Update on Serialization

Update on Serialization

Update on Serialization

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 features as part of the marketing authorizations for some medicinal products for human use.

Two safety features must be implemented on the packaging of certain medicinal products:
· Unique identifier (UI): two-dimensional code that must incorporate the National Code (NC) for Spain.
· Anti-tampering device (ATD): it will certify that the medicinal product has not been manipulated.

An upcoming Royal Decree will modify the RD 1345/2007, which regulates the authorization, registration and conditions of the medicinal products of human use, in order to include the serialization regulation. A draft version of the Royal Decree was issued on November 2018 and it will come into force on 9 February 2019.

 

Should all medicinal products contain these safety features? [2]

No. The following criteria are applicable:
– Medicinal products subject to medical prescription but exempt from containing safety features 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.

This is applicable to all presentations of authorized medicinal products, without prejudice to whether they are currently marketed or not.

 

How should the changes to the labelling and mock-ups 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
· Exempt of fees

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
· 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
Additionally, there are the following national requirements for Spain:

1. National Art. 61(3) Notification – safety feature
Submission of updated labelling and mock-ups including safety features (UI + anti-tampering device) through AEMPS electronic portal (RAEFAR) applicable to marketed products subject to serialization.
The notification should be done at the time of effective implementation and, in any case, before February 9th 2019.

2. Upload of information concerning GTIN and expiration date[3]
For those marketed medicinal products containing the GTIN as PC, notification of the GTIN codes and the expiration date of the last batch of non-serialized has to be performed through the electronic portal. Not applicable for NTIN.
The notification should be done at the time of effective implementation and, in any case, before February 9th 2019.

3. SEVeM contract
All MAHs owning serialized products marketed in Spain must formalize a contract with the Spanish NMVO, SEVeM, before February 9th 2019.

 

When do the safety features have to be implemented?

Implementation date is 9 February 2019.
Medicinal products released after this date should contain the safety features mandatorily.
Medicinal products released before this date can be without the safety features until their expiration date.

 

Which are the applicable fees?

emVo (European Medicines Verification Organisation) charges an entry fee when creating the account in their system. No further fees 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. The fees are calculated according to the annual turnover for sales of serialized products of the previous year.

 

Asphalion can support you with the revision of updated mock-ups, management of the notifications and upload of information through the national portals and management of the contract and communications with SEVeM.

If you have any question, do not hesitate to contact us at: [email protected]

 


[1] Informative note MUH, 10/2017 (AEMPS) published on July 12th, 2017 – IMPLEMENTACIÓN DE LOS DISPOSITIVOS DE SEGURIDAD EN LAS AUTORIZACIONES DE  OMERCIALIZACIÓN DE LOS MEDICAMENTOS DE USO HUMANO

[3] Informative note MUH, 12/2018 (AEMPS) published on December 14th, 2018 – NUEVOS CAMPOS EN LA APLICACIÓN DE NOTIFICACIÓN DE COMERCIALIZACIÓN DE  EDICAMENTOS PARA LOS MEDICAMENTOS QUE DEBAN LLEVAR DISPOSITIVOS DE SEGURIDAD

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