Change of legal status of supply
There is no variation procedure defined in the classification guideline for a national change to the legal status of supply (only for centrally authorised products). A change from PO to OTC (or vice versa) or from PH to PDO (or vice versa) is implemented via a type II variation. Category C.I.z can be used.
There is also no variation procedure defined in the classification guideline for a national change of the legal status of supply to GS (only for centrally authorised products). A request can be submitted using the subject line “Request for GS status”. The change of the legal status of supply to GS is implemented via a type II variation or a type IB variation, depending on whether the active ingredient is already on the list with GS status.