Notice to Pharmaceutical Companies
We inform you that AIFA adheres to the eSubmission Roadmap adopted by the HMA and that, therefore, in accordance with Annex 2 of the HMA eSubmission Roadmap, starting from 1 January 2019, the obligation to use the electronic Common Technical Document (eCTD) extends to all regulatory activities concerning marketing authorizations issued with a national procedure.
For more information on the timing of the mandatory use of eCTD, Electronic Application Forms (eAF), please refer to the portal dedicated to eSubmission.
Attached the document:
How to submit applications for AIC, variations, renewals and ASMF
TechFile-Manager, for Medical Devices, is developed in full compliance with the legislation in force for the European community as illustrated in REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC.
The definition and structure of the Technical File is provided in Annex II "TECHNICAL DOCUMENTATION" and in the following subparagraphs, in Annex III "TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE" and in Annex IV "EU DECLARATION OF CONFORMITY" and the organizational model useful to deal with the quantity of documents to be produced - and that will become mandatory from May 2021 - needs a computer tool comparable to a document management on the eCTD model in use in the pharmaceutical world.
TechFile-Manager is a tool equipped with the necessary features for validation including:
• User profiling: guarantees access and rights to both the various menu functions and documents;
• Versioning: every change made to every single paragraph of each edition is archived with the possibility of consultation and retrieval;
• Audit Trail: keeps track, with the possibility of consultation by authorized users, of the main operations carried out on the application.
In addition, the system meets the requirements of the Notified Body and is developed according to the guidelines in Gamp5.
TechFile-Manager supports the entire Technical File document cycle
By inserting the main metadata, which will subsequently be proposed and/or reused in subsequent editions (Name of Medical Devices, N°. Version, Holder, N°. Notified Body), the application will develop the entire document structure of which the Technical File is composed by inserting for all paragraphs the correct title, header and footer in the desired representative style; in addition, each document may possibly incorporate predefined templates (E.g. General Safety Requirements).
TechFile Manager generates the electronic Technical File without user involvement
Using the appropriate function from the main menu, the application automatically publishes, which creates the package to be sent to the Notified Body, consisting of the folder tree, the relevant paragraphs converted to pdf format with the relocation of hyperlinks, the indexing of chapters and subchapters and, above all, an Index.xml to use to navigate the Electronic Technical File.
TechFile Manager manages the Life Cycle
Starting from the second electronic edition of the Technical File, the application provides a sophisticated management of the "life cycle" that, in addition to automatically relocate all the hyperlinks present in the initial edition, through the identification of newly inserted or modified paragraphs, creates and/or increases, always without the intervention of the user, the n° of revision for the aforementioned paragraphs.
Techfile-Manager manages the tracking of consolidated editions
Always starting from the second edition of the Technical File, once generated the electronic structure, the application will store in a specific directory the files in pdf format highlighting the changes occurred in the paragraphs that are part of the Technical File.
To finish, we want to underline that the system is developed with the collaboration of specialists working in the field of Medical Devices and especially in the implementation and subsequent management of the Technical File.
Therefore, the result is a constantly careful design to meet the most complex application needs entrusting the system with the correct interpretation of the legislation to allow users to focus exclusively on professional content of their role facilitating and streamlining day-to-day activities impacting on the documentary management of the Technical File and making it easier the consultation for Notified Bodies.