GDP
Obtain your GDP licence with guidance from van Rooijen Consultancy
A wholesale licence (GDP licence) is essential in pharmaceutical logistics. This licence is mandatory for companies that store medicines for longer than 72 hours within the European Union. Ian van Rooijen Consultancy guides companies step by step in obtaining this licence and also helps you navigate the complex regulations.
What is a GDP licence (Wholesale Licence)?
A Wholesale Licence, also known as a WDA (Wholesale Distribution Authorisation) or GDP licence, is an official government licence for companies involved in the wholesale or long-term storage of medicinal products.
When is a GDP licence required?
Your company requires a GDP licence if it is based within the EU and stores medicinal products for longer than 72 hours (either itself or via third parties).
When is a GDP licence not required?
Your company does not require a GDP licence if:
- Medicines are stored for less than 72 hours.
- Medicines are stored for less than 72 hours.
- You only offer transport services without storage
- Storage is outsourced and takes less than 72 hours.
How do you obtain a wholesale licence?
Unlike commercial certifications (such as ISO), you cannot purchase a GDP licence. It is granted exclusively by the government. In the Netherlands, Farmatec is the competent authority for pharmaceutical licences. Companies in other EU countries must submit an application to their local authority.
The inspection by IGJ
After submitting the application, the Health and Youth Care Inspectorate (IGJ) will carry out an inspection based on the European GDP guidelines. At the time of inspection, your company must be fully operational—as if you were to start storing or distributing medicines the very next day. The inspectorate will check whether your quality system, procedures and infrastructure meet the requirements. The guidelines can be found in EudraLex Volume 4. If the assessment is positive, Farmatec will be advised to grant the licence. You will then receive it within a few weeks to months. https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en. Bij een positieve beoordeling ontvangt Farmatec het advies om de vergunning te verlenen. U krijgt deze dan binnen enkele weken tot maanden toegekend.
What happens after the award?
- A re-inspection usually follows within approximately one year.
- Upon successful re-inspection, you will receive an official GDP certificate confirming your compliance.
Companies outside the EU
Companies outside the EU cannot apply for a GDP licence within Europe. Local authorities may impose similar requirements, but this falls outside the scope of the European licensing system.
How van Rooijen Consultancy can assist you
- Determining whether your company is eligible
- Submission of the licence application to Farmatec or the competent authority
- Establishing a GDP-compliant quality system
- Staff training and awareness
- Preparation for inspections and audit readiness
- Communication with IGJ and Farmatec
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