Life Science Regulations around the world

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.

Drug Supply Chain Security Act (DSCSA)

In the U.S., the Food and 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 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.

 

The Medicines Directive (FMD) of the European Union

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.

Wholesalers and distributors are obligated to guarantee the authenticity of prescription drugs and identify whether or not the outer packaging of medicines has been altered.

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

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.

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;

Serialization For Russian Federal Law No. 425-FZ

The Russian Federal Law No. 425-FZ (decree No 1556) states that in order to track supply chain activity, certain pharmaceutical products must be serialized by January 1, 2020. Unlike the EU’s serialization requirements under FMD, Russian regulations apply to a wider range of pharmaceutical products. These include:

  • Prescription medications
  • Over-the-counter medications
  • 12 Nosologies: Medications for rare diseases that are expensive to treat, such as hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, myeloid leukemia, multiple sclerosis, immunosuppressive therapy for organ transplant patients, Hemolytic-uremic syndrome, juvenile arthritis with systemic onset and Mucopolysaccharidosis type I, II and IV.
  • Free samples

Reporting of serialized products takes place through a centralized database called the Federal State Information System for Monitoring Drug Circulation (FSIS MDC). Manufacturers must onboard with the FSIS MDC and report all serial numbers and batch numbers to the centralized system. Along with the information required by U.S. and European regulations (a GTIN and serial number), the Russian regulations call for a crypto key (4 characters from the GS1 characters set 82) and crypto code (44 characters: Symbols, numbers, lower and upper-case letters from the Latin alphabet).

Each individual unit must be serialized with a 2D barcode that is placed on the box or bottle. This 2D code contains the following information:

  • Global Trade Item Number (GTIN): 14-digit
  • Serial number (SN): 13 symbols of numeric or alphanumeric sequence of the Latin alphabet; can be random
  • Crypto key
  • Crypto code

OTHER LEGISLATIONS AROUND THE WORLD

Download our world regulations map to learn more about the requirements in many more countries

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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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 Europe by reading our white paper:

The Fast Track to Serialization Compliance

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

Find out by reading our flyer.

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