COMPLIANCE CHALLENGE

Falsified and counterfeited drugs and medicines are a real risk to customers’ health. As falsified medicines become more sophisticated, the risk of them reaching patients increases. They represent a serious threat to global health and call for a comprehensive strategy at both national and international levels.
For that reason, government authorities all around the world are defining and implementing regulations with which pharmaceutical industry players must comply.

Examples of regulations around the world

UNITED STATES

EUROPE

BRAZIL

DRUG SUPPLY CHAIN SECURITY ACT OF THE FDA IN THE US

In the US, the FDA has defined standards to secure the drug supply chain – standardized numerical identification for prescription drug packages is now required.

This is serialization.

Serialization should have been applied and mandatory in November 2017 further to the Drug Supply Chain Security Act

(DSCSA), but the official date was postponed to November 2018, to accommodate most of the industry in the United States.

Manufacturers producing in the US or exporting toward this market must comply with the local regulations.

 

What are the serialization requirements in the US?

Serialization entails marking packages with a product identifier (GITIN), a unique serial number, a lot number and an expiration date. The serialization must be done to the smallest packaging level of a product, should it be a box, a vial or a bottle and all data must be included in a 2D Data Matrix (GS1) data carrier.

Learn more about the serialization requirements by reading the HCP Serialization Playbook.

Aggregation is the next logical step and requirement of the DSCSA. All companies that have just finished implementing the serialization process are expected to implement this next critical step by 2023.

 

What is aggregation?

Aggregation is the association of uniquely serialized items to higher packaging levels, which also have a unique serial number. The serialized items inside a container are regarded as the “children,” and the serialized container containing these packs is called the “parent.” In a bundle of bottles or cartons, each unit has its own serial number, but the bundle itself has a top label including a unique serial number. In this case, the bottles or cartons are the children, and the bundle itself is the parent.

In short, aggregation is the process of creating a hierarchical relationship between unique identifiers assigned to packaging containers.

Learn more about the requirements of Aggregation by reading our white paper:

Requirements and Challenges of Aggregation in the United States

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Learn more about the requirements of serialization in the United States by reading our white paper:

The Fast Track to Serialisation compliance.

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THE FALSIFIED MEDICINES DIRECTIVE (FMD) OF THE EUROPEAN UNION

Falsified medicines have always been a major concern for the European Union (EU) as they represent a serious threat to public health and safety. To address this concern, the European Commission (EC) has released the Falsified Medicines Directive (FMD), which details the safety features designed to protect European patients and ensure that medicines are safe and of good quality. The delegated regulation will apply as of February 9, 2019.

Manufacturers, wholesalers and contract manufacturing organizations (CMOs) will soon have the obligation to guarantee the authenticity of any prescription drugs by identifying individual packs and checking whether the outer packaging of medicines has been tampered with.

 

What are the European serialization requirements?

Manufacturers, wholesalers and CMOs are responsible for supplying unique identifiers for each product lot to their regulatory government institution/ministry of health. Each country’s database is connected to a centralized European data repository.

Manufacturers must mark packages with a 2D Data Matrix (GS1) encoded with GITIN or NTIN, serial number, lot number, expiration date and national reimbursement identification if it is required by an individual country. A tamper-evidence feature is also required on the packaging.

 

How does it work?

To implement the EU FMD, data will be exchanged between the European Medication Verification System (EMVS), also known as the European Hub, and the National Medication Verification Systems (NMVS), developed by each individual country within the

European Union. The EMVS will receive a Unique Identifier (UI) number from the manufacturer for each prescription medicine to be sold in Europe and act as a “router” to distribute them to the proper NMVS.

Each country’s NMVS database will contain the UIs of all medication currently active in that given country.

What does FMD compliance mean for European pharma wholesalers and distributors?

Find out by reading our flyer

READ

Learn more about the requirements of serialization in Europe by reading our white paper:

The Fast Track to Serialisation compliance.

DOWNLOAD

THE NATIONAL AGENCY OF SANITARY SURVEILLANCE IN BRAZIL (ANVISA)

In Brazil, the pharmaceutical industry has until April 2022 to implement a traceability solution for its prescribed medications. This system should be connected to the central database called the ‘Sistema Nacional de Controle de Medicamentos‘ (SNCM), created by the National Agency of Sanitary Surveillance (ANVISA), to bring more quality and safety to the consumer. Through this procedure, the industry will be able to trace the history and location of each drug, avoid fraud and conduct recalls more accurately with fewer resources.

Traceability is implemented through the serialization and aggregation of products. This means that drugs will receive a unique identification printed on the packaging, called an IUM. The IUM consists of:

  • GTIN
  • Drug registration code according to ANVISA
  • Serial number
  • Expiration date
  • Batch identification

Once serialized with this information, the products go through the aggregation process, which consists of linking one or more IUMs to a bigger package, such as cartons attached to a shipping box.

As a global leader in Track&Trace solutions, OPTEL has nearly 30 years of experience helping the pharmaceutical industry through this process.