGJ) –

This is different for every company, it depends highly on the complexity of the product(s) you produce / distribute, your facilities and your equipment.

As a general rule of thumb, it takes about 9 to 12 months for greenfield projects and up to 24 months for brownfield projects. If you already have U.S. FDA GMP or WHO GMP implemented, these timelines may be significantly shorter.

Not necessarily. It is a common misconception that you need an EU GMP certificate to export medicine to the EU. The European Union employs a system that reduces the workload of national competent authorities.

It would be nearly impossible to regularly check all companies that export medicine to the EU worldwide. You will always be audited by your importer in the EU against the EU GMP. If you pass the audit, they may import your product.

This does not imply you will be inspected by an EU government. Depending on the importance and risk of your product, you may be audited by your importer and by an EU GMP inspector, but this is not always the case.

Only if you have been inspected by an EU GMP inspector can you get an EU GMP certificate. There is no way to influence the government’s decision whether or not to inspect you.

You are allowed to export medicinal products to the European Union if you meet a number of conditions. The two most important conditions are:

1. You have the EU GMP implemented, this can be verified.

2. You have an importer in the EU, this can be any company with a manufacturing and import authorization located in the EU that wants to import your product. For more requirements, contact us.

Although packaging may seem like an activity that belongs to the distribution side of things, it’s a manufacturing operation as far as the GMP is concerned. This also applies to labelling.

Other Questions

Questions related to GDP, pharmaceutical wholesaling or other topics that are not GMP related.

The Qualified Person releases medicine for the manufacturer. The QP checks lab results, batch documentation and checks the medicinal product against the dossier. With the QP’s approval, a product may be sold on the market.

The Responsible Person determines if products may be released from the warehouse, for the distributor. A QP certifies production, the RP certifies that the product has been stored and handled according to it’s specifications.

If the Responsible Person can verify that these conditions have been met, the product may be distributed. If not, the product remains in the warehouse’s quarantine section.

You need a warehouse, but it doesn’t have to be your own warehouse. Many companies applying for a wholesale (WDL) license have a third party logistics organization that perform the warehousing function.

For the EU GMP – Google: “Eudralex Volume 4”

For the U.S. FDA GMP – Google: “21 CFR part 211”

For the WHO GMP – Google: “WHO TRS GMP”

For the PIC/s GMP – Google: “PICs gmp guide”

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