EMA: Update on GDP-Q&As for Broker Activities
The EMA added two good distribution practice (GDP) questions to its Q&A section on GMP/GDP topics in early January 2023. They should clarify how the GDP rules apply to brokers operating outside the European Economic Area (EEA).
The new questions address whether a broker can handle activities between contracting parties outside the EEA and whether he can also have broker activities for medicinal products without a marketing authorisation in the EEA but with authorisation outside the EEA.
The answer to both questions is no. As an explanation, the EMA referred to its 2013 guidelines on GDPs (paragraphs 10.4 v and iv). The guidelines require suppliers and customers to be located in the EEA. Brokerage activities between suppliers and customers outside the EEA fall outside the scope of EU legislation. Similarly, a medicinal product must be authorised in at least one EEA country for the regulations to apply.
Source:
EMA: Guidance on good manufacturing practice and good distribution practice: Questions and answers
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