In brief

The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been included in a guide containing information on the documents required for the assignment of the NC. From now on it will be possible to send the NC application as soon as the final texts have been adopted by the applicant and the regulatory agencies. Finally, it will also be possible to present the European Commission’s decision in English.

In more detail

The Spanish Agency for Medicines and Health Products (AEMPS) has recently streamlined the processing of the application for the national code (NC) of those medicines that have been authorized through the centralized procedure. In addition, the AEMPS has published a guide on its own website in which it has updated and compiled all the information on the documents required to assign an NC, as well as any future modifications that may be made. These changes are included in the “AEMPS’ Annual Work Plan 2022”, whose objectives include the optimization of its organizational management.

Currently, the new “Guidance on the submission of the national code and blue box application for centrally authorized medicinal products and subsequent amendments to the registration” details that pharmaceutical companies have the option to submit the NC application from the moment their final texts and translations are agreed between the applicant company and the regulatory agencies. This date is equivalent to the 237th day of the calendar that is usually followed for the authorization of centralized medicines. It should be noted that this will give companies and the AEMPS more time to review the information, making it easier to remedy any errors that may arise prior to the authorization of the medicinal product by the European Commission.

Another aspect that should not go unnoticed is that, as a novelty, the AEMPS will also allow English and Spanish to be used in the process of sending the European Commission’s decision, facilitating the completion of the application by reducing this requirement. In this regard, it will also no longer be necessary to send the European administrative data as an attachment to the relevant NC application.

With regard to this procedure, the list of modifications that involve the issuing of an official letter signed by the AEMPS to endorse the change has also been added. The figure of the batch releaser has also undergone changes regarding the procedure for its update. It will now only be necessary to attach an official document to endorse the identification of this figure without the need to add a NeeS sequence to carry out the update.

Detailed information on the new “Guidance on the submission of the national code and blue box application for centrally authorized medicinal products and subsequent amendments to the registration” can be found by clicking on this link.

Copyright © 2022 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.


Montserrat Llopart leads the Healthcare and Life Sciences practice in the Baker McKenzie Barcelona.


Javier Saladich can be reached at