eServices

1. What are the advantages of using the eService "Marketing Authorisation & Lifecycle Management of Medicines"? Is it mandatory to use this eService?

 

The eService "Marketing Authorisation & Lifecycle Management of Medicines" facilitates communication between Applicants/MAHs and the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG)/AGES Austrian Medicines and Medical Devices Agency (AGES Medizinmarktaufsicht) in procedures for marketing authorisation of proprietary medicinal products and their lifecycle management. All procedures are listed centrally whereas deficiency letters are attributed to a certain procedure. Thus it is easy to submit responses.

 

Even though use of the eService "Marketing Authorisation & Lifecycle Management of Medicines" is not mandatory for now, communication as of 1 July 2013 will be primarily via this platform. Please note: From 31 January 2014 the email-addresses spc @ages .at and mrp-spc @ag es.at will be no longer available for the submission of product information texts. To submit product information texts please use the eService "Marketing Authorisation & Lifecycle Management of Medicines" instead. This new eService has, however, no impact on procedures according to the Austrian Medicinal Products Importation Act (Arzneiwareneinfuhrgesetz).

2. Is the eService "Marketing Authorisation & Lifecycle Management of Medicines" also intended for centralised procedures?

No.

3. Are administrative decisions (Bescheide) electronically delivered via the eService?

Are administrative decisions (Bescheide) electronically delivered via the eService?Administrative decisions are electronically delivered via accredited delivery services in line with the Delivery Act (Zustellgesetz). For further information please refer to the website of the Federal Chancellery of the Republic of Austria (Bundeskanzleramt) or the BASG-FAQ.

4. Which situations require documents to be provided via the new eService "Marketing Authorisation & Lifecycle Management of Medicines"?

The new eService "Marketing Authorisation & Lifecycle Management of Medicines" is intended for the submission of product information texts for AT and any related communication.

 

Submission of product information texts for Austria

The product information texts for Austria should be submitted either as working documents (WD) or - if Austria is the only member state concerned (national phase in MR-/DC-procedures, and national procedures in general) - via the eService "Marketing Authorisation & Lifecycle Management of Medicines".

 

In MR-/DC-procedures texts and documents are no longer requested to be submitted via email. From 31 January 2014, the email addresses
spc @ages .at and mrp-spc @ages .at will not be available anymore.

 

The eService can be used for proposed and final texts.

 

Please submit the dossiers/parts of dossiers as follows:

  • Submission of dossiers

For the submission of dossiers in national or MR-/DC-procedures please continue to use the Common European Submission Platform (CESP) or DVD/CDs.

  • Submission of responses to dossiers

For the submission of responses to dossiers please continue to use the Common European Submission Platform (CESP) or DVD/CDs.

5. How should I submit my product information texts to the AGES Austrian Medicines and Medical Devices Agency (AGES Medizinmarktaufsicht) during the procedure?

Please use the eService "Marketing Authorisation & Lifecycle Management of Medicines" for procedures that involve AT only (national phase in MR-/DC-procedures, and national procedures in general). If other member states are concerned as well (during MR-/DC-procedures), we recommend using the Common European Submission Platform (CESP), as the texts can be submitted to several member states at once.

6. Should I continue to use the email addresses mrp-spc@ages.at and spc@ages.at?

In MR-/DC-procedures, if using the eService "Marketing Authorisation & Lifecycle Management of Medicines", texts and documents are no longer requested to be submitted via email to spc @ages .at and mrp-spc @ages .at. From 31 January 2014, the email addresses spc @ages .at and mrp-spc @ages .at will not be available anymore. Please make sure that you register in time.

7. Do I have to check the portal actively for new documents or do I receive an email as soon as a new document is uploaded?

A notification eMail is sent when a procedure is started, when a new communications entry is creaed and when a procedure is closed. The receiver list can be edited by the organisation's administrator. For further information see:

8. Is the communication via the eService product-specific?

Yes, it is clearly indicated which products are concerned. Please note, however, that only pending procedures are listed.

9. Is it possible to assign product-specific user rights?

 

To assign user rights on a product level is not possible.

10. Do I have to upload PDFs only? Are MS word files (*.doc, *.docx) accepted as well?

All Microsoft Office File Formats as well as Portable Document Formats (PDFs) are accepted.

10a Uploading texts for national variations: which data types should be used?

Following a variation, texts should be uploaded as Word files, with changes highlighted accordingly. 

11. How can I provide a consultant with a restricted access to the eService "Marketing Authorisation & Lifecycle Management of Medicines"?

Two different scenarios can be distinguished:

  • Scenario A - Staff members of a consultant company should be provided with access to ALL pending procedures of an organisation.

Staff members of a consultant company should be included as staff members of the organisation in the “Administration of users and user rights” (Benutzer- und Rechteverwaltung).

 

  • Scenario B - Staff members of a consultant company should be provided with access to CERTAIN pending procedures ONLY.

The consultant company has to be stated in the Application Form as “Applicant” or “Person/company authorised for communication on behalf of the Applicant during the procedure/after authorisation”. Staff members of consultant companies should be assigned within the consultant company ONLY.

12. Does my company need a local contact in Austria in order to register for the eService "Marketing Authorisation & Lifecycle Management of Medicines"?

As you can register your company via Internet using the web browser, a local contact in Austria is not necessary. For further information please refer to FAG. Guidance notes (incl. translations of the German input fields in the registration form) are available.

 

After having registered successfully, the administrator of the organisation will receive a document containing the access data. The BASG/AGES Medizinmarktaufsicht allows you to appoint one administrator per organisation. The administrator can subsequently provide additional members of his organisation with access to all pending procedures of the organisation.

 

The new eService "Marketing Authorisation & Lifecycle Management of Medicines" is intended for the submission of product information texts for AT and any related communication in the national phase in MR-/DC-procedures, and in national procedures in general. For the submission of dossiers/parts of dossiers as well asresponses to dossiers the Common European Submission Platform (CESP) or DVD/CDs in both national and MR-/DC-procedures please continue to use.

den.

13. Does the BASG/AGES Medizinmarktaufsicht contact me via the eService"Marketing Authorisation & Lifecycle Management of Medicines" to discuss my product information texts for Austria?

The eService "Marketing Authorisation & Lifecycle Management of Medicines" is used for any communication during the national phase of MR-/DC-procedures as well as in national procedures.

14. Where can I find information regarding electronic application forms (eAFs)?

Further information regarding electronic application forms (eAFs) and can be found at:

http://www.basg.gv.at/en/medicines/electronic-application/elektronisches-antragsformblatt/

Created: 27.04.2011 | Page last modified: 04.10.2016

© Austrian Federal Office for Safety in Health Care
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