![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/pharma-regulations.jpg?w=1024)
Réglementation Pharmaceutique Mondiale
L’une des premières réglementations pharmaceutiques a été mise en œuvre par la Turquie en 2009. Depuis, de nombreux pays ont suivi et mis en œuvre diverses réglementations pour la sérialisation et l’agrégation des produits pharmaceutiques. Chez Laetus, nous avons soutenu nos clients dès le début, en mettant en œuvre des solutions innovantes pour assurer leur conformité.
Le graphique ci-dessus met en évidence les exigences réglementaires récentes et à venir.
La section suivante énumère tous les pays qui ont mis en place des réglementations pour la sérialisation et l’agrégation (un PDF peut être téléchargé au bas de cette page) :
Algeria ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/algeria.png)
Ministry of Health, Population and Hospital Reform (MSPRH)
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | Planned for 2025 |
Click here to go to local authority.
Argentina ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/argentina.png)
Ministry of Health of the Argentine Republic (ANMAT)
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2023 |
Click here to go to local authority.
Australia ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/australia.png)
Department of Health and Aged Care
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2023 |
Click here to go to local authority.
Bahrain ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/bahrain.png)
National Health Regulatory Authority (NHRA)
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 31 December 2019 |
Aggregation
Data carrier | GS1 128 |
Deadline | 01 September 2021 |
Click here to go to local authority.
Brazil ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/brazil.png)
Brazilian Health Regulatory Authority (ANVISA) RDC 157 / 2017
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(713) – NHRN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 April 2022 |
Aggregation
Data elements | AI(00) – SSCC |
Data carrier | GS1 128 |
Deadline | 01 April 2022 |
Click here to go to local authority.
Canada ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/canada.png)
Canadian Institute for Safe Medication Practices (ISMP)
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 31 December 2023 |
Serialization
Data elements | optional AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 31 December 2023 |
Click here to go to local authority.
Chile ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/chile.png)
Ministerio de Salud, Sub Secretaria de Salud Publica – Division Juridica
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 2013 |
Click here to go to local authority.
China ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/china.png)
National Medicinal Products Administration (NMPA)
Serialization
Data elements | Proprietary Chinese eCode or AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 128 |
Deadline | June 2023 |
Aggregation
Data elements | Proprietary Chinese eCode or AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 128 |
Deadline | June 2023 |
Click here to go to local authority.
Columbia ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/columbia.png)
INVIMA Ministry of Health and Social Protection
Serialization
Data elements | AI(01) – GTIN AI(21) – Serial Number |
Data carrier | RFID |
Deadline | 01 April 2018 |
Click here to go to local authority.
Ecuador ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/ecuador.png)
National Agency for Health Regulatory Control and Surveillance (ARCSA)
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 26 May 2024 |
Click here to go to local authority.
Egypt ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/egypt.png)
Egyptian Ministry of Health
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 31 December 2018 |
Click here to go to local authority.
Europe ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/europe.png)
EU Commission
Directive 2011/62/EU
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(713) – NHRN if applicable AI(21) – Serial Number |
Data carrier | GS1 DataMatrix DataMatrix |
Deadline | 09 February 2019 |
Click here to go to local authority.
India ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/india.png)
Ministry of Health and Family Welfare of India
Serialization
Primary | |
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 Databar |
Deadline | 01 April 2015 |
Secondary | |
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 128 GS1 Databar |
Deadline | 01 October 2013 |
Tertiary | |
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number AI(00) – SSCC |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 01 October 2011 |
Aggregation
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(00) – SSCC |
Data carrier | GS1 128 |
Deadline | 01 July 2019 |
Click here to go to local authority.
Indonesia ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/indonesia.png)
National Agency for Pharmaceuticals and Food Control of the Republic of Indonesia
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2023 |
Click here to go to local authority.
Iran ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/iran.png)
Ministry of Health and Medical Education
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN UID |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2015 |
Click here to go to local authority.
Japan ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/japan.png)
Ministry of Health, Labour and Welfare
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataBar |
Deadline | 01 July 2015 |
Aggregation
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number AI(30) – Quamtity |
Data carrier | GS1 128 |
Deadline | 01 April 2021 |
Click here to go to local authority.
Jordan ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/jordan.png)
Jordanian Food and Drug Administration (JFDA)
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix |
Deadline | 01 July 2018 |
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2020 |
Click here to go to local authority.
Kazachstan ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/kazachstan.png)
Ministry of Finance / Health
Serialization
Data elements | AI(01) – GTIN AI(21) – Serial Number AI(91) – Crypto Key AI(92) – Crypto Code |
Data carrier | GS1 DataMatrix |
Deadline | 01 October 2011 (20%) 01 January 2023 (60%) 01 April 2023 (80%) 01 July 2023 (100%) |
Aggregation
Data elements | AI(00) – SSCC |
Data carrier | GS1 128 |
Deadline | 01 October 2011 (20%) 01 January 2023 (60%) 01 April 2023 (80%) 01 July 2023 (100%) |
Click here to go to local authority.
Lebanon ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/lebanon.png)
Ministry of Public Health
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix |
Deadline | 31 December 2019 |
Click here to go to local authority.
Malaysia ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/malaysia.png)
Malaysian Ministry of Health
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2023 |
Aggregation
Data elements | AI(00) – SSCC |
Data carrier | GS1 128 |
Deadline | 01 January 2023 |
Click here to go to local authority.
Norway ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/norway.png)
The Norwegian Medicines Agency
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 09 February 2019 |
Click here to go to local authority.
Oman ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/oman.png)
Directorate General of Medical Supplies MoH
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix |
Deadline | 31 December 2017 |
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 March 2019 |
Click here to go to local authority.
Pakistan ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/pakistan.png)
Pakistan Drug Regulatory Authority (DRAP)
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix |
Deadline | 01 August 2025 |
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 August 2025 |
Aggregation
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number AI(240) – Product |
Data carrier | GS1 DataMatrix |
Deadline | 15 September 2025 |
Click here to go to local authority.
Philippines ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/philippines.png)
Food and Drug Administration Philippines
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 30 June 2016 |
Click here to go to local authority.
Quatar ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/quatar.png)
Hamad Medical Corporation (HMC)
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 01 January 2018 |
Serialization
Data elements | AI(21) – Serial Number, if applicable |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 01 January 2018 |
Click here to go to local authority.
Russia ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/russia.png)
Ministry of Health of the Russian Federation
Serialization
Data elements | AI(10) – Batch/Lot AI(21) – Serial Number AI(91) – Crypto Key AI(92) – Crypto Code |
Data carrier | GS1 DataMatrix |
Deadline | 01 July 2020 |
Aggregation
Data elements | AI(00) – SSCC or AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 01 July 2020 |
Click here to go to local authority.
Saudi Arabia ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/saudi-arabia.png)
Saudi Food and Drug Administration (SFDA)
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix |
Deadline | 21 March 2015 |
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 12 March 2017 |
Aggregation
Data elements | AI(00) – SSCC |
Data carrier | GS1 128 |
Deadline | 31 March 2020 |
Click here to go to local authority.
South Africa ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/south-africa.png)
Ministry of Health of the Republic of South Africa (NDOH)
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 QR |
Deadline | 01 June 2022 |
Click here to go to local authority.
South Korea ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/south-korea.png)
Ministry for Food and Drug Safety
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 01 January 2013 |
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 128 RFID |
Deadline | 01 January 2016 |
Click here to go to local authority.
Switzerland ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/switzerland.png)
Swiss Federal Office of Public Health (FOPH)
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTINoptional AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 2018 |
Click here to go to local authority.
Tunesia ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/tunesia.png)
Ministry of Public Health
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2019 |
Click here to go to local authority.
Turkey ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/turkey.png)
Republic of Turkey Ministry of Health – Turkish Medicines and Medical Devices Agency (TİTCK)
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 June 2010 |
Aggregation
Data elements | AI(00) – SSCC |
Data carrier | GS1 128 |
Deadline | 01 June 2012 |
Click here to go to local authority.
Ukraine ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/ukraine.png)
State Service of Ukraine on Medicines and Drug Control
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 2021 (not defined) |
Click here to go to local authority.
UAE ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/uae.png)
Department of Health – Abu Dhabi
Batch constant
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2017 |
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix |
Deadline | 01 January 2020 |
Click here to go to local authority.
USA ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/usa.png)
U.S. Food and Drug Administration (FDA)
Serialization
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 27 November 2017 |
Aggregation
Data elements | AI(10) – Batch/Lot AI(17) – Expiration Date AI(01) – GTIN AI(21) – Serial Number |
Data carrier | GS1 DataMatrix GS1 128 |
Deadline | 27 November 2023 |
Click here to go to local authority.
Uzbekistan ![](https://global.laetus.com/wp-content/uploads/dam/web-images/knowledge-base/whitepaper-images/flags/uzbekistan.png)
The State Tax Committee of the Republic of Uzbekistan, the Ministry of Finance and the Ministry of Health
Serialization
Data elements | AI(01) – GTIN AI(21) – Serial Number AI(91) – Crypto Key AI(92) – Crypto Code |
Data carrier | GS1 DataMatrix |
Deadline | 01 September 2022 |
Click here to go to local authority.
Téléchargez notre PDF qui résume les informations et fournit des liens vers les différents règlements.
Veuillez nous fournir les informations suivantes pour télécharger notre aperçu complet des règlements.
Dernière mise à jour : janvier 2023 – toutes les données sont sans garantie.