FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS Federal

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

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

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

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS Belgian e-submission Structure (Be. St) 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 e. CTD’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 FAMHP 27/03/2007 4

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

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

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS Be. St 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 e. CTD-guidelines This document has an extension that is not allowed in an e. CTD-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 FAMHP 27/03/2007 7

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS Be. St 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/ FAMHP 27/03/2007 8

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

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

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

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

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS Reminder. . . folder structure • You are familiar with the e-CTD folder structure: • 0000 • m 1 • eu • • • m 2 • m 3 • . . . FAMHP 27/03/2007 10 -cover 11 -toc 12 -form 13 -pi. . . 13

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

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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) • ICH E-CTD specifications for modules 2 – 5 (v 3. 2, Feb 2004) • See ICH guidelines on CTD (www. ich. org) FAMHP 27/03/2007 15

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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 FAMHP 27/03/2007 16

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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” FAMHP 27/03/2007 17

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS File naming conventions • Always use lower case ! • Conclusion: a file name is always of the type: cc-fixedcomponent-var. ext e. g. be-cover-xxtablets 10 mg. pdf common-spc-xxtablets 10 mg. doc FAMHP 27/03/2007 18

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS “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 FAMHP 27/03/2007 19

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS “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 Wonderpilstructure 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 FAMHP 27/03/2007 20

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

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

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

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

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

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

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

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

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

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

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

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

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

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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. FAMHP 27/03/2007 34

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

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS Portal Applications - e. Me. DI electronic Medicinal Dossier Interface (e. Me. DI) 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. FAMHP 27/03/2007 36

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

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

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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. FAMHP 27/03/2007 39

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS "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). FAMHP 27/03/2007 40

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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). FAMHP 27/03/2007 41

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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 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. FAMHP 27/03/2007 42

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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, …). FAMHP 27/03/2007 43

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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. FAMHP 27/03/2007 44

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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. FAMHP 27/03/2007 45

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

FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS 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 FAMHP 27/03/2007 47

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