Update of the EMA Q&As on GDP Requirements

The European Medicines Agency (EMA) provides answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) on its website, which have been compiled and agreed by the GMP/GDP Inspectors Working Group.

In January 2023, the list was updated. Three new questions related to GDP requirements were added.

Monitoring of Storage Conditions

The first question is as follows:

  • "Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging?"

The question is answered with a clear "No". Marketing authorisation holders have to provide stability data to justify not including a statement in the medicinal product labelling. Such stability data is generated according to the conditions of climate zone I and II. The EMA writes that "no labelling statement means that controls should be in place to maintain conditions relevant to climate zones I and II."

Activities of Brokers

The other two questions relate to the activities of brokers with parties outside the EEA:

  • "May a broker have broker activities between parties outside the EEA?"
  • "May a broker have broker activities for medicinal products without a marketing authorisation in the EEA (but with a marketing authorisation in a county outside the EEA)?"

Referring to the requirements of the EU GDP Guidelines, these two questions are also answered with a clear "No".

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