Italy: AIFA simplified the procedure for applications of new MA for generic and hybrid medicines

In brief

On 30 May 2023, the Italian Medicines Agency (AIFA) announced that, starting from the Scientific Technical Committee (STC) meeting in June 2023, a new simplified procedure will apply to applications for new MAs under national, mutual recognition and decentralized procedures submitted under Article 10(1) (generic medicines) and Article 10(6) (hybrid medicines) of Legislative Decree No. 219/2006 in order to streamline the relevant registration process.


Contents

Key takeaways

In particular, said procedure applies to applications for new MAs of generic and hybrid medicines in cases where the packaging of the medicine to be authorized (i) is perfectly comparable to that authorized for the reference medicine; (ii) falls within the range of that authorized for the reference medicine (in terms of dosage units and under the same form/strength); or (iii) is outside the range of those authorized for the reference medicine (in terms of dosage units and under the same form/strength) but it is perfectly comparable to the packaging authorized for another generic of the same reference medicine.

Under the simplified procedure, applications for new MAs of generic or hybrid medicines will be reviewed without the need to obtain the opinion of the STC. The new procedure also provides that all medicines to be authorized whose reference medicine has packaging classified in Class A or H will be classified in Class Cnn.

Lastly, for Cnn classified medicines, the application for the pricing and reimbursement negotiation can be submitted to AIFA's Health Technology Assessment Department following the publication in the Official Journal of the resolution granting the MA.


Copyright © 2024 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.