Different Storage Conditions and Stability Characteristics for Generics and Innovator Product: Is that allowed?

Recommendation

17/18 September 2024

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It may happen - in the development of generic medicinal products - that the in-use stability properties or the storage conditions deviate from those of the innovator product. The question whether this is basically allowed or only allowed with restrictions in the context of the application for authorisation of a generic product has been answered by the EMA and put on its updated Q&As webpage. The answer to the following two questions was published as supplement to the Q&As:

• "Is it allowed that the in-use stability of one product deviates from other authorised products (e.g. regarding storage time, storage conditions)?
• Is it allowed that the storage condition of one product deviates from other authorised products (e.g. storage in refrigerator versus storage at temperatures not exceeding 25°C)?"

The EMA clearly states in the answer to both questions "each product will be assessed on its own merits". At the same time, the EMA takes into consideration whether differences in in-use stability and/or storage conditions potentially could lead to detrimental medication errors (wrong dosing). In such a case, the EMA cannot accept the differences and will delay the treatment of the application until the problem has been solved. In its answer, the EMA refers to a position paper of the CHMP which discusses medication errors caused by differences between generics and innovator products. This position paper is dated 30 May 2013 and its title is "Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures". The different in-use stability and storage conditions aren't explicitly addressed in the document. That's the reason why the EMA felt compelled to clarify those questions in the Q&As.