FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS Federal Agency for Medicines and Health Products (FAMHP) 27.03.2007 Zero Tolerance info session FAMHP.

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1 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS Federal Agency for Medicines and Health Products (FAMHP) 27.03.2007 Zero Tolerance info session FAMHP 27/03/2007 1

2 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 2 Introduction - Program 1. The Zero Tolerance Checker 2. The CTD Tree Structure 3. Errors and Corrections 4. Zero Tolerance Statistics 5. Future portal applications 6. Secured access for portal applications

3 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 3 The Zero Tolerance Checker (Mr. Hennion)

4 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 4 Belgian e-submission Structure (BeSt) check Goals of this module Make it easier to handle a dossier => make it easier to find all necessary information in a dossier Do a correct check on the structure of a dossier sent in by enterprises Give accurate, up to date and clear feedback to the enterprises Stimulate to grow to a situation where all dossiers are real eCTD’s (with backbone and checksum) Make the check of a dossier up to date, conform all latest guidelines Make it possible to check complex dossiers as well

5 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 5 BeSt Verification – check implementation How it is (and will be) implemented Automatic rejection of dossiers not yet implemented

6 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 6 BeSt Verification - Example

7 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 7 BeSt Verification - report summary With clear color coding: Folder or file completely OK Folder contains files and should not (perhaps files not in lowest level) Folder or file name contains illegal characters The name of the file or folder is not conform the eCTD-guidelines This document has an extension that is not allowed in an eCTD-folder This file can not be checked accurately, because it is in an incorrect folder (so there is no rule to check it) And a clear summary to the user and the enterprise

8 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 8 BeSt Verification – future What comes in later releases Automatic rejection of dossiers and in that case sending a rejection mail instead of a confirmation mail New releases of the module when the guidelines are updated => keep the module up to date New release of the offline checker => keep also the offline checker up to date http://www.fagg.be/ http://www.fagg.be/

9 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 9 BeSt Verification – Offline checker

10 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 10 BeSt Verification – Website http://www.fagg.be/

11 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 11 BeSt Verification – Folder structure

12 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 12 The CTD Tree Structure (Mrs. Ameye)

13 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 13 Reminder... folder structure You are familiar with the e-CTD folder structure: 0000 m1 eu 10-cover 11-toc 12-form 13-pi... m2 m3...

14 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 14 Reminder... folder structure Tree-structure should always be respected Folder names should not be modified Delete empty folders  Use tree-structure “as is”  Empty e-CTD structure available on the FAMHP website  Zero tolerance for folder structure and folder/file names

15 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 15 Reminder... File names File naming conventions: EU module 1 specification (v 1.2.1, Oct 2006) See Notice to Applicants (www.ec.europa.eu/enterprise/pharmaceuticals/eudralex)www.ec.europa.eu/enterprise/pharmaceuticals/eudralex ICH E-CTD specifications for modules 2 –5 (v 3.2, Feb 2004) See ICH guidelines on CTD (www.ich.org)www.ich.org

16 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 16 File naming conventions Filenames = fixed and variable components Components are separated by a hyphen No hyphens or spaces within each component Fixed components are mandatory Variable components are optional and further define the files Extension

17 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 17 File naming conventions A typical filename consists of First component: cc (country code) or common Second component: document type code Third component: variable (clear, logic, no spaces, no hyphens, no dots,...) The format of the file is indicated by the: File extension = “.ext”

18 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 18 File naming conventions Always use lower case ! Conclusion: a file name is always of the type: cc-fixedcomponent-var.ext e.g. be-cover-xxtablets10mg.pdf common-spc-xxtablets10mg.doc

19 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 19 “Wonderpil” Practical example: correct tree-structure correctly named empty files a 100% folder & file score through the checker Is as complete as possible combines different types of dossiers all folders are not necessary present at the same time for a particular submission. e.g. 1.3.4 (readability): either the “be” folder, either the “common” folder but not both. Available on the FAMHP website

20 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 20 “Wonderpil” – how to work with it ? Leave out the folders which are not applicable for your submission For each of your documents: Click on “File”, “Save as” Go to the correct folder in the Wonderpil- structure and select the correct file name Click on “save” and “replace” Where a variable component is present: change it according to your dossier Delete empty folders

21 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 21 GOOD LUCK !

22 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 22 Errors and Corrections (Mrs. De Paepe) (Mr. Vanhove)

23 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 23 Error 1: Name contains illegal characters (only lower cases, digits and ‘-’ are allowed) Possible FOLDER errors

24 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 24 Error 2: Folder is not a correct CTD-folder Possible FOLDER errors

25 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 25 Possible FOLDER errors Error 2: Folder is not a correct CTD-folder

26 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 26 Error 1: Name contains illegal characters (only lower cases, digits and ‘-’ are allowed) Possible FILE errors

27 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 27 Possible FILE errors Error 1: Name contains illegal characters (only lower cases, digits and ‘-’ are allowed)

28 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 28 Error 2: Name of the file is not according the file naming conventions Possible FILE errors

29 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 29 Possible FILE errors Error 2: Name of the file is not according the file naming conventions

30 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 30 Error 3: Name of the file cannot be checked correctly because it’s in a non eCTD folder Possible FILE errors

31 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 31 Zero Tolerance Statistics (Mr. Lhoir)

32 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 32 Overview of folder and file score 2007

33 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 33 Overview of folder score expressed in %

34 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 34 Zero Tolerance Road Map 27/03/07: Checker and wonderpil tree structure available on website. 27/03/07 – end june 07: Self testing period – ad random sampling for dossier rejection. End june 07: Start zero tolerance dossier rejection.

35 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 35 Future Portal Applications (Mr. Lhoir)

36 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 36 Portal Applications - eMeDI electronic Medicinal Dossier Interface (eMeDI) What? View online status of submitted e-dossiers. Status? Pilot fase ongoing : Change Requests based on industry input being analysed. Go-live? To be determined.

37 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 37 Portal Applications - eSubmission eSubmissions What? Upload and/or data entry. Status? Validation of design with end-users ongoing. Go-live? To be determined.

38 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 38 Secured access for portal applications (Mrs. Daems)

39 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 39 Principes de base Que permet le User Management Entreprises ? Identification – Authentification de l'utilisateur Vérification de l'autorisation d'accès à l'application Vérification d'accès aux données de l'entreprise.

40 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 40 "Force" du User Management Entreprises Système simple Offrant une solution juridique et technique pour consulter, déclarer et modifier des données "sensibles", grâce à : - un système technique hautement sécurisé - une procédure administrative avec des contrôles adéquats - la gestion (pro)active par les services Identification – Gestion des Accès - la validation juridique du système (législation – Comité de surveillance – règlement d'utilisation).

41 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 41 L'accès sécurisé A quoi sert l'accès sécurisé ? Certaines applications qui se trouvent sur le portail de la sécurité sociale ne sont accessibles que dans un environnement sécurisé car elles permettent d'accéder à ou d'introduire des données sensibles (cf législation sur la protection de la vie privée). D'autres applications – qui ne sont pas hébergées sur le portail de la sécurité sociale - font également appel au même système d'accès sécurisé : le User Management Entreprises. Comment accéder à un environnement sécurisé ? Vous avez besoin d'un nom d'utilisateur et un mot de passe. Certaines applications demandent un niveau de sécurité supplémentaire (un certificat par exemple).

42 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 42 L'accès sécurisé Comment obtenir ces nom d'utilisateur et mot de passe ? Tout d'abord, vous avez besoin : de votre numéro d'entreprise et/ou d'ONSS du numéro de registre national de la personne qui jouera le rôle de gestionnaire local. Vous remplissez une demande on-line accessible via une application qui se trouve sur l'url suivant : https://www.socialsecurity.be/autocel/frontend/actions/Entrer.do?langue=fr https://www.socialsecurity.be/autocel/frontend/actions/Entrer.do?langue=fr Via ce formulaire électronique, vous allez pouvoir désigner un gestionnaire local au sein de votre entreprise (attention, ce formulaire devra, soit être renvoyé par la poste, soit être signé par carte d'identité électronique). Vos nom d'utilisateur et mot de passe vous seront envoyés par la poste.

43 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 43 Le gestionnaire local Qui peut être gestionnaire local au sein de mon entreprise ? Quelles sont ses responsabilités ? Le gestionnaire local : Est la personne de contact "responsable" au sein de l'entreprise pour : - le développement et l'organisation des accès - la sécurité des données générées et consultées - la gestion des codes d'accès + clés privées & certificats - la gestion des utilisateurs. Il doit remplir des conditions particulières : être sous l'autorité directe de l'entreprise ou membre de son Conseil d'Administration. Il reçoit accès aux applications sécurisées correspondant au profil de son entité (employeur, prestataire, …).

44 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 44 Le responsable Qui peut se porter responsable pour mon entreprise ? Quel est son rôle ? Le responsable : Est la personne qui a le droit légal d'engager, par sa signature, son entreprise. Sa fonction : être administrateur, chef d'entreprise ou associé (publication au Moniteur Belge). C'est lui/elle qui signe le formulaire de demande accès pour le gestionnaire local de l'entreprise.

45 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 45 Les utilisateurs Qui peut créer les utilisateurs ? Une des responsabilités du gestionnaire local est la création et la gestion des utilisateurs. Ces utilisateurs doivent faire partie de l'entreprise pour laquelle le gestionnaire local agit et posséder un numéro de registre national. Comment créer un utilisateur ? Cette procédure se fait directement on-line dans la rubrique "gestion des utilisateurs" qui se trouve sur la page d'accueil du gestionnaire local. Il décidera lui-même à quelle(s) application(s) les utilisateurs auront droit.

46 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 46 Flux de connexion au portail

47 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 47 Hiérarchie d'une entreprise Entreprises nr. BCE-KBO Employeurs ONSS ou ONSS APL nr. ONSS-ONSS APL – BCE-KBO Gestionnaire local NRN - userid Utilisateur NRN - USERID Utilisateur NRN - USERID

48 FAMHP 27/03/2007 FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 48 Questions?