The list of active substances in products that may qualify for sale general sale (GS list) was updated by the MEB on 30 May 2018. This is version 15 of the list.
If a particular active substance does not meet the conditions listed on the GS list, this does not mean that a medicinal product containing this active substance can never obtain GS status. Only the accelerated, administrative completion procedure for obtaining GS status of supply is impossible in such cases.
A specific excipient used in a medicinal product with an active substance on the GS list may be reason enough to deviate from the accelerated administrative procedure. This may relate to the amount of a specific excipient used or specific properties of the excipient or the relative novelty of the excipient such that more extensive assessment is required.
The marketing authorisation holder is free to submit a variation request (Type II variation) for a change to the legal status of supply to GS in such cases. This request must be supported by scientific data. Current legislation regarding legal status of supply must be taken into consideration. Variation requests are assessed by the MEB; if approved, the legal status of supply of GS may be assigned to the marketing authorisation for which the Type II variation was submitted.