This note establishes the recommendations of the Spanish Agency of Medicines and Medical Devices (AEMPS) that should be taken for the implementation of the safety devices as part of the marketing authorisations for some medicinal products for human use.
Two safety devices must be implemented on the packaging of certain medicinal products:
– Unique identifier (UI): two dimensional code containing the product code (either GTIN or NTIN are applicable for Spain), serial number, batch number and expiry date. For Spain it must incorporate the National Code (NC).
– Anti-tampering device (ATD): it will certify that the medicinal product has not been manipulated.
Should all medicinal products contain these safety devices?
No. The following criteria are applicable:
–Medicinal products subject to medical prescription but exempt from containing safety devices as indicated in the Annex I of the regulation (UE) 2016/161.
–Not applicable for non-prescription medicinal products, unless they are included in Annex II of the current regulation.
These recommendations apply to presentations of authorized medicinal products, without prejudice to whether they are currently marketed or not.
How should the changes to the labelling be notified in Spain?
Different scenarios have to be taken into account depending on the kind of modification performed (see complete publication):
a) Changes in the packaging only related to the safety features implementation:
· Submission of an Art. 61(3) notification
· Upload of mock-ups through a specific tab in RAEFAR at the time of effective implementation and before February 9th, 2019
· Exempt of fees
Note: It is acceptable reorganising the information contained in the box as far as the design (font size, line spacing,…) is not affected.
b) For changes not only related to the safety features implementation (e.g. change of the design of the outer packaging, etc):
· Type IB C.I.z variation submission (Lay-out change variation)
· Fees for a Type IB variation
c) For products that do not have outer packaging:
· Variation to include the information related to anti-tamper devices in Module 3
· Applicable fees
When do the safety features have to be implemented?
Implementation date is February 9th, 2019.
Medicinal products released after this date will contain the safety features mandatorily.
Medicinal products released before this date without the safety devices can be left in the market until their expiration date.
Any fees will be charged?
emVo (European Medicines Verification Organisation) charges an entry fee when creating the OBP (On-Boarding Partner) account in their system. No further fees payments are applicable for emVo, just to the national repositories, if applicable.
Additionally, in the case of Spain, SEVeM (Spanish National repository) charges an entry fee and an annual fee. No fees will be charged until 2019, which is the implementation date. The amount of the fees is still to be determined.
In Asphalion we have large experience in the preparation of maintenance applications including variations, renewals or notifications, and its submission. We can support you on the maintenance of the product during its life cycle to optimize coordination and execution.
* Informative note MUH, 10/2017 (AEMPS) published on July 12th, 2017 – IMPLEMENTACIÓN DE LOS DISPOSITIVOS DE SEGURIDAD EN LAS AUTORIZACIONES DE COMERCIALIZACIÓN DE LOS MEDICAMENTOS DE USO HUMANO