02/14/2023

The European Medicines Agency (EMA) Good Manufacturing Practice Frequently Asked Questions (FAQ) webpage offers guidance on good manufacturing practice (GMP) and good distribution practice (GDP). Previous revisions in February and October 2022 were relating to veterinary medicinal products.

Two questions were added to the “GMP Requirements” section in January 2023 relating to the “Good Distribution Practice of medicinal products for human use” guidance from 2013.

Question 2: “May a broker have broker activities between parties outside the EEA?”

Answer Summary: Both suppliers and customers should be in the European Economic Area (EEA). Supplying wholesale distributors need a distribution authorization, supplying manufacturers or importers need a manufacturing authorization, and customers need to be authorized to supply medicinal products in a Member State.

Question 3: “May a broker have broker activities for medicinal products without a marketing authorization in the EEA but with a marketing authorization in a country outside the EEA?”

Answer Summary: The broker needs to have a marketing authorization for the medicinal product in at least one EEA Member State to broker in the EEA.

Following GMP ensures drugs are consistently produced and controlled per quality standards, thus ensuring drugs are safe and effective for human use. Likewise, following GDP ensures the quality and integrity of drugs throughout the supply chain. In the U.S., Current Good Manufacturing Practices (CGMP) are a group of regulations that describe requirements for drug manufacturers and includes GDP.

- The Clinical Pathways Team

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