Medicines, vaccines and advanced therapies

TOPIC

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.



Aggiornamento e revisione di alcuni testi della Farmacopea Ufficiale XII edizione

La Farmacopea Ufficiale Italiana XII edizione è stata aggiornata, nei testi nazionali Tabelle e in alcuni testi revisionati e nuovi della Farmacopea Europea, con la pubblicazione in Gazzetta Ufficiale del Decreto 17 maggio 2018 (GU 6 giugno 2018, n. 129) e del Decreto 24 luglio 2018 (GU 14 agosto 2018, n. 188).

Sono testi generali e testi specifici rivolti ai farmacisti, nella loro attività di dispensazione dei medicinali e di allestimento di preparati magistrali e in scala ridotta.

Tali testi sono anche rivolti all’industria farmaceutica.


Dipartimenti/Centri/Servizi

National Centre for Control and evaluation of medicines

Target

Citizen Healthcare professional Information specialist

Content type

Document

Topics

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