FALSIFIED MEDICINES DIRECTIVES

The February 2019 EU Falsified Medicines Directive (EU FMD) deadline is fast approaching, so it’s crucial that pharma companies and their supply chain partners be well versed on the compliance standards to ensure a smooth implementation process.

For many months, OPTEL’s serialisation experts have been discussing FMD regulatory requirements with pharma companies and their supply chain trading partners around the globe. Below is a list of commonly asked questions and our responses, which we hope will enable pharmaceutical organisations to navigate the FMD requirements with greater ease.

WHAT IS EPCIS?

EPCIS is the standard messaging language adopted by the pharma industry to address the sharing, passing and management of serialised data required for compliance with the EU FMD and U.S. Drug Supply Chain Security Act (DSCSA).

DOES THE EU HUB RECEIVE AND STORE ALL OUR COMMISSIONED SERIAL NUMBERS?

The European Hub serves as the principal place for the storage of master data and as a gateway for the transmission of manufacturer data to the national systems of EU member countries. The national systems serve as the verification platforms that pharmacies or other registered parties, such as wholesalers, self-dispensing doctors or hospital pharmacies, can use to check a product’s authenticity.

CAN MY CPO/CMO PARTNER SEND/REGISTER MY DATA WITH THE EU HUB?

No, the brand owner or Marketing Authorisation Holder (MAH) must be the party that registers all the commissioned data with the European Hub.

ARE THERE FEES ASSOCIATED WITH THE EU AND NATIONAL SYSTEMS?

Yes. Please see the European Medicines Verification Organisation (EMVO) for details about a one-time fee for the European Hub and the annual fee for national systems.

ARE REGULATORY REQUIREMENTS THE SAME IN THE U.S. AND EU?

No, but there are many commonalities. For example, EPCIS is not prescribed in either regulation, even though using a standardised messaging format is beneficial in both cases. The U.S. uses a Track&Trace model (i.e., data is passed throughout the supply chain), while the EU uses a verification model (i.e., data is passed to the central European Hub and authenticated at the market/national level).

The EU FMD requires tamper-evident packaging; the U.S. DQSA does not.

WHAT IS THE DEADLINE FOR COMPLIANCE IN THE EU?

February 9, 2019, is the deadline, with exemptions for Belgium, Italy and Greece, which allow a six-year grace period.

HOW LONG MUST WE STORE THE DATA?

The EU FMD mandates that data must be retained in the European Hub for a period of batch expiry date plus one year or five years, whichever is the longest.

WHAT IS THE ENCODING REQUIREMENT?

The data carrier is a 2D Data Matrix and a human-readable unique serial number, combined with the manufacturer product code, batch number and expiration date. A fifth element, such as a national reimbursement code, may be required in certain markets.

IS AGGREGATION REQUIRED?

Aggregation is not required by law, but industry participants have discussed including it to gain a business advantage.

WHEN DOES THE VERIFICATION TAKE PLACE?

  • At least once, at the point of dispensation
  • Risk-based verification takes place at the wholesale level
  • When medicinal products are returned to wholesalers

WILL GLOBAL TRADE ITEM NUMBERS (GTINs)/SERIALISED GLOBAL TRADE IDENTIFICATION NUMBERS (SGTINs) BE USED?

Yes, GTINs will be used, but some national systems may require an additional national code.

WHAT IS THE REQUIREMENT FOR SERIAL NUMBERS?

  • Alphanumeric and randomized
  • Sparsity rule 1:10,000

HAVE ADDITIONAL QUESTIONS?

Please contact us and someone from our team will be in touch with you today.