Falsified medicines directives – preventing drug falsification
Falsified medicines directives worldwide – an overview
Overview of falsification guidelines worldwide
Legislators all over the world have resolutely opposed the dangers of falsified drugs for consumers and companies by adopting national and supranational falsification directives. Compliance with the regulations enables pharmaceutical manufacturers and packaging service providers to ensure that their products can be distributed seamlessly in the target markets and falsified low-cost products are reliably removed from those markets. There are multiple falsification directives worldwide at various stages of implementation, with partly differing requirements.
In this overview, you will find out where the similarities and peculiarities lie.
- Tamper-Evident seal
- GS1 international
Coding: Other countries, other labelling of medicines
All falsification directives require an individual product identification number on the drug packaging. In addition, most of the directives include the expiry date for the drug as well as a batch number and possibly a serial number. The format of these labels can vary widely, but they must include human-readable plain text as well as a machine-readable barcode. The same applies to the type of product identification number – the GTIN format of the GS1 is often required, sometimes an ID number in the NTIN or in country-specific formats is specified (e.g. PPN in Germany, CIP in France, KDC in Korea, CNK in Belgium, AIC in Italy, etc.). The product identification number usually contains the following information: A country prefix, the company number, article number and a check digit.
Tamper-Evident seal: Special feature of the EU Falsified Medicines Directive
The tamper-evident seal is required for prescription-only drugs in countries which are subject to the EU Falsified Medicines Directive that entered into force on February 9, 2019. The seal prevents subsequent manipulation of the packaged medicine or the concealment of falsified drugs in original packaging. The product must not be dispensed to the customer if the seal is damaged or opened when sold.
The solution for the tamper-proof sealing of drug boxes:
The solution for the semi-automated aggregation of drugs:
Aggregation: Track & Trace throughout the complete supply chain
Only some directives, e.g. in Russia or Turkey, require an aggregation that allows the traceability of a single product pack along the entire transport route and across several packaging levels. Countries such as the USA still reserve the right to make this decision, in the EU and some other countries, aggregation is voluntary. In Brazil, it must be possible to trace every single box across the various aggregation levels from 2021. Here too, the type of coding may vary depending on the country. Although in some falsification directives – like the European one – aggregation is voluntary from a purely legal point of view, it may nevertheless be desired by customers such as wholesalers and hospital pharmacies. They accept what are sometimes large deliveries in pack or pallet size, where the ability to verify a complete delivery straightaway at goods receipt considerably facilitates their flow of goods.
With our aggregations solutions TQS-CP and TQS-CP Bottle this is exactly what you’re providing your customers with: Drugs that are verifiable at pack and pallet level. The operator fills the shipping box in layers. The integrated camera captures the codes of the medicine boxes after each layer. When the box is filled and the aggregation level is complete, the TQS-CP automatically creates the correct label. This works on multiple aggregation levels.
GS1 international – guardian of the identification numbers
56 countries – 72 upcoming deadlines:
INFORMATION GRAPHIC SERIALISATION PHARMA:
All global serialisation requirements at a glance – compact and comprehensible
EUROPE’S FALSIFIED MEDICINES DIRECTIVE 2011/62/EU AND WHAT IT MEANS FOR MANUFACTURERS IN THE EU
In 2011, the EU Falsified Medicines Directive 2011/62/EU was published. It applies to all prescription-only and selected OTC drugs in the European Union since February 2019. The non-EU countries Iceland and Norway are also subject to the European Falsified Medicines Directive. Italy, Belgium and Greece serialised even before February 2019. Not in accordance with the EU directive, but using vignettes or bollini (stickers). They have a further six years in which to implement the EU directive in full. Drugs which do not bear the necessary security features according to the EU FMD (Falsified Medicines Directive) may no longer be sold in the EU. In practice, the pharmacist will scan the individual pack before dispensing it to the patient. The drug must not be dispensed if the scan returns an error message.
Need more information about the EU-FMD?
Details of EU Directive 2011/62/EU
According to the FMD, each single package must contain the following information in plain text and encoded in a machine-readable 2D matrix code:
- Product identification number, in the format GTIN, NTIN (or PPN for Germany)
- Batch number
- Batch number
- Individual serial number of the single pack
- If necessary, national healthcare reimbursement numbers, NHRN, for reimbursement by national healthcare insurers
In addition, single packs must be protected against manipulation with an intact tamper-evident seal.
DSCSA – the Drug Supply Chain Security Act ensures safe medicines in the USA
The US falsification directive DCSA is part of the FDA’s DQSA (Drug Quality Security Act). It was signed by the President in 2013 and is expected to be fully implemented by 2023. Since 2015, manufacturers and retailers of prescription-only and reimbursable drugs have been obligated to provide the necessary information at batch level and to record all transaction data until the medicine is finally dispensed in the pharmacy. Complete traceability of the batch numbers of medicines makes it possible to quickly recognise and seize not only falsified but also stolen batches of drugs. In this case, staggered deadlines apply to the various stakeholders, producers, packaging service providers, wholesalers and vendors. From November 2023, the obligation will be extended to the labelling of medicines in single packages. The transitional period for the labelling of single packages starts from November 2018. Corresponding specifications previously applied in individual states and are now being replaced by the US-wide regulation.
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This information is required by the DSCSA
From November 2018, the following information must be shown on every individual pack in the form of a 2D matrix code:
- National product identification number in GTIN format
- Individual serial number of the single package
- Drug expiry date
- Batch name of the medicine
COUNTERFEITING DIRECTIVE IN SOUTH AFRICA: SERIALISATION OF SECONDARY AND TERTIARY PACKAGING
South Africa has joined the global fight against counterfeit medicines. Pharmaceutical exports from the EU to South Africa exceed €1 billion a year, making the recent coding and serialisation directives in South Africa a major change for European pharmaceutical manufacturers. Companies shipping to South Africa will have to reorganise their packaging processes to meet the requirements. The serialisation of secondary and tertiary packaging is expected to be completed by 2022. The gradual implementation of the regulation aims to give pharmaceutical companies sufficient time to prepare.
Law 61-FZ: Introduction of a falsification directive in Russia
The falsification of drugs and the black market are a serious problem in Russia. In response to this, the State Duma passed Law 61-FZ on the circulation of medicines, which is intended to increase drug safety. A pilot project limited to a few essential active substances, which monitored the manufacturing and supply chain of pharmaceutical products sold over the counter in the Moscow and St. Petersburg areas, ran until the end of 2017. The aim was to reliably identify falsified drugs. From January 2020, all prescription-only drugs are to be serialised and aggregated.
Falsified drugs directive in Brazil: Track & Trace with SNCM
The Brazilian health authority ANVISA is a step ahead. In 2014, it adopted the SNCM’s abridged regulations for a Track & Trace system used to monitor manufacturing and the supply chain of drugs. Similarly to the European and American systems, the product identification number, serial number, batch number and expiry date of the drugs should be printed on the packaging. After some delays in the implementation, the regulation currently applicable specifies 1 April 2022 as the deadline for comprehensive implementation of the “Sistema Nacional de Controle de Medicamentos”.
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Implementation of the falsified medicines directives – how do packers and pharmaceutical professionals accomplish this?
Compact solutions where space is tight: Track & Trace on the Fast Track
Free space is often in short supply in the manufacturing and packaging lines of pharmaceutical manufacturers and contract packagers The very compact WIPOTEC-OCS machines make it easy to integrate important functions in existing lines with a minimum of space. The best part of this: with our Fast Track solutions, your serialisation will be up and running within only 6 weeks.
The TQS-SP enables the serialisation and tamper-evident labelling of individual drug packs in the smallest of spaces. With the TQS-HC-A with Tamper-Evident you can perform three tasks fully automatically on a length of 1800 m: checkweighing, serialising and labelling.
- Reliable compliance with international falsification directives
- Even where space is at a premium
- Solution within six weeks of ordering
- Modular, scalable and easily integrated in existing lines
Single Pack Serialisation
Serialisation | Tamper-Evident | Weighing