Medicines, vaccines and advanced therapies


Medicines, vaccines and advanced therapies

Official pharmacopoeia of the Italian Republic

The quality of substances for pharmaceutical use must be assessed on the basis of continuously updated standards regarding the scientific and technological process, published in the national pharmacopoeia to guarantee their safety of use and efficacy.

For the European Union countries, the pharmacopoeia is made up of texts in force by the European Pharmacopoeia and by any national pharmacopoeias such as, in Italy, the Official Pharmacopoeia and its Secretariat.

The Secretariat is a technical structure that coordinates the activities related to the revision and elaboration of the Official Pharmacopoeia and the transposition of the European Pharmacopoeia. It also constitutes the national interface with the European Pharmacopoeia and with the European Directorate for the Quality of Medicinal Products (EDQM) for all the activities of the European Pharmacopoeia Commission and its expert groups.

Gruppi di Esperti e Gruppi di Lavoro della Farmacopea Europea

La Commissione della Farmacopea Europea per l’elaborazione e la revisione dei testi della Farmacopea Europea si avvale di Esperti designati, riuniti in Gruppi di Esperti e in Gruppi di Lavoro, questi ultimi in caso di argomenti specifici.

I testi elaborati oppure in revisione, sono pubblicati in Pharmeuropa, pubblicazione online dell’European Directorate of Medicines & Healthcare (EDQM), per informazione e per commenti da parte dei diversi utilizzatori della Farmacopea.

I testi così elaborati sono poi sottoposti all'approvazione della Commissione per la successiva pubblicazione.


National Centre for Control and evaluation of medicines


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Medicines, vaccines and advanced therapies Official pharmacopoeia of the Italian Republic