Wholesale distribution authorisation

Pharmaceutical companies or marketing authorisation holders who market medicinal products which have been made by a third party require a wholesale distribution authorisation, or WDA. We help our clients in obtaining their licence.

The requirements for obtaining a wholesale distribution authorisation within the meaning of Article 76 et seq. of EU Directive 2001/83/EC include:

  • Pharmaceutical quality management in accordance with the EU GDP Guideline
  • Adequate premises and facilities for proper storage and distribution
  • Providing a person to be responsible for wholesale distribution (responsible person for wholesale distribution)

We check whether the requirements for obtaining a wholesale distribution licence have been met and whether GDP rules are being followed, plus we provide support if any preparatory work is still needed. We compile the necessary documents, update and/or develop the quality assurance system (including SOPs), create documentation that is precise down to the batch and much more. We are also happy to handle contacting the authorities responsible for licensing and help oversee their (approval) inspections.

Responsible person for wholesale distribution

It is not economically feasible – or necessary – for every pharmaceutical company to provide one or more in-house responsible person(s) who can be reached 24 hours a day. Diapharm can act as the responsible person for wholesale distribution on their behalf. Many pharmaceutical companies take advantage of this service.

Did you know? Pharmaceutical companies with their own import and/or manufacturing authorisation that additionally distribute other manufacturers’ medicinal products as part of a co-marketing agreement, for example, also require a wholesale distribution authorisation to do so.