Serialisation

The key aspects of the Anti-Counterfeiting Directive

Throughout this year, the Spanish Drugs Verification System (SEVEM) has been developing an implementation plan for Directive 62/2011/EU, and have begun to conduct the first tests of the anti-counterfeit system in pharmacies.

As of next year, the system will begin to progressively integrate to verify that the drug information manager NODOFARMA, correctly connects all the implicated links of the production and distribution chain.

It is foreseen that the pharmaceutical industry will begin to market drugs with the unique identifier code implemented during 2018. In this way, it is planned that by February 9, 2019, all the agents implicated in the system are expected to comply more efficiently with the requirements of the Directive.

Following, we propose a simple graphical guide of the major points that the industry should know on the Directive to begin implementing the requirements effectively.

serializlación-medicamentos

WHERE DOES IT APPLY?
  • To all prescription drugs except those specified in Annex 1 of 2016/161
  • Also applies to Omeprazol 20 mg and 40 mg

 

envases-serializacionWHAT DOES THIS DIRECTIVE REQUIRE?

  • Include a tamper evidence system in the external packaging
  • Serialize packaging with a unique variable identifier, a Datamatrix

 

envases-serializacion-deadline

WHAT DEADLINES MUST I MEET?
  • February 9, 2019 is the established date for which all prescription drug marketed in the European Union (except Belgium, Greece and Italy) will have to comply with the regulation

 

The institutions have already introduced the steps to be followed. Now, it is up to manufacturers, distributors and dispatchers to adapt their infrastructures and prepare to adopt the Directive.

We display below a chronological guide of what will be the most important actions for the industry until the deadline of the Directive:

 

timeline-03

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