The original guidance emphasised the difficulty of predicting product usage conditions and placed responsibility on users to maintain product quality. The recent Q&As expand on the original guidance, suggesting that in-use shelf life should be supported by stability tests, with companies providing data on product-specific scenarios.

The communication of shelf-life information should adhere to the guidance text, clearly stating in-use storage time and conditions and emphasising user responsibility. The EMA also provides guidance on wording for different product types and a flow chart to assist companies in determining appropriate product information texts for their products.

Source:

EMA Quality Q&As