Approval of the review of the “Resolution on the classification of medicinal products for the purpose of dispensation” (CM / Res (2018) 1) by the Committee of Ministers of the European Council takes a step towards.

Recommends that the governments of States Parties to the Convention on the Elaboration of a European Pharmacopoeia:

  1. provide information on a regular basis on the national legal classification of medicines as regards their supply for inclusion in the Melclass database;
  2. implement the recommendations for the classification of active substances depending on the supply conditions of the medicines which contain them, as listed in the Melclass database;
  3. align their regulations and practices in accordance with the general provisions set out below. These general provisions should not prevent governments from maintaining or adopting more specific rules on the classification of medicines as regards their supply.

Harmonized classification for consumer safety

Currently, the classification of some medicinal products, both on prescription and for free sale, can differ between different countries participating in the European Pharmacopoeia convention. Hence the initiative put in place by the Council of Europe to achieve greater harmonization of the framework, with consequences on the safety of the use of different classes of drugs by European citizens.

Classification criteria

The different countries are also called to implement recommendations on the classification of pharmacologically active substances with respect to the dispensing conditions of the medicines containing them, in accordance with the criteria described in the Melclass database. National legislation and practices will need to be adapted accordingly, with freedom for individual countries to maintain or adopt more specific rules.
The resolution also indicates the general criteria for the creation and periodic updating of the lists of active substances, which only apply to medicinal products for human use.
The lists of medicines must be created considering whether they are provided to patients on prescription or as OTC medicines, as well as all risks to human health, both direct and indirect and also in case of off-label use.

Products subject to prescription

The active substances must be classified according to the ATC criteria of the World Health Organization, using a nomenclature according to the INN system of the International Non-Proprietary Names.

List 1 refers to medicines that can not be dispensed again without specific indication from the doctor, while list 2 lists the products that can be supplied repeatedly. T

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