The AEMPS approves that manufactures use folding cartons already pre-serialized by a third party

“The Spanish Agency of Medicines and Medical Devices (AEMPS) has released a series of recommendations for the pharmaceutical industry to apply the requirements of Directive 62/2011/EU”

The operation of the anti-counterfeiting directive is in progress. Even though it will not be until February 2019 when the norm is applied, the Spanish Agency of Medicines and Medical Devices has recently provided new indications for the implementation of safety devices in folding cartons of medicines.

One of the premises on which the directive is based, is the adaptation of folding cartons of certain medicines and their classification through a unique identifier and a device against manipulation.

Upon the Delegated Acts of this directive, the AEMPS has recently announced new decisions that clarify specific issues regarding the application of the Directive.

The National Drug Identifier

Regarding the unique identifier, it has been considered appropriate the inclusion of the National Drug Identifier, and therefore, it will be an additional requisite in the member states where the drug is marketed.

The National Drug Identifier will be placed in the upper right corner of the folding carton’s main face or in the upper right corner of the blue box. For coding purposes, the information will be included on the two-dimensional barcode (datamatrix).

Notification of safety devices in the folding carton

The AEMPS has structured a notification system to control compliance with the regulation and the correct adaption of the safety devices.

In this way, those responsible for the commercialization must notify of the update and inclusion of these devices in the folding carton’s artwork through the application REFAR.

They will also have to submit the artwork if changes are made to the design of the folding carton, such as the elimination of authorized content by the AEMPS and changes that are not related with the implementation of the device (logo, font…)

For drugs authorized by European procedures, the usual process of notification and presentation of the authorization will be followed at a national level to ensure the compliance with the measure.

Sales and distribution

Drugs that have the unique identifier incorporated as of February 9, 2019, will have to be legible and uploaded in the corresponding repositories.

On the other hand, those that are released before that date and do not contain the relevant safety devices, may be marketed, distributed and dispensed until its expiration date.

Pre-serialization by third parties

The Spanish Agency of Medicines and Medical Devices has announced a new modification in which the handling of pre-serialized folding cartons by third parties will be accepted, provided the indicated Delegated Regulations are followed.

The parties involved must have a written contract specifying the responsibilities of both parties, as well as the verification of the correct execution capacity of the supplier of folding cartons.

Coexistence of codes

A specific regulation has not yet been introduced, but the gradual incorporation of the two-dimensional code implies coexistence with the barcode of the seal coupon, which should be dealt with, if necessary, later by the AEMPS.


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