Slide background
Certifico: Informazione tecnica HSE / 25° anno

/ Documenti disponibili: 43.732
/ Totale documenti scaricati: 30.866.013

Vedi Abbonamenti, Prodotti tecnici e Software 2025

* Dati in real-time da Aprile 2014 alla data odierna.
 
Slide background
Slide background
Certifico 2000/2024: Informazione Utile




/ Documenti disponibili: 43.732 *

/ Totale documenti scaricati: 30.866.013 *

Vedi Abbonamenti, Prodotti e Software 2024


* Dati in real-time da Aprile 2014 alla data odierna.
Slide background
Certifico 2000/2024: Informazione Utile

/ Documenti disponibili: 43.732 *

/ Totale documenti scaricati: 30.866.013 *

Vedi Abbonamenti Promo 2023


* Dati in real-time da Aprile 2014 alla data odierna.
Slide background
Slide background
Certifico 2000/2023: Informazione Utile

/ Documenti disponibili: 43.732 *

/ Totale documenti scaricati: 30.866.013 *


Vedi Abbonamenti Promo 2023


* Dati in real-time da Aprile 2014 alla data odierna.
Slide background
Certifico 2000/2023: Informazione Utile

Slide background
Certifico 2000/2023: Informazione Utile

Slide background
Certifico 2000/2023: Informazione Utile

Abbonamenti Promo fino al 20 Agosto - 20% ticket "CERTIFICO20"

Vedi Abbonamenti Promo: 2X, 3X, 4X, Full | 2023
Slide background
Certifico 2000/2023: Informazione Utile

Abbonamenti Promo fino al 20 Agosto - 20% ticket "CERTIFICO20"

Vedi Abbonamenti Promo: 2X, 3X, 4X, Full | 2023
Slide background
Certifico 2000/2023: Informazione Utile

/ Documenti disponibili: 43.732 *

/ Totale documenti scaricati: 30.866.013 *

Vedi Abbonamenti Promo 2023

* Dati in real-time da Aprile 2014 alla data odierna.
Slide background
Certifico 2000/2022: Informazione Utile

/ Documenti disponibili: 43.732 *

/ Totale documenti scaricati: 30.866.013 *


Vedi Abbonamenti Promo 2022

* Dati in real-time da Aprile 2014 alla data odierna.
Slide background
Certifico 2000/2022: Informazione Utile

Tutti i Software, Prodotti e Documenti Tecnici presenti sono elaborati direttamente

o selezionati su Norme Tecniche & Standards riconosciuti.


Vedi Abbonamenti Promo: 2X, 3X, 4X, Full | 2022
Slide background
Certifico 2000/2021: Informazione Utile

Tutti i Software, Prodotti e Documenti Tecnici presenti sono elaborati direttamente

o selezionati su Norme Tecniche & Standards riconosciuti.

Vedi Abbonamenti Promo: 2X, 3X, 4X, Full | 2021








Europe, Rome

IDMP Identification of Medicinal Products standards: revised 2017

ID 4836 | | Visite: 5583 | News generaliPermalink: https://www.certifico.com/id/4836

IDMP Identification of Medicinal Products standards: revised 2017

Update 26.10.2017 

ISO/TC 215 Health informatics

Revised IDMP standards to improve description of medicinal products worldwide

A series of standards called IDMP (Identification of Medicinal Products) is under revision and will bring a host of benefits to patients and the healthcare community. Implementing these standards should simplify the exchange of information between stakeholders and enhance the interoperability of systems in the medical field.

IDMP standards and technical specifications, comprising ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844, support the activities of medicines agencies worldwide. These cover a variety of regulatory activities related to the development, registration and life-cycle management of medicinal products, as well as pharmacovigilance and risk management.

Christian Hay, Senior Consultant Healthcare for GS1 Global Office and Convenor of working group 6, Pharmacy and medicines business, of ISO technical committee ISO/TC 215, Health informatics, explains: “IDMP standards are essential for the world’s increasingly integrated healthcare. They provide the precise architecture for the computerization of information on medicinal products all around the world. When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records.”

To meet the primary objectives of the regulation of medicines and pharmacovigilance, the reliable exchange of medicinal product information in a robust and consistent manner is essential. IDMP standards fully support this and that is why a revision of the standards was deemed opportune.

ISO IDMP standards cover the following aspects to describe a medicinal product: 

  • Medicinal product name
  • Ingredient substances
  • Pharmaceutical product (route of administration, strength)
  • Marketing authorization
  • Clinical particulars
  • Packaging
  • Manufacturing

“The revision has become necessary as a consequence of the development of IDMP implementation guides (which take the form of four CEN1) ISO technical specifications). The overall standard has not really changed but has gained in usability for implementers. By developing implementation guides, it has been possible to shift some detailed information from the standard itself to its corresponding implementation guide,” says Christian Hay.

“By publishing the ISO IDMP standards in 2012, the community has been able to understand a potential fundamental change in each respective data model – which are currently very diverse. Having learned from users’ reactions, the IDMP project leaders have initiated an ambitious standards development programme, which consists of working on implementation guides (namely, the four CEN ISO technical specifications). Now, one can expect the creation of educational material and a uniform implementation both on the part of the manufacturer and the regulator. In parallel, IDMP provides a basis for existing or new IT solutions, such as prescriptions, medication reports, medicinal product dictionaries for clinical use, and more,” he adds.

Using ISO IDMP within regulatory activities brings benefits to regulators, industry and, ultimately, patients. “The trend towards global standards continues to increase. I cannot imagine the world without IDMP, whose implementation programme is going to last several years. Without IDMP, the existing information fragmentation by country or region would cause increasing risks to patients globally – not only those who travel, but those who are faced with mobile health or because of the globalization of supply chains,” explains Christian Hay.

ISO IDMP standards were developed by ISO technical committee ISO/TC 215, Health informatics, whose secretariat is held by ANSI, ISO’s member for the USA. It is now available from your national ISO member or through the ISO Store.

https://www.iso.org/news/ref2234.html

IDMP Identification of Medicinal Products Standards:

ISO 11615:2017
Health informatics
Identification of medicinal products
Data elements and structures for the unique identification and exchange of regulated medicinal product information

ISO 11616:2017
Health informatics
Identification of medicinal products
Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

ISO/DIS 11238 [Under development]
Health informatics
Identification of medicinal products
Data elements and structures for the unique identification and exchange of regulated information on substances

ISO/TS 20451:2017
Health informatics
Identification of medicinal products
Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

ISO/TS 20443:2017
Health informatics
Identification of medicinal products
Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information

ISO/TS 19844:2016
Health informatics
Identification of medicinal products
Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances

Fonte: ISO 

Tags: Normazione Norme ISO

Ultimi inseriti

Giu 30, 2025 29

Decreto-Legge 30 giugno 2025 n. 96

in News
Decreto-Legge 30 giugno 2025 n. 96 ID 24200 | 30.06.2025 Decreto-Legge 30 giugno 2025 n. 96 Disposizioni urgenti per l'organizzazione e lo svolgimento di grandi eventi sportivi, nonche' ulteriori disposizioni urgenti in materia di sport. (GU n.149 del 30.06.2025) Entrata in vigore del… Leggi tutto
Giu 30, 2025 30

Decreto 10 aprile 2025 n. 94

in News
Decreto 10 aprile 2025 n. 94 ID 24198 | 30.06.2025 Decreto 10 aprile 2025 n. 94 Regolamento recante i criteri per l'accertamento della disabilita' connessa ai disturbi dello spettro autistico, al diabete di tipo 2 e alla sclerosi multipla, applicabili nella valutazione di base nel periodo di… Leggi tutto
Giu 30, 2025 125

Decreto 27 maggio 2025

Decreto 27 maggio 2025 / Stazioni di prova per i veicoli a temperatura controllata (ATP) ID 24195 | 30.06.2025 Decreto 27 maggio 2025Modifica del decreto 22 dicembre 2022, inerente alle modalità di riconoscimento di stazioni di prova per i veicoli a temperatura controllata (ATP) esterne… Leggi tutto
Giu 30, 2025 78

Decisione 2008/823/CE

Decisione 2008/823/CE ID 24194 | 30.06.2025 Decisione 2008/823/CE della Commissione, del 22 ottobre 2008, che modifica la decisione 95/319/CE che istituisce un comitato degli alti responsabili dell'ispettorato del lavoro (Testo rilevante ai fini del SEE) (GU L 288 del 30.10.2008)… Leggi tutto
Giu 30, 2025 73

Decisione 95/319/CE

Decisione 95/319/CE / Comitato degli alti responsabili dell'ispettorato del lavoro ID 24193 | 30.06.2025 Decisione 95/319/CE della Commissione, del 12 luglio 1995, che istituisce un comitato degli alti responsabili dell'ispettorato del lavoro (GU L 188 del 9.8.1995) Modifiche:- M1 Decisione… Leggi tutto

Ultimi Documenti Abbonati

ECHA compendium of analytical methods
Giu 27, 2025 215

ECHA compendium of analytical methods for enforcing REACH restrictions - Ed. 3.0 2025

ECHA compendium of analytical methods for enforcing REACH restrictions - Ed. 3.0 2025 ID 24178 | 27.06.2025 / Attached ECHA has updated its compendium of analytical methods to help authorities to enforce and companies to comply with REACH restrictions. The compendium consists of a collection of… Leggi tutto
Giu 26, 2025 341

Circolare Ministero dell’Interno n. 19441 del 25/06/2025

Circolare Ministero dell’Interno n. 19441 del 25/06/2025 ID 24173 | 26.06.2025 / In allegato Ministero dell’InternoLegge 25 novembre 2024, n. 177 recante “Interventi in materia di sicurezza stradale e delega al Governo per la revisione del codice della strada, di cui al decreto legislativo 30… Leggi tutto