a) Banned product

A product that has been withdrawn from use and/or sale nationally in one or more countries by order of the competent national authority, having regard to its safety in relation to its intended use.

b) Voluntary withdrawal

A product that has been withdrawn from use and/or sale nationally in one or more countries by voluntary action of the manufacturer, having regard to its safety in relation to its intended use.

c) Severely restricted

A product containing:

(i) a substance that is controlled more rigorously than is provided for under the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances or that is subject to analogous control at the national level before it has been considered for international scheduling.

(ii) a substance that may be incorporated in pharmaceutical dosage forms only within the specific limits determined by statute.

(iii) a substance that is approved by a competent national authority and is subjected to restrictions that exclude its use in a substantial proportion of the potential target population of patients having regard to its safety. A substance which from the outset has been severely restricted in its indications having regard to the known balance of safety and efficacy is excluded.

d) Not approved

A product that has been formally submitted for registration by a manufacturer to a national competent authority and which has been rejected on grounds of safety.