No Monitoring needed if there are no Storage Conditions on the Outer Packaging?

Recommendation

2/3 March 2022

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"Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging?" This question was the first GDP-related question being published along with an answer in the Q&A Section of EMA's website.

And EMA gives a clear answer: "No".

The justification is based on the Guideline on declaration of storage conditions (CPMP/QWP/609/96 Rev. 2). If a marketing authorisation holder (MAH) does not want to include storage conditions on the labelling, the MAH at least will need to provide stability data for storage conditions at 25°C / 60% relative humidity (RH), or 30°C / 65% RH (long term) and 40°C / 75% RH (accelerated). This stability data is based on the temperature and humidity conditions of climate zone I (temperate) and II (Mediterranean/subtropical) in Europe.

As a consequence, controls should be in place to maintain conditions relevant to these climate zones, if no labelling statement is given. This means that the temperature should be monitored during storage and transport.