The pharmaceutical regulations across the world play an important role in ensuring the safety and efficacy of the approved drugs. The new serialization regulations being implemented across the globe is expected to further reduce the risk of counterfeit products being sold in the market by strengthening the existing supply chain processes and strict implementation rules.
In this article, we will have a look at a few of the major highlights of 2022 in the pharmaceutical industry related to traceability & serialization and focus on the upcoming regulations.
Major Highlights of 2022
Brazil
Being one of the largest economies in Latin America, Brazil was planning to join Russia, the EU, and many other countries in mandating serialization in its pharma supply chain from April 2022 onwards. However, the regulation got postponed and we are waiting for a clear set of timelines to be published from ANVISA.
Bahrain
The 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.
On 1st May 2022, aggregation became mandatory for any product being sold to Bahrain.
See our blog for more details - https://blog.cosmotrace.com/serialization
UAE
Relating to the latest version of serialization track and trace guidelines by the Ministry of Health and Prevention (MOHAP), the serialization and aggregation reporting to Tatmeen portal will become mandatory from 13th December 2022 onwards. The core objectives are to secure products, safety for patients, and visibility in the supply chain. The new serialization guidelines in UAE were adopted to detect counterfeit and falsified drugs, avoid issues relating to the medicinal treatment, forecast drug scarcities, and ensure precise real-time information among all the stakeholders.
See our blog for more details - https://blog.cosmotrace.com/serialization
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. However, the acquisition of crypto code will differ in case of CRPT Turon as crypto codes only have prepaid option as compared to the pay upon utilization option in case of Russia.
On 2nd April 2022, A resolution was published that describes the introduction of mandatory labeling for 4 product groups which are largely consisting of medicines. Phase wise implementation of Group 1 (Non-orphan medicines) was published.
See our blog for more details - https://blog.cosmotrace.com/serialization
Serialization updates for packs intended for Northern Ireland Markets.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has been the United Kingdom’s (UK) standalone medicines and medical devices regulator since the time the UK started the separation process from the European Union (EU). Inspite of MHRA’s rigorous effort to streamline the process since the past 2 years, there is still a lot of confusion among pharmaceutical companies related to the serialization standard for products supplied in the UK & Northern Ireland (NI). As per the Northern Ireland Protocol for serialization, the packs arriving in Northern Ireland from other parts of the globe (including UK) need to be checked to ensure they comply with EU standards, which has further added to the confusion and uncertainty among the suppliers.
See our blog for more details - https://blog.cosmotrace.com/serialization
Upcoming Serialization Regulations
US DSCSA
The US FDA Drug Supply Chain Security Act (DSCSA) is progressing towards establishing requirements for manufacturers and trading partners to have full interoperable electronic track and trace systems in place by November 2023.
The goal is to improve traceability of drugs by creating a consistent and efficient process for verifying and protecting the legitimacy of drug products at the unit level, as they move throughout the U.S. pharmaceutical supply chain.
See our blog for more details - https://blog.cosmotrace.com/serialization
Kazakhstan
Kazakhstan as the rest of the world, is in the fight against counterfeiting in order to protect the health of its citizens. 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 is planning to establish mandatory labeling and tracking of drugs by 2023 with a phased approach. Kazakhstan’s milestone is to implement 100% of Serialization by 2023.
See our blog for more details - https://blog.cosmotrace.com/serialization
Nigeria
The Federal Government of Nigeria through the Federal Ministry of Health, FMOH established the National Pharmaceutical Traceability Strategy to leverage global standards to establish and implement pharmaceutical traceability in Nigeria. Given the mandate of the National Agency for Food and Drug Administration and Control, NAFDAC, the burden of drug distribution, sale, use and security rests on the Agency. Hence, NAFDAC developed a 5-Year Traceability Implementation plan in line with the national strategy to achieve supply chain visibility and strengthen its pharmacovigilance activities against the scourge of Substandard and Falsified Medicines and Medical Devices. From this strategy document, it is expected that traceability becomes fully operational in the Nigerian Pharmaceutical Supply Chain by the end of the year 2024.
See our blog for more details - https://blog.cosmotrace.com/serialization
Australia
Therapeutic Goods Order (TGO) 106 will go into effect on January 1, 2023 that lays out requirements for medicine packs that a manufacturer may choose to serialize (serialization will continue to be optional) or which include a GS1 Data Matrix code that contains a GTIN.
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 required pharmaceutical serialization requirements.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
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.
