Voluntary Harmonisation Procedure for Clinical Trials of Medicinal Products (VHP)
The aim of the VHP is the joint assessment of multinational clinical trials by all concerned member states followed by an accelerated national authorization procedure. For further information on the process please refer to the VHP guidance document below.
Points to be considered for the national part of the VHP in Austria
- The cover letter should contain a clearly visible statement that the submitted clinical trial was part of a VHP with Austrian participation and a reference to the VHP number
- In the cover letter the applicant should confirm that the submitted documents are identical to those assessed during the VHP and that no other modifications have been made (administrative modifications are acceptable)
- In case of conditional approval the applicant should describe in the cover letter how the conditions were fulfilled and include a reference to the applicable sections in the dossier (e.g. the protocol or IMPD section/page)
National approval of VHP
In Austria clinical trials of medicinal product (with the exception of ATMPs) are authorized via “silent approval” i.e. when no concerns are raised within 35 days after confirmation of formal completeness (Vollständigkeitsbestätigung) of the application. No written approval is foreseen.
For VHPs formal completeness will be evaluated and confirmed to the applicant in the same way as for regular clinical trials (please refer to the guidance for CTA submission on our website). The confirmation letter is identical for all clinical trials and therefore contains the reference to the 35-day-period. However, accelerated approval as agreed for VHP will be performed.
Attention: The submission to the concerned Austrian Lead Ethics committees is to occur prior or in parallel to the submission to the BASG also for a VHP. Otherwise a confirmation of formal completeness is not possible.
In a next step the assessor needs to check that the dossier is identical to the one approved in the VHP, all conditions have been fulfilled and no other modifications have been made. Then the application will be transferred to the Austrian Federal Office for Safety in Health Care (BASG) for formal approval.
The transfer to the BASG will take place within ten days (normally one working day) after confirmation of formal completeness and is notified to the applicant via mail to the address provided in section C.1.4.6 of the application form. The mail will also include the link to the BASG website, the reference information to identify the trial (Geschäftszahl) and the contact information of the national VHP coordinator.
The clinical trial can then be initiated upon publication of approval on the BASG website and availability of a positive opinion by an Austrian Leading Ethics Committee.
The following documents should be archived to document approval by the BASG:
- confirmation of formal completeness (Vollständigkeitsbestätigung)
- confirmation of transfer to the BASG (E-Mail „EudraCT-Nr. XXX (VHPXXX): Transfer to BASG“)
- screenshot of the BASG website showing reference number, authorization and authorization date of the clinical trial
- for substantial amendments via the VHP the national process is the same except that there is no confirmation of formal completeness. Instead the confirmation of receipt (automated mail to the address provided in section C.1.4.6 of the application form) should be filed.
Should the VHP guidance document or the information on this page not answer your questions, please contact firstname.lastname@example.org.
Dr. Stefan Strasser
Created: 18.06.2009 | Page last modified: 01.12.2014