Anatomical Therapeutic Chemical (ATC) classification

Committee of Experts on the Classification of Medicines as Regards their Supply

European Directorate for the Quality of Medicines and HealthCare

Exemptions from List I and List II
For certain active substances exemptions from the “prescription only” requirements may appear in List I and List II. Their conditions of supply are indicated in Appendix III of ResAP(2007)1.

International Nonproprietary Name

List I
Active substance of a medicine that can only be supplied on a medical prescription. The supply of a medicine containing this active substance may only be repeated if the prescriber specifies so on the prescription.

List I (1)
Active substances of a medicine indicated for conditions calling for short-time treatment and/or for which continuous medical supervision is necessary

List I (2)
Active substance of a medicine administered for diagnostic purposes

List I (3)
Active substance of a medicine with a new pharmacological mechanism of action

List II
Active substance of a medicine indicated for conditions for which the patient may continue the regular or intermittent treatment without a new medical advice, and for which well-known side effects do not call for frequent clinical examination

MA Number
Marketing authorisation number

Maximum daily dose

Maximum quantity of active ingredient per pack

Maximum strength

Active substance of a medicine that does not require a medical prescription (over-the-counter medicine)

Prescription-only medicine

Resolution ResAP(2007)1 on the classification of medicines as regards their supply (adopted by the Committee of Ministers on 12 April 2007 at the 993rd meeting of the Ministers’ Deputies)