Farmacéutica
The pharmaceutical industry with its highest standards and GxP (Good Practices) validations faces a range of challenging demands due to the high-speed production lines, variety of consumer packages, contract manufacturing, and specific integrations between manufacturers, suppliers, and logistics providers. Traceability regulations establish full control over each individual package in the context of its batch and expiry date.
Aquí le mostramos diagramas de los procesos de trabajo y regulaciones en los distintos países con los que cumple nuestra solución. Puede abrir cada reglamento y ver una descripción detallada de todos los procesos.
UE
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
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Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
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Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
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Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
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Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
En la Unión Europea, la industria farmacéutica adoptó la regulación del FMD en el 2021. El principal requisito técnico para la trazabilidad es la aplicación del identificador único (UI), que permite la verificación de la autenticidad de las cajas plegables individuales siendo obligatorio en el 2019. Los códigos aplicados se cargan en un sistema central EMVS, y al dispensar se realiza una verificación. Son posibles las verificaciones basadas en el riesgo por parte de los distribuidores mayoristas intermedios . Si una verificación identifica un problema como números idénticos o un paquete que se dispensa varias veces o si no se encuentra un número en la base de datos, se activa una alerta inmediatamente. El Titular de la autorización de comercialización es responsable de procesar dichas alertas. A partir de febrero de 2024, todas las farmacias y hospitales de la UE deben verificar la autenticidad del identificador único de los medicamentos sujetos a prescripción antes de dispensarlos a los pacientes. Las regulaciones estrictas, los más altos estándares, varios informes y verificaciones hacen que la implementación de la serialización para la industria farmacéutica sea bastante desafiante.
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management
Bahrein
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
|
||||||||||||
Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
||||||||||
Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
||||||||||
Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
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Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
La regulación de seguimiento y localización del Reino de Bahrein sigue de cerca las normas de otros países y se basa en las normas GS1. La trazabilidad de los productos farmacéuticos se inició por primera vez en 2017 mediante el Decreto Legislativo No. 41. Tras la implementación de la serialización obligatoria para la facturación de MAH/CMO, las empresas deben informar todos los eventos de trazabilidad (puesta en marcha, envío/recepción, dispensación) al Centro de Trazabilidad NHRA-MVC. Se requiere una firma digital para todos los mensajes, y las entidades de terceros, como los 3PL, no pueden informar en nombre de los MAH. Después de la implementación de la serialización obligatoria para la facturación de MAH/CMO, las empresas comienzan a informar todos los eventos de trazabilidad al Centro de Trazabilidad NHRA-MVC. Los informes de agregación se vuelven obligatorios en la última fase del proyecto. La industria farmacéutica está altamente regulada, y el sistema de etiquetado integral agrega una capa más de complejidad.
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management
Brasil
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
|
||||||||||||
Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
||||||||||
Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
||||||||||
Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
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Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
LEGISLACIÓN T&T EN BRASIL (ACTUALMENTE ESTÁ EN ESPERA)
Los primeros borradores de actos jurídicos que obligan a la serialización de productos farmacéuticos aparecieron en Brasil en 2019. El Programa de Trazabilidad Serializada de Medicamentos captura actividades desde la fabricación o importación de medicamentos hasta la distribución de los medicamentos en la cadena de suministro posterior hasta que llegan al punto de dispensación o suministro a establecimientos autorizados por la Agencia Brasileña de Regulación Sanitaria (ANVISA), como institutos médicos y laboratorios de investigación. Para lograr la trazabilidad serializada de los medicamentos, se ha formado un sistema de notificación a nivel nacional llamado SNCM. Todos los actores deben poseer una autorización o una licencia para llevar a cabo su respectiva actividad y tener un certificado digital válido para el CNPJ registrado en ANVISA. El certificado digital se utiliza para autenticar las comunicaciones realizadas con la SNCM.
Sólo las transacciones físicas de bienes deben ser reportadas a la SNCM. El titular del registro debe informar a todos los distribuidores aplicables en su plan de implementación de la cadena de distribución para la SNCM. Los miembros de la cadena de distribución son responsables de indicar los eventos de expedición/recepción e información sobre los transportistas. También es posible delegar el intercambio de datos con la SNCM a terceros denominados "abogados". Elegir el socio adecuado para la implementación de la solución de trazabilidad será la clave para cumplir con las estrictas regulaciones y crear un intercambio de datos efectivo con sus socios comerciales.
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management
Kazajstán
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
|
||||||||||||
Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
||||||||||
Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
||||||||||
Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
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Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
El mercado farmacéutico en la República de Kazajstán está experimentando un crecimiento significativo año tras año, con más de 30 fabricantes locales que proporcionan el 15% de todos los productos médicos en el mercado. La serialización en Kazajstán es parte del proyecto internacional de la Unión Económica Euroasiática (EAEU) y la regulación de todos sus miembros es bastante similar y compleja, especialmente para los productos farmacéuticos. En la primera fase de implementación, se requerirá que 92 productos farmacéuticos se sometan a serialización a partir del 1 de julio de 2022. Esto significa que los productos se marcarán con números de serie únicos y códigos criptográficos, y se debe enviar un informe de utilización al sistema OMS de Kazajstán. Las fases posteriores ampliarán la lista de productos sujetos a serialización y requerirán la notificación de eventos de trazabilidad y la agregación al sistema IS MPT. El alcance específico y los hitos para estas fases serán especificados por el regulador del mercado. Debido al panorama regulatorio en constante evolución, la planificación a largo plazo en este mercado puede ser un desafío.
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management
Rusia
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
|
||||||||||||
Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
||||||||||
Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
||||||||||
Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
||||||||||
Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
Rusia ha aplicado un sistema integral de etiquetado de los productos farmacéuticos con el fin de mejorar la trazabilidad y prevenir la falsificación.
Anunciado en 2018, la serialización y la trazabilidad en la primera fase se convirtieron en obligatorias para una lista de productos para nosologías de alto costo. En 2020, el sistema se expandió para incluir el seguimiento del movimiento de todos los productos farmacéuticos a través de la cadena de suministro. Todos los productos farmacéuticos deben etiquetarse con un código de identificación único, que debe registrarse en la base de datos central del gobierno MDLP, que está separada del sistema nacional de trazabilidad Chestniy Znak. El sistema requiere que los participantes de la cadena de suministro generen una gran cantidad de informes diferentes, proporcionando trazabilidad completa, control sobre lotes y fechas de vencimiento. La regulación farmacéutica es una de las más complicadas en comparación con otras industrias debido a su naturaleza altamente regulada y estrictos requisitos de control de calidad. El sistema de etiquetado añade una capa más de complejidad.
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management
Arabia Saudí
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
|
||||||||||||
Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
||||||||||
Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
||||||||||
Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
||||||||||
Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
La regulación de seguimiento y localización del Reino de Arabia Saudita sigue de cerca los estándares de otros países y se basa en los estándares GS1. Todos los productos deben estar etiquetados de conformidad con las normas reglamentarias. Las partes interesadas comenzaron a informar SN (números de serie) a través de la nueva plataforma de autoridad llamada DTTS (Drug Track and Trace System) a partir del 7 de enero de 2019. Los fabricantes externos (que supervisan a los proveedores con producción fuera de KSA) tienen la opción de proporcionar a sus agentes una lista plana de SN, lo que les permite cargar la lista directamente en el TDTS. Los informes de agregación pasaron a ser obligatorios a partir de agosto de 2020. Los principales eventos de informes para las partes interesadas incluyen la puesta en marcha / desmantelamiento, envío / recepción, venta / compra / dispensación y agregación. Dependiendo del tipo de negocio, también se deben informar las operaciones de importación / exportación, desactivación, devolución y transferencia del producto. La industria farmacéutica está altamente regulada, y el sistema de etiquetado integral agrega una capa más de complejidad.
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management
EAU
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
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Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
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Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
||||||||||
Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
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Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
El decreto de trazabilidad que se aplica a todos los medicamentos convencionales se anunció en los Emiratos Árabes Unidos en junio de 2021. Después de un período de transición de 18 meses destinado a la implementación de la serialización, todas las operaciones que involucran medicamentos serializados deben ser reportadas al sistema de trazabilidad de Tatmeen por los propietarios del código. Los distribuidores, las instalaciones de dispensación y los centros médicos son responsables de informar sobre cualquier eventualidad relacionada con el envío de los medicamentos. Los MAH también deben proporcionar una referencia al permiso de importación de envío en un solo mensaje al elaborar los códigos.
En un escenario especial, un socio comercial puede delegar actividades técnicas a un tercero compartiendo credenciales e instrucciones. En tales casos, las credenciales se utilizan en asociación con el identificador de ubicación global (GLN) del socio comercial. La industria farmacéutica está altamente regulada, y el sistema de etiquetado integral agrega una capa más de complejidad.
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management
UU.
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
|
||||||||||||
Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
||||||||||
Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
||||||||||
Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
||||||||||
Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
Para lograr la trazabilidad de ciertos medicamentos recetados, el 27 de noviembre de 2013 se firmó la Ley de Seguridad de la Cadena de Suministro de Medicamentos (DSCSA), reemplazando varias regulaciones estatales. Cada producto de medicamentos recetados debe tener un identificador de producto único codificado en un código de barras 2D que contenga el Código Nacional de Medicamentos (NDC) del producto, el número de serie, el número de lote, la fecha de vencimiento y se puede usar para rastrear el producto a lo largo de la cadena de suministro. No se proporciona ningún repositorio nacional para informar y almacenar datos de serialización para el mercado estadounidense. Los fabricantes, distribuidores mayoristas, reenvasadores y dispensadores deben mantener un registro del historial de transacciones para cada producto de medicamentos recetados, incluido el identificador único del producto, la información de la transacción y la información sobre el propietario anterior y siguiente del producto. Los distribuidores y dispensadores mayoristas deben verificar la autenticidad del medicamento recetado antes de dispensarlo al paciente y todas las partes interesadas en la cadena de suministro deben investigar e informar cualquier producto sospechoso. Las devoluciones vendibles son verificadas por mayoristas.
La información de serialización se intercambia a nivel de lote a partir de noviembre de 2015 y los indicadores de serialización deben imprimirse en medicamentos recetados a partir de noviembre de 2017.
El 27 de noviembre de 2023, los fabricantes comienzan a proporcionar una agregación completa de los socios posteriores.
Elegir e implementar la solución de trazabilidad adecuada será la clave para cumplir con las estrictas regulaciones y crear un intercambio de datos efectivo con sus socios comerciales.
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management
Uzbekistán
Choose your role to see how you can benefit from our solution
MANUFACTURER
| As a manufacturer, your company has to request unique identifiers (UIs), receive them, and apply them individually to every product you produce. This is called serialization. Kvinta requests, provides, and stores these unique identifiers and communicates with the respective regulator. All UIs can be aggregated and disaggregated according to the different packaging levels applicable to your industry. Kvinta also serves your need for transparent reporting functionalities and analytics to gain additional benefits. |
|
||||||||||||
Standard processes
- Manufacture products
- Package and label product units
- Pack product units into pack hierarchies for logistical handling
- Ship to finished goods to market
Serialization and T&T processes
- Generating/ordering/receiving unique identification numbers
- Serialization of goods at the item level and record applied codes
- Serialization at the packaging level
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to authorities
- Data exchange with supply chain partners via interfaces
- Unique identification numbers management
DISTRIBUTOR/3PL
| To be able to track and trace your products, your company needs to detect all inbound/outbound activities in your internal supply chain by scanning products. Aggregated and disaggregated data will be automatically submitted into the respective data cloud by Kvinta. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. Kvinta’s comprehensive reporting functionalities will ensure your company’s transparency regarding the compliant flow of products through the supply chain. |
|
||||||||||
Standard processes
- Receive goods
- Repackage goods for distribution
- Ship to finished goods to market
Serialization and T&T processes
- Outbound/inbound scanning
- Recording aggregation/disaggregation activities at different packaging levels
- Reporting the serialization data to Authorities (if required)
- Data exchange with manufacturers or other partners via interfaces
- Return/Damage/Sample management
DISPENSER/RETAILER
| The Track & Trace processes include the point of sales as the last point of tracking. Your company can use Kvinta to take advantage of the seamless and fast flow of information concerning the last point of the secured supply chain. In the unlikely event of product returns from the market, Kvinta will also manage the respective data flow. |
|
||||||||||
Standard processes
- Receive goods
- Sell goods to consumer/patient
Serialization and T&T processes
- Inbound scanning
- Reporting the serialization data to Authorities
- Data exchange with supply chain partners via interfaces
- Recording aggregation/disaggregation activities at different packaging levels
- Return/Damage/Sample management
CONSUMER
| One of the main stakeholders in the whole process of traceability is the consumer. T&T enables consumers to authenticate the product, get service support, and precise product information to make a conscious decision. Traceability brings transparency, a precious benefit in the modern world of conscious consumption. This last mile of T&T generates long-term benefits for companies that invest in sustainable business practices, support environmental initiatives, and build a reliable customer base. Kvinta, as an enterprise-level software solution, orchestrates the data and connects unique serial numbers to the marketing\service information for consumers making the serial number a service getaway. |
|
||||||||||
Standard processes
- Purchase of goods
- Return of goods
- Service request
Serialization and T&T processes
- Authentification
- Product information request
- Service request
- Recycle request
La trazabilidad de los productos en Uzbekistán es parte del proyecto internacional de la Unión Económica Euroasiática (EAEU) y la regulación de todos sus miembros es bastante similar y compleja, especialmente para los productos farmacéuticos. La serialización es obligatoria lo que requiere que los productos estén marcados con números de serie únicos y códigos criptográficos para septiembre de 2022. Para marzo de 2023, todos los productos y su jerarquía de agregación deben rastrearse a lo largo de la cadena de suministro. Las regulaciones actualizadas que se están introduciendo gradualmente hacen que la planificación a largo plazo en este mercado sea bastante desafiante. Los Сodigos son emitidos por el sistema regulatorio contra pago en el momento de la emisión. También es posible solicitar solo la parte criptográfica del código del sistema regulatorio, mientras se generan números de serie de forma independiente. No se necesita ningún informe de aplicación de código, todos los códigos tomados del registro se consideran aplicados. Existen varios métodos para retirar códigos de la circulación (para muestras y rechazos). A partir del 1 de junio de 2023, es obligatorio formar e incluir un código de importación agregado (AIC) en la declaración de aduanas. No existe un proceso separado de "entrada de circulación"; Los códigos se ponen en circulación en el momento del envío (en caso de producción local) o del despacho de aduana (si se importan).
Market specific features
Benefits
The ability to connect an unlimited number of partners from different countries within the same KVINTA platform.
KVINTA is able to process a large number of messages on produced and shipped goods
Allows you to work with data both in manual and automatic mode. Which can be applicable to production, print shops, and 3PL's.
KVINTA is an independent SaaS-solution that does not erload the company ERP system. If you have third-party partners, a system independent of the corporate ERP is needed. (In terms of data security).
24/7 availability
Supported global standards
Fully featured repository
Release Management