Dutch drugmakers reminded on in-use shelf life of OTC regs requirement

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

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

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

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

Marketing authorization 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.

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).