Reply To: Retest Dating Assignment
January 31, 2020 at 2:20 pm– Hope this answers your question: The guidance is clear on expiry dating format from Annex 13:
Labelling
26. Table 1 summarises the contents of Articles 26-30 that follow. Labelling should comply with the requirements of Directive 2003/94/EC. The following information should be included on labels, unless its absence can be justified, e.g. use of a centralised electronic randomisation system:
(j) period of use (use-by date, expiry date or re-test date as applicable), in month/year format and in a manner that avoids any ambiguity.
– The key point here is a format that avoids ambiguity. As you only have stability until the 10th of April 2022, you have no choice but to list your expiratory as March 2022 as the reg only allows month and year and you have no gap stability to support to the end of the month.
Steve
