EU Issues Track-and-Trace Packaging Safety Rules to Take Effect in 2019

The European Medicines Agency and the European Commission published new track-and-trace safety requirements Feb. 10 affecting all drugmakers doing business in EU countries.

The rule, which takes effect in February 2019, mandates that manufacturers include a bar code as a unique identifier and an anti-tampering device in the packaging of most medicines.

The regulation also specifies interim compliance guidance for drug companies with existing or new marketing applications in the EU.

The regulation was hardly a surprise. Five years ago, the EU issued its Falsified Medicine Directive, and the recent action is part of the implementation of that directive. “The EU requirements have been expected and most manufacturers that sell products in Europe have been waiting for the delegated acts to be published,” Bill Fletcher, managing partner with Pharma Logic Solutions, tells IPRM.

However, the compliance effort could prove costly for drug manufacturers. Eli Lilly, for example, has committed more than $100 million to keep compliant with emerging track-and-trace standards in Europe and the U.S. Many pharma companies are expected to outsource tasks dealing with specific track-and-trace requirements, such as placing bar codes and anti-tampering devices on drug packages, now required by the EU.

Global drugmakers face several challenges in complying with the new rules, according to Fletcher. For example, the addition of a tamper-evident seal may affect the space available for traceability information because the seals compete for space on the carton, he notes.

In addition, drug manufacturers now must manage the allocation of serial numbers for more products and deal with related serialization information, including serialized child-to-parent aggregation.

Manufacturers also must supply information to a regulatory database. However, most commercial off-the-shelf serial number management systems include an option to post data to regulatory systems, and vendors will have more than enough time to respond to the new requirements with updates to their systems.  

“The EU’s package requirements are substantially equivalent to traceability labeling and machine readable symbol requirements in most other countries, including the United States,” Fletcher says.

However, data reporting mandates are very different in the U.S., where each trade requires the exchange of a transaction document comprised of transaction information, transaction statement, and in some cases, a transaction history. The EU model is similar to the Turkish model, in which traceability information is posted by the manufacturer into a state-controlled central database and items are verified when dispensed in pharmacies or hospitals. 

Read the regulations here: — Michael Levin-Epstein

$895 $695


Subscribe to International Pharmaceutical Regulatory Monitor and save $200 off the regular one-year price of $895 — plus receive a FREE CD copy of our webinar The 24 Elements You Need for a World-Class Quality Agreement — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — Each issue provides English-language texts of important, hard to obtain proposals, regulations, guidelines and other documents.

FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.