At the present time, a reference standard is withdrawn from the catalogue either on the date that a revised monograph which no longer refers it to becomes applicable, or the date on which a monograph is officially withdrawn from the European Pharmacopoeia.

A number of users have informed us that regulatory requirements in their country permit the use of these reference standards (and therefore the corresponding monographs) even after their official withdrawal date. To help these users, the EDQM has decided to modify its withdrawal policy.

Therefore, stocks permitting, sale of these reference standards will continue for 6 months after the official withdrawal date. Similarly, they will remain in the catalogue for a period of 12 months to allow users to print the Batch Validity Statement (BVS) and/or finalise the necessary procedures for controlled substances.

 

Example:

Fluocortolone pivalate CRS (F0230000) is used in monograph 1212.

The revised monograph enters into force on 01/04/2020.

 

Current situation:

Reference standard F0230000 would be withdrawn from sale on 01/04/2020.

 

New policy:

Reference standard F0230000 will be available for purchase until 01/10/2020 (01/04/2020 + 6 months) and will feature in the catalogue until 01/04/2021 (01/04/2020 +1 year).

 

Note: although it will still be listed in the catalogue until 01/04/2021, it will not be possible to order the reference standard after 01/10/2020.

This standard will thus have an end of validity on 02/04/2021. At this date, it will no longer be displayed in the catalogue and therefore can no longer be used.

 

This policy will be applied from the application of supplement 10.2 (01/07/2020).