Frequently Asked Questions (FAQ)
Here’s what you need to know about our services, based on the questions we get asked the most.
Can you provide EU GMP certification?
Do I need a warehouse for a wholesale license?
If I export medicine to the EU, will I get an EU GMP certificate?
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.
Where can I find the GMP?
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”
How long does it take to become EU GMP certified?
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.
How can I export medicine to the EU?
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.
Is packaging a distribution or a manufacturing operation?
What is the difference between the Qualified Person and Responsible Person?
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.