Pharma
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. Here we show you diagrams of the work processes and regulations in the various countries with which our solution complies. You can open each regulation and see a detailed description of all processes.
EU
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
In the European Union, the pharmaceutical industry regulated by FMD adopted in 2011. The primary technical requirement for traceability is applying of unique identifier (UI), which enables verification of the authenticity of individual folding boxes, and becomes mandatory in 2019. Applied codes are uploaded to a central system EMVS, and upon dispensing a verification is done. Risk-based verifications by wholesale distributors in between are possible. If a verification identifies an issue, such as identical numbers or a package being dispensed multiple times, or if a number is not found in the database, an alert is triggered immediately. The Marketing Authorization Holder is responsible for processing such alerts. From February 2024, all pharmacies and hospitals in the EU must verify the authenticity of the unique identifier on prescription medicines before dispensing them to patients. Strict regulations, highest standarts, various reports and verifications make implemention of serialization for pharma is quite chalenging.
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
Bahrain
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
The Kingdom of Bahrain's track and trace regulation closely follows the standards of other countries and is based on GS1 standards. Traceability for pharmaceutical products was first initiated in 2017 by Legislative Decree No. 41. Following the implementation of mandatory serialization for MAH/CMO invoicing, companies are required to report all traceability events (commissioning, shipment/receiving, dispensing) to the NHRA-MVC Traceability Hub. A digital signature is required for all messages, and third-party entities such as 3PLs are not permitted to report on behalf of MAHs. After the implementation of mandatory serialization for MAH/CMO invoicing, companies start reporting all traceability events to the NHRA-MVC Traceability Hub. Aggregation reporting becomes mandatory in the last phase of the project. The pharmaceutical industry is highly regulated, and the comprehensive labelling system adds one more layer of complexity.
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
Brazil
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
T&T LEGISLATION IN BRAZIL (IS CURRENTLY ON HOLD).
The first drafts of legal acts obligating the serialization of pharmaceutical products appeared in Brazil in 2019. The Serialized Drug Traceability Program captures activities from the manufacturing or import of drugs through the distribution of the drugs in the downstream supply chain until they reach the point of dispensing or supply to establishments authorized by the Brazilian Health Regulatory Agency (ANVISA), such as medical institutes and research labs. To achieve serialized drug traceability, a national-level reporting system called SNCM has been formed. All actors must possess authorization or a license to carry out their respective activity and have a valid digital certificate for the CNPJ registered with ANVISA. The digital certificate is used to authenticate communications made with the SNCM.
Only physical transactions of goods must be reported to SNCM. The registration holder must report all applicable distributors in their distribution chain implementation plan for SNCM. The members of the distribution chain are responsible for indicating expedition/reception events and information about carriers. It is also possible to delegate data exchange with SNCM to third parties referred to as "attorneys". Choosing the right partner for implementation of traceability solution will be the key to complying with strict regulations and building effective data exchange with your business partners.
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
Kazakhstan
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
The pharmaceutical market in the Republic of Kazakhstan is experiencing significant growth year after year, with over 30 local manufacturers providing 15% of all medical products in the market. Serialization in Kazakhstan is a part of Eurasian Economic Union (EAEU) international project and the regulation of all its members is quite similar and complex especially for pharmaceutical products. In the first phase of implementation, 92 pharmaceutical products will be required to undergo serialization starting from July 1st, 2022. This means that the products will be marked with unique serial numbers and crypto codes, and a Utilization report must be submitted to the Kazakhstan OMS System. Subsequent phases will expand the list of products subject to serialization, and will require reporting of traceability events and aggregation to the IS MPT system. The specific scope and milestones for these phases will be specified by the market regulator. Due to the continuously evolving regulatory landscape, long-term planning in this market can be challenging.
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
Russia
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
Russia has implemented a comprehensive labelling system for pharmaceutical products in order to enhance traceability and prevent counterfeiting.
Announced in 2018, serialization and tracebility in the first phase became mandatory for a list of products for high-cost nosologies. In 2020, the system expanded to include the tracking of the movement of all pharmaceuticals across the supply chain. All pharmaceutical products to be labelled with a unique identification code, which must be registered with the government's central database MDLP which is separate from national traceability Chestniy Znak system. The system requires from supply chain participants to generate a large number of different reports, providing full tracebility, control over batches and expiry dates. The pharmaceutical regulation is one of the most complicated when compared with other industries due to its highly regulated nature and stringent quality control requirements. The labelling system adds one more layer of complexity.
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
Saudi Arabia
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
The track and trace regulation of the Kindom of Saudi Arabia closely follows the standards of other countries and is based on GS1 standards. All products must be labeled in compliance with regulatory rules. Stakeholders began reporting SNs (serial numbers) through the new authority platform called DTTS (Drug Track and Trace System) from January 7th, 2019. External manufacturers (overseeing suppliers with production outside of KSA) have the option to provide their agents with a flat list of SNs, enabling them to upload the list directly into the DTTS. Aggregation reporting became mandatory from August 2020. The main reporting events for stakeholders include commissioning/decommissioning, shipment/receive, sale/buy/dispense, and aggregation. Depending on the type of business, import/export operations, product deactivation, return, and transfer must also be reported. The pharmaceutical industry is highly regulated, and the comprehensive labelling system adds one more layer of complexity.
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
UAE
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
The traceability decree that applies to all conventional medicines was announced in the UAE in June 2021. After an 18-month transitional period intended for serialization implementation, all operations involving serialized drugs must be reported to the Tatmeen traceability system by code owners. Distributors, dispensing facilities, and medical centers are responsible for reporting appropriate shipping events related to drugs. MAHs must also provide a reference to the Shipping Import Permit in a single message when commissioning codes.
In a special scenario, a business partner may delegate technical activities to a third party by sharing credentials and instructions. In such cases, credentials are used in association with the business partner's Global Location Identifier (GLN). The pharmaceutical industry is highly regulated, and the comprehensive labelling system adds one more layer of complexity.
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
USA
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
To achieve traceability of certain prescription drugs, the Drug Supply Chain Security Act (DSCSA) was signed on November 27, 2013, superseding various state regulations. Each prescription drug product must have a unique product identifier encoded in a 2D barcode that contains the product's National Drug Code (NDC), serial number, lot number, expiration date, and can be used to track and trace the product throughout the supply chain. No national repository for reporting and storing serialization data is provided for the US market. Manufacturers, wholesale distributors, repackagers, and dispensers must keep a record of the transaction history for each prescription drug product, including the product's unique identifier, transaction information, and the information about the previous and next owner of the product.
Wholesale distributors and dispensers must verify the authenticity of the prescription drug before dispensing it to the patient, and all stakeholders in the supply chain must investigate and report any suspected products. Saleable returns are verified by wholesalers.
Serialization information is exchanged at a lot level starting from Nov 2015 and serialization indicators must be printed on prescription drugs from Nov 2017.
On November 27, 2023 manufacturers start to provide full aggregation to downstream partners.
Choosing and implementing the right traceability solution will be the key to complying with strict regulations and building effective data exchange with your business partners.
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
Uzbekistan
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
Traceability of goods in Uzbekistan is a part of Eurasian Economic Union (EAEU) international project and the regulation of all its members is quite similar and complex especially for pharmaceutical products. The serialization is mandated, requiring the products to be marked with unique serial numbers and crypto codes by September 2022. By March 2023, all product and their aggregation hierrarchy must be traced throughout the supply chain. The updated regulations that are being introduced gradually make long-term planning on this market quite challenging.
Сodes are issued by regulatory system on a paid basis upon issuance. It is also possible to request only the cryptographic part of the code from the regulatory system, while generating serial numbers independently. No code application report is needed, all codes taken from the registry are considered to be applied. Several methods for withdrawing codes from circulation (for samples and rejects) exist. Starting from 1 June 2023 it is mandatory to form and include an aggregated import code (AIC) into the customs declaration. There is no separate "circulation entry" process; codes are entered into circulation either upon shipment (in case of local production) or customs clearance (if imported).
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