Last call for marketing authorisation holders to submit information about in-use shelf life of OTC medicinal products

Marketing authorisation holders are obliged to include information about the in-use shelf-life of OTC medicinal products in the product information. As a marketing authorisation holder, you must have stated to the Medicines Evaluation Board (MEB) no later than 30 September 2017 how you intend to comply with this policy in respect of your OTC medicinal products.

The MEB published the new policy on including information about in-use shelf life of OTC medicinal products (MEB 46) on 30 September 2016.

What you need to do

Marketing authorisation holders are obliged to state to the MEB when and how they intend to comply with this policy in respect of their products, if they have not yet done so. Please send an e-mail to this end to case@cbg-meb.nl no later than 30 September 2017, with the subject: case number 610886.

The MEB may grant postponement to marketing authorisation holders to carry out a stability study to collect information about these products.

The MEB also accepts promises from marketing authorisation holders to submit the information requested no later than a few months before a product is introduced on the market.

Marketing authorisation holders had been given until the end of March 2017 to modify the product information by submitting a variation or a notification. However, with regard to a part of the products, no information about the listing of the in-use shelf life has yet been submitted.

Standard policy

The policy of listing the in-use shelf life on the packaging of OTC medicinal products is now standard policy. It will be processed in the following amendment of the Labelling Policy (MEB 6).