Compliance with European Union Falsified Medicines Directive (EU FMD)

Compliance with European Union Falsified Medicines Directive (EU FMD)

The Organization for Economic Cooperation and Development (OECD) draws attention to the spread of counterfeit pharmaceuticals with its study. Emphasizing that access to counterfeit drugs has increased, especially with the spread of the internet network, the World Health Organization (WHO) states that its sphere of influence is not narrow. With the publication of the European Falsified Medicines Directive (EU FMD) in July 2011, the European Medicines Agency (EMA) entered a new period of European Union traceability regulations.

The Falsified Medicines Directive (EU FMD – Directive 2011/62/EU) provides coordinated European procedures to combat pharmaceutical falsifications and ensure that medicines are safe and under strict monitoring in trade circulation.

Among the measures are

  • Mandatory safety measures on the outer packaging of pharmaceuticals, such as a unique identity and an anti-tampering mechanism,
  • A logo that can be used across the EU to designate legitimate online pharmacies,
  • Stricter import regulations for active pharmaceutical components,
  • Wholesale distributors’ record-keeping standards have been strengthened.

The Directive also places an obligation on EU countries to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practices (GMP). It also places an obligation on the Commission to adopt, using delegated acts, the principles and guidelines of good manufacturing practice for active substances.

Firstly, GMP standards provide wide guidance, even though they are not mandatory instructions but rather guidelines based on fundamental principles. Validation of procedures, record keeping, operator training, and cross-contamination prevention are just a few examples. It is the manufacturer’s responsibility to develop the manufacturing process and quality programs following GMP standards, comprehend the rules, and appropriately identify process risks.

Since about 2019, all pharmaceutical products must completely comply with EU FMD requirements. EU countries with their systems must comply with the pharmaceutical traceability regulation until 2025.

EU FMD – Serialization

Under the EU FMD, key pharmaceutical traceability requirements include safety features such as a unique identifier in both human-readable and 2D data matrix format, as well as a tamper-evident label to be placed on individual packs of virtually all pharmaceuticals, and related compliance reporting. However, the practical implications of end-to-end serialization project implementation go far beyond installing serialization equipment and printing unique identifiers on product packages; implementations require accomplishing massive amounts of serialization data, integrating the data across supply chain links, and reporting the data in accordance with the European Medicines Verification System (EMVS) requirements.

The European Medicines Verification Organization (EMVO), which also supervisory control users in the Hub, requires pharmaceutical producers and parallel sellers to provide data to a central EU Hub. This will transmit data to appropriate data repositories managed by National Medicines Verification Organizations (NMVOs), who are in charge of end-user onboarding and system operation.

Marketing Authorization Holders (MAHs) must submit product data and serialized product pack data under EU FMD.

Tamper Evident Labeling

ISSTE-200 Carton Serialization with Tamper Evident Labeling

VISIOTT ISSTE-200 Carton Serialization and Tamper Evident Labeling Station prints 2D Data Matrix code which is assigned to each product compliant with EU FMD and stripping off the tamper-evident label on the carton. Through the tamper-evident label, product safety is ensured and detecting the intervention if exists becomes possible.

The code printed on the carton is read by a high-tech camera and the print quality is controlled. Readable texts are verified with OCR/OCV technology. Sensors control for the presence of the label after applying the tamper-evident label. If there is an error in the 2D code or the tamper-evident label, the cartons are removed from the line with a piston or air comb.


VBL-300 Vial Labeling and Serialization Station

Vial Labeling and Serialization Station VBL-300 serializes vials that are mostly in cylinder form and used as primary packaging for serum, vaccine, and injectable products. Especially in the cosmetics and pharmaceutical industries, the labeling and serialization operation of vials with liquid or lyophilized powder is high speed due to the small diameter of the vials. The quality production focus of these industries reveals the necessity for high-speed labeling operations to be precise and continuous.

You can perform your labeling and serialization operations for vial-type bottles, which are often used in industries such as pharmaceuticals and cosmetics, at high-speed and with high quality with VISIOTT Vial Labeling and Serialization Station.
The high-resolution printer on the serialization system can easily write the production-expiration date, lot, and serial number information on the label.

The high-resolution camera in the vial labeling serialization station measures the quality of the data matrix, reads and verifies the pharma codes. The readable text on the label is controlled and verified by OCR / OCV technology. Products that do not comply with the standards such as not having readable text or data matrix code are automatically removed from the line to the reject box.


EU FMD – Aggregation

Although the aggregation process has not yet been mandated by FMD, it is an application that increases the traceability system and, accordingly, the efficiency of the supply chain. Establishing the hierarchy of the products serialized by applying 2D code, with the transport unit (shrink, case, pallet, etc.) provides convenience for storage, shipment and recall processes. For aggregation applications, VISIOTT’s Horizontal Manual Aggregation Station MAS-100, Vertical Manual Aggregation Station MAS-200 and Semi-Automatic Aggregation Station SMAS-100 is an effective solution.

VISIOTT Solutions for Sustainable Manufacturing Operations

VISIOTT develops solutions with an innovative approach for the sustainability of production. VISIOTT PCW-100 Pharmaceutical Checkweigher performs a very important process for quality processes by weighing pharmaceutical cartons very precisely. With this sensitive weighing, the presence of the smallest component in the carton is also checked and the completeness of the medicine carton is guaranteed. PCW-100, which can measure pharmaceutical carton weights between 5 and 1000 g at a speed of up to 300 products/minute with an accuracy of 0.1, can be easily integrated into production lines.

VISIOTT Vision Inspection Technologies can meet the requirements of all operational and quality control processes of the pharmaceutical industry. The hardware of image processing technologies can be easily integrated into all operations. VISIOTT Vision Inspection Technologies (VIS-100) can perform the following quality inspections for the pharmaceutical industry:

  • Pharmacode control on the carton, label, package insert, films and cases.
  • Text inspection with OCR/OCV for lettering and embossing.
  • Detection of missing components in blister, carton and cases.
  • Performing level and open cover checks in liquid lines.

The operation of all these hardware, the management of operations and the notifications can be realized with software at Levels 2, 3 and 4. VISIOTT Line Manager (Level 2) software performs the control and communication of the stations. VISIOTT Plant Manager (Level 3) is the software that can assign work orders to lines and storage data with the information it receives from any EPCIS server or Level 4. For those who do not have a Level 4 solution, VISIOTT Plant Manager (Level 3) can also perform serial number assigning, master data management, work order management and notification operation management. The software that provides communication and coordination between different locations of companies, generates serial numbers and manages these numbers is VISIOTT Enterprise Manager (Level 4).

VISIOTT has successfully delivered and continues to deliver many projects that comply with EU FMD requirements. Customizable designs can be easily integrated into production lines. All-in-one solutions offered by VISIOTT are GMP, 21 CFR Part 11 and GAMP 5 compliant. Believing in long-term partnerships VISIOTT is always with its customers with spare parts service, 24/7 after-sales support and offices in various countries.







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