Licences and certifications
Every licence we hold, and where to check it.
Motagon’s authorisations are published on the European Medicines Agency’s EudraGMDP database. You do not have to take our word for any of this.
| Authorisation | Scope | Held since | Authority | Verify | Certificate |
|---|---|---|---|---|---|
| EU-GMP Part I | Batch record review, quality control and Qualified Person certification and release of finished medicinal products; labelling and secondary packaging | June 2026 | SÚKL | EudraGMDP | |
| EU-GMP Part II | Batch record review, quality control and QA release of medical cannabis as an active substance | 2022 | SÚKL | EudraGMDP | |
| EU-GDP | Wholesale distribution of medicinal products | 2020 | SÚKL | EudraGMDP | |
| Narcotics handling | Handling of addictive substances and preparations | 2020 | Czech Ministry of Health | On request |
Current certificates are available for download above and will be replaced as they are renewed. Search EudraGMDP for “Motagon” to retrieve the GMP and GDP certificates directly from the regulator. Certificate numbers to be added by Motagon.
Why both parts of GMP matter
EudraLex Volume 4 splits Good Manufacturing Practice into Part I, covering finished medicinal products, and Part II, covering active substances used as starting materials. Most operators hold one. Holding both means a single partner can take material in as an API and release it as a dispensable finished pack, without a handover between two companies and two quality systems.
Quality management
Motagon operates a pharmaceutical quality system with a Qualified Person responsible for batch certification, deviation and change control, supplier qualification, and a documented Technical Quality Agreement with every supplier we release against.
Auditing us? Our quality team will host a supplier audit and share the quality manual under confidentiality. Get in touch.