The pharmaceutical regulations across the world play an important role in ensuring the safety and efficacy of the approved drugs. However, with new serialization regulations coming into picture for various countries across the globe, it is expected to increase the challenges & complexities of managing the serialization projects for the pharmaceutical companies.
In this article, we will have a look at a few of the defined regulations where countries have laid out the rules for implementing full track and trace system. However, there are also a few countries that are planning to implement full traceability in coming years, and it would be important to keep a close eye on them as we move along, details about those countries will be seen in the Undefined regulations section of this article.
Defined Regulations
BAHRAIN
The NHRA (National Health Regulatory Authority) in Bahrain plays a key role in ensuring expected health standards are met. This guarantees that patients are provided with safe drugs and can access the best form of medical care. The NHRA is an independent sector that regulates the entire healthcare system in the Kingdom. It has effective regulatory procedures that involve the licensing of all parties involved in the healthcare business such as pharmaceutical centers and hospitals. The NHRA has implemented a blockchain based end to end traceability hub which is the first of its kind in the GCC.
- Key Upcoming Dates -
- 1st May 2022 - Aggregation deadline for the MAH
- 1st June 2022 - Deadline for the Agents, Distributors, Pharmacies, Dispensers to scan for shipments and medicines authentication
- 1st May 2022 - Aggregation deadline for the MAH
- Traceability Requirements - Serialization & Aggregation required
- Summary of Current Situation – Serialization was mandated in Phase 1 that ended in December 2021. Aggregation deadline for the MAH is 1st May 2022, followed by deadline for the Agents, Distributors, Pharmacies, Dispensers to scan for shipments and medicines authentication starting from 1st June 2022.
- Coding Requirements – GTIN, Lot/batch number, Serial Number & Expiry Date
BRAZIL
Being one of the largest economies in Latin America, Brazil will join Russia, the EU, and many other countries for mandating serialization in its pharma supply chain. Brazil’s legislation has a complex set of requirements for putting into effect their serialization and reporting processes in order to achieve traceability. Back in 2016, ANVISA signed the National Medicine Control System (SNCM) into law (Law No. 13.410) and established the serialization requirements and timelines over the period of time for the entire Brazil pharmaceutical supply chain
- Key Upcoming Dates -
- 28th April 2022 - Deadline for implementation of serialization for all products and reporting to the national drug control system
- 28th April 2022 - Deadline for implementation of serialization for all products and reporting to the national drug control system
- Traceability Requirements - Serialization & Aggregation required
- Summary of Current Situation – Sistema Nacional de Controle de Medicamentos(SNCM) is originally planned for 28th April 2022. However, proposal has been presented to the Chamber of Deputies to postpone the implementation of the regulation by 3 years.
- Coding Requirements – GTIN, Lot/batch number, Anvisa registration number, Serial Number & Expiry Date
UAE
The UAE delegates the validation of serialization regulations through Tatmeen which is a digital platform for the ministry. Tatmeen is a Next-Generation Track-and-Trace, fully automated paperless drug and medical supplies management system for the UAE Healthcare sector, launched by the Ministry of Health and Prevention (MOHAP) to develop a centralized platform. Tatmeen will be integrated with Salam, which is the (Dubai Health Authority) DHA’s electronic medical record system that provides an electronic catalogue and the availability of medical items. This integration will provide a more comprehensive traceability system.
- Key Upcoming Dates -
- 13th December 2022 - Deadline for implementing the 2D Barcode & Serialization requirements and reporting this to Tatmeen
- Traceability Requirements - Serialization & Aggregation required
- Summary of Current Situation – UAE has started implementing the 2D Barcode & Serialization requirements on the pack since December’21 but the deadline for reporting this information to Tatmeen is 13th December 2022.
- Coding Requirements – GTIN, Lot/batch number, Serial Number & Expiry Date
KAZAKHSTAN
The problem of tracking counterfeit drugs in former Soviet republics has become tedious with the former unorganized approach. Kazakhstan faces issues of having a high number of counterfeit drugs, demand for generics, drug shortages and increased online buying have further fueled the sale of counterfeit drugs. To overcome this, the government of Kazakhstan has planned to start a phase wise serialization implementation.
- Key Upcoming Dates -
- Phase 1 “working” deadline (93 products): July 2022
- Phase 2 “working” deadline (20% of products): October 2022
- January 2023 – The estimated start of mandatory data reporting with serialization and the same product scope.
- April 1, 2023: Mandatory serialization of at least 80% of all drugs
- July 1, 2023: Serialization of 100% of medicines
- Traceability Requirements - Serialization & Aggregation required
- Summary of Current Situation – The phase wise implementation was expected to start from May 2022. However, further decisions are pending on the request which was sent from the Association of International Pharmaceutical Manufacturers (AIPM) in Kazakhstan to the Prime Minister to revoke the current timeline for mandatory labeling and to review implementation milestones with Industry:
- Coding Requirements for barcode – GTIN, Serial Number, Crypto key & Crypto code
- Coding Requirements for Human Readable – GTIN, Lot/batch number, Serial Number & Expiry Date
Uzbekistan
CRPT Turon is managing the Track & Trace system for Uzbekistan with the objective of guaranteeing consumers the authenticity and declared quality of the purchased products which are being imported or produced in the territory of the Republic of Uzbekistan. The traceability system developed by CRPT Turon is called ASL BELGISI.
CRPT Turon is very similar to the Russian Track & Trace system which is managed by Russia’s Center for Research in Perspective Technologies (CRPT). Like the Russian model, consumers in Uzbekistan can also download the mobile app to scan the products and for reporting the suspected products and their feedback about the system.
- Key Upcoming Dates -
- September 1, 2022 - Labeling deadline for Group 1
- September 1, 2022 - Labeling deadline for Group 1
- Traceability Requirements - Serialization & Aggregation required
- Summary of Current Situation – The phase wise implementation was expected to start from Feb 2022. However, the industry associations asked for the delay in requirement. The recent Decree that was signed into law on April 2, 2022, defines mandatory labeling for four groups of medicines and medical products. A detailed five-phase plan was laid out in the decree, including contractual and administrative tasks to be completed ahead of the labeling deadline for a given group. The labeling deadline for Group 1 is September 1, 2022.
- Coding Requirements for barcode – GTIN, Serial Number, Crypto key & Crypto code
- Coding Requirements for Human Readable – GTIN, Lot/batch number, Serial Number & Expiry Date
US
The US DSCSA was enacted on Nov 2013 and since then we have seen phased approach from the US FDA to implement the requirements. The upcoming deadline of November 2023 requires the partner to exchange all TI (Transaction Information), TH (Transaction History) and TS (Transaction Statement) in a secure, interoperable, and electronic manner. The TI must include the unique product identifier at the package level for all the packages included in the transaction. Also, a system needs to be in place to support the request for verification or investigation of suspects or illegitimate products.
- Key Upcoming Dates -
- November 2023 - Full unit level traceability and verification of saleable returns.
- November 2023 - Full unit level traceability and verification of saleable returns.
- Traceability Requirements - Serialization & Aggregation required
- Summary of Current Situation – Manufacturers and trading partners to have full interoperable electronic unit-level traceability systems in place by November 2023– The partners should be able to exchange transaction data including unit-level serial numbers in a secure, interoperable, and electronic manner.
Verification of saleable returns – Manufacturers, wholesalers & repackagers must be able to verify saleable returns by November 2023.
- Coding Requirements– GTIN, Lot/batch number, Serial Number & Expiry Date
Undefined Regulations:
Africa
October 10, 2021 – A public consultation on serialization and barcoding requirements for medicines was launched by The Zambia Medicines Regulatory Authority (ZAMRA). More details awaited here.
Botswana
The Botswana Medicines Regulatory Authority (BOMRA) plans on defining the coding standards and master data architecture by the end of 2023.
Columbia
GS1 is working closely with the manufacturers & the wholesalers in the country to create standards for implementation of track and trace requirements there.
Ecuador
February 1, 2022 – Ecuadorian government published Article 79 of Decree 337 describing high-level requirements for medicines traceability when supplied to the RPIS (Public Health Network). More details awaited here.
Ethiopia
The Ethiopia Food and Drug Administration (EFDA) is working on an online platform to collect the product master data from the MAHs. Currently they are using excel/spreadsheet from the MAHs to gather this information.
Indonesia
The National Agency of Drug and Food Control (BPOM) is planning to establish a first deadline of December 2022 for pharmaceutical medicines traceability. More details awaited here.
Japan
April 18, 2021 - Japan’s Pharmaceutical and Medical Devices Act (PMDA) have set the deadline of December 2022 for obligatory barcoding of drugs and medical devices. More details awaited here.
Kyrgyz Republic
March 27, 2022 - A pilot project for labeling of beer, bottled water, soft drinks, tobacco, and nicotine products was launched by The State Tax Service and the Cabinet of Ministers. Medicines are not currently in scope, however more details are awaited here.
Lebanon
The Lebanese Ministry of Public Health (MoPH) has organized a traceability committee to work on the traceability requirements. Deadlines of full implementations are not yet published. More details awaited here.
Malaysia
The Malaysian government has planned to implement track and trace requirements from 2023. More details awaited here.
Pakistan
The industry is discussing with the authorities to have a full track and trace system in place by 2025.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the serialization project to meet the deadlines.
As Serialization Consulting & Implementation Experts, our focus is on delivering the absolute best serialization support by offering long-term serialization and sustainability strategies and providing forward-thinking industry solutions.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, partners and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions.
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