COMPLIANCE CHALLENGE

Falsified and counterfeit 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 the pharmaceutical industry must comply.

Download the world legislation map 2018

Examples of regulations around the world

UNITED STATES

EUROPE

BRAZIL

DRUG SUPPLY CHAIN SECURITY ACT OF THE U.S. FDA

In the U.S., the Federal Drug Administration (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 deadline was postponed to November 2018 to accommodate most of the industry in the United States.

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

 

What are the serialization requirements in the U.S.?

Serialization entails marking packages with a product identifier (GTIN), 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 Serialization Compliance.

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THE FALSIFIED MEDICINES DIRECTIVE (FMD) OF THE EUROPEAN UNION

THE EUROPEAN UNION’S FALSIFIED MEDICINES DIRECTIVE (FMD)

Falsified medicines have always been a major concern for the European Union (EU). To address this concern, the European Commission (EC) has released the Falsified Medicines Directive (EU FMD), which details safety features and procedures designed to protect European patients by ensuring that medicines are safe and of good quality.

The deadline for compliance with the EU FMD is 9 February 2019.

UNDERSTANDING THE EU FMD

Understanding the EU FMD is no easy task, but this impending law will have a significant impact throughout the pharmaceutical and healthcare industries, affecting operations from one end of the supply chain to the other, from manufacturing to dispensing.

Pharmaceutical manufacturersparallel importers and contract manufacturing organisations (CMOs) will have the obligation to guarantee the authenticity of all prescription drugs by identifying individual packs and checking whether the outer packaging of medicines has been tampered with.

European hospitals and retail pharmacies will then be required to decommission prescription medications using unique identifiers before distributing them to patients.

We invite you to contact our EU FMD experts for a better understanding of the new legislation and its implications. In the meantime, here is some of what you need to know, depending on your field:

WHAT DOES THE EU FMD MEAN FOR MANUFACTURERS AND IMPORTERS?

Manufacturers, parallel importers and CMOs in European countries are responsible for supplying unique identifiers for each product lot to their regulatory governing body, the National Medicines Verification Systems (NMVS). Each country’s database is connected to a centralized European data repository, the European Medicines Verification System (EMVS), also known as the European Hub.

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

 

WHAT DOES THE EU FMD MEAN FOR DISPENSERS?

The EU FMD also applies to dispensers, which means any healthcare institution such as hospitals, inpatient or outpatient clinics, or health centres. These institutions will be required to verify and decommission medications before they administer them to patients. In other words, staff will have to authenticate and deactivate medications that were activated by manufacturers as a final step in the tracking process to ensure the product they are providing to the patient is authentic, safe and fit to use.

Learn more about the implications of the EU FMD for dispensers here and discover OPTEL Certa™ Software, our immediate solution to compliance, here.

HOW DOES THE EU FMD WORK?

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

Pharmaceutical manufacturers will be required to upload their prescription medication’s unique identifiers to the European Hub, where they will be activated. The EMVS acts as a “router” to distribute the UIs to the appropriate NMVS. Each country’s NMVS database will contain the UIs of all medications currently active in that given country.

The medication then leaves the manufacturer and moves through the supply chain, including potential distributors, if applicable, before arriving to hospitals and retail pharmacies. Once in the possession of the pharmacy, the medication must be decommissioned, using its unique identifier. The verification process can take place at any point throughout the healthcare supply chain; however, decommissioning must be performed before the medication is administered to the patient.

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

Find out by reading our flyer.

READ

Learn more about the requirements of serialisation 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, Law No. 13.410 of 28 December 2016, together with RDC 157 (Resolução da Diretoria Colegiada, Resolution of the Board of Directors No. 157), lays down that the pharmaceutical industry has until April 2022 to implement traceability in its chain of prescribed drugs. This system must be connected to the central database named the Sistema Nacional de Controle de Medicamentos (National Drug Control System, SNCM), created by the Agência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency, ANVISA), in order to deliver better quality and safety to the final consumer. By means of this procedure, the industry will be able to trace the history and location of each drug, avoid fraud and conduct recalls more accurately and using fewer resources.

The implementation of traceability occurs through the serialization and aggregation of the products. This means that drugs will receive a unique identification printed on the packaging, known as the “Identificador Único de Medicamentos” (“Unique Drugs Identifier”, IUM). The IUM is made up of:

  • Global Trade Item Number, GTIN;
  • ANVISA’s drugs registration code;
  • Serial number;
  • Expiry date;
  • Batch ID;

Once serialized with this information, the products go through the aggregation process which consists of linking one or more IUMs to a transport package, that is, cartons linked to a shipping crate.

Due to the complexity of a project such as this, companies considered time limits of 8-11 months per line, involving the most diverse areas such as engineering, production, IT, maintenance and marketing. As a leader in the traceability market, OPTEL is backed by almost 30 years of experience to help the pharmaceutical industry with this adaptation.