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April 26, 2021 Life Science Consulting

Understanding Responsible Person and Wholesaler Dealers Authorization

Anders Nyholm Director Quality Compliance

Wholesaling is a key factor for drug manufactures and Marketing Authorization Holders to ensure supply of pharmaceutical products to their customers at pharmacies and hospitals. Wholesaling of pharmaceutical products is done in accordance with the GxP-standard Good Distribution Practice (GDP).

Two of the most important parts of GDP are to maintain the product quality and to ensure product security by minimizing the risk of introducing rogue products in the legal supply chain.

In the European Union (EU) and the European Economic Area (EEA), wholesaling of medicinal products is regulated and requires a Wholesalers Dealers Authorization (WDA). The legal framework for wholesaling of medicinal products is set in the EU Directive 2001/83/EC article 84,  Article 85(b)(3) and EU published guidelines on how the directive should be interpreted. The latest version was published in 2013 and is called Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01), commonly known as the EU-GDP.

EU Directives are not legally binding as EU Regulations are. This mean that each EU/EEA-country can make their own interpretation of the Directive and EU-GDP in their legislation and the competent authorities in each country issue WDAs in their jurisdiction.

All WDA-holders must have a Quality Management System (QMS). The QMS should describe processes to assure GDP critical activities such as holding and transport of products, complaint management, recalls and training are covered. The procedures in the QMS should reflect operating activities of that specific company.

Each WDA has a Responsible Person (RP) named on the license. The RP has the quality oversight of the company’s wholesale operation and has the main responsibility to assure compliance to GDP-regulations and that the quality of the products distributed is maintained. The exact requirements for an RP are set in the national legislation, but in general, it is a degree in Natural Science/Pharmacy and relevant experience from GDP required.

Wholesaling is defined as all activities related to procuring, holding and selling of pharmaceutical products. In todays outsourced supply chain it means that not only companies with physical storage facilities require a WDA. If your company is involved in any kind of buy/sell activity, even if you have outsourced your warehouse to a third-party logistic provider, you will probably need a WDA.

For more information, contact the experts at ProPharma Group.

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