Notifications about anti-tampering device (ATD) or devices to prevent tampering on packaging of existing drugs that do not fall under the Falsified Medicines Directive

Within the framework of the Falsified Medicines Directive, FMD) which is effective as of February 9, 2019, all drug packaging falling under this legislation must be equipped with an anti-tampering device (ATD). Packaging of these drugs not subject to this obligation may also have an ATD. The marketing authorization holder must submit a request for this to the FAMHP.

How does one apply for an anti-tampering device (ATD)  for drugs that do not fall under the Falsified Medicines Directive.
When an ATD is to be attached or is already present on a package of a drug that does not fall under the Falsified Medicines Directive, you must submit an application via e-mail, using the
 Excel-template. You must write a motivation why this protection appears to be necessary.

Send the template to enreg.reg@fagg-afmps.be with the subject “Update ATD”. All columns must be filled in for each package. You can find the information requested in the medicinal products database.

If you decide to remove an ATD, you must use the same template and send it to the same address.

When to report the addition of an ATD?
It is important to make notification of this as quickly as possible. The Falsified Medicines Directive prohibits the addition of an ATD if the competent government has not made an explicit decision regarding this.

The presence of an ATD is part of the processing of the file within the framework of a new application for approval for a drug or an OTC switch.

More information
Falsified Medicines Directive 2011/62/EU

 

Last updated on
29/01/2019