Glossary




ATC
Anatomical Therapeutic Chemical (ATC) classification

CD-P-PH/PHO
Committee of Experts on the Classification of Medicines as Regards their Supply

EDQM
European Directorate for the Quality of Medicines and HealthCare (Council of Europe)

Exemptions from List I and List II
Depending on the conditions of use of the medicine, active substances contained in prescription medicines may also be contained in medicines classified under the same ATC code but which are not subject to prescription. Under certain circumstances, exemptions from the prescription requirement may be set out in the Melclass database: a) in respect of a low dosage or concentration of the active substances and/or the therapeutic indications of medicines in which they are contained; b) according to the route of administration and the composition of the medicine; c) according to the total amount of the medicine per container

INN
International Nonproprietary Name

List I
The supply of a medicine containing one of the substances in this list should not be renewed without the prescriber having so specified - this classification applies to active substances of medicines indicated for conditions calling for short-term treatment and/or for which continuous medical supervision is necessary, either because of potential undesirable effects or to check the efficacy of treatment; or active substances of medicines administered for diagnostic purposes; or active substances with a new pharmacological mechanism of action

List II
The supply of a medicine containing one of the substances in this list can be renewed - this classification applies to active substance in medicines indicated for conditions for which the patient may continue the regular or intermittent treatment without new medical advice, and for which well-known undesirable effects do not call for frequent clinical examination

MA Number
Marketing authorisation number

MDD
Maximum daily dose

MQP
Maximum quantity of active ingredient per pack

MS
Maximum strength

Not subject to prescription
Active substance of a medicine that does not require a medical prescription

Not subject to prescription - Supply through general sales
Active substance of a medicine that does not require a medical prescription and can be bought from general retail outlets (e.g. supermarkets, petrol stations, newsagents)

Not subject to prescription - Supply through pharmacies only
Active substance of a medicine that does not require a medical prescription and can be bought only from pharmacies and under the supervision of a pharmacist

POM
Prescription-only medicine - active substance of a medicine that has to be prescribed by a medical doctor or other authorised healthcare professional and has to be dispensed from a pharmacy or from another specifically licensed place

Resolution CM/Res(2018)1
Resolution CM/Res(2018)1 on the classification of medicines as regards their supply (superseding Resolution ResAP(2007)1 on the classification of medicines as regards their supply) (adopted by the Committee of Ministers on 10 April 2018 at the 1313th meeting of the Ministers' Deputies)