- Wie wird eine Zulassung beantragt?
- Informationsveranstaltungen vor der Einreichung
Informationsveranstaltungen vor der Einreichung
Informationsveranstaltungen vor der Einreichung
Future applicants for authorisation may request a teleconference based information session (TIS) with ECHA to clarify regulatory and procedural issues related to the authorisation application process.
Purpose and scope
The teleconference based information sessions aim to give future applicants for authorisation the opportunity to ask case-specific questions regarding the regulatory and procedural aspects of the authorisation application process.
The purpose of the TIS is not to provide consulting services or advice on the preparation of applications or to pre-empt the evaluation of the conformity and the content of the application. The assessment of these elements of the application can only commence once ECHA is in receipt of the application for authorisation.
Requesting a TIS
TIS should be held the latest three months before the planned submission of the application for authorisation. One such session is envisaged per application.
Please send a request TIS at least one month before the meeting date in order for ECHA to make the necessary arrangements. The request for a TIS can be done together with the notification of intention to submit an application for authorisation.
After submitting the request, you will receive a TIS request number. Any subsequent communication between you and ECHA regarding the TIS needs to include a reference to this TIS request number.
Based on the request, ECHA will contact you to i) inform who will the staff member taking part in the TIS and ii) schedule the teleconference at a mutually agreed date and time. TIS are held via a tele/video conference. You need to book the teleconference (by telephone, or via Skype or WebEx) and send the log-in information to the ECHA.
Although efforts will be made to accommodate the preferences of the applicants, ECHA reserves the right to postpone or decline a request for a TIS, particularly in circumstances where the outlined timelines are not observed or due to limited availability of staff.
Documents for the session
Please prepare a document which describes i) the title of use applied for (see below), ii) a maximum of five specific and key questions that you wish to discuss and iii) the names and titles of the participants to the meeting as you know them at the time of making the request.
If you are a Small and medium-sized enterprise (SME) you can provide documentation to demonstrate this. During the TIS it is possible to clarify whether you would be eligible for an SME fee reduction. See SME verification pages.
For further details on "broad information on uses", read section 5.18.8 and 5.23 of the Data submission manual 22: How to prepare and submit an application for authorisation using IUCLID 5 See also - Publication of information on applications during the opinion-making process.
These documents should be submitted using the applicant's TIS request number via the following web form.
The TIS is envisaged to take about 45 minutes:
- Introductions and clarifications (about 10 min)
- ECHA’s answers to applicant's questions as outlined in the list of questions submitted to ECHA (about 30 minutes)
- Summary and conclusions (about 5 min)
No minutes are taken of the TIS.
ECHA will not be responsible for ensuring that the issues have been understood by the requester.
ECHA cannot be held liable for any negative consequences this has on the handling of the application and or any possible negative outcome of the AfA process.
ECHA has the right to use the applicants’ questions for the Q&A section of the ECHA website (no confidential information will be made public).
The teleconference based information session will not prejudice the outcome of the actual processing of applications for authorisation or the positions taken by the responsible ECHA committees on the issues discussed in their opinions.
ECHA does not accept any liability with regard to the contents of this web page. In order to correct any errors or inaccuracies that may appear in the text or if otherwise necessary, ECHA is entitled to modify or revise the information at any time.
Please note that the above mentioned information applies only in the context of the teleconference based information sessions. It does not create or alter any existing rights or obligations as set out in the Treaty on the Functioning of the European Union, the REACH or the Fee Regulations as amended. Nor does it alter the relevant Commission's interpretative notices or ECHA guidance documents.
Request a pre-submission information session no later than eights months before the planned submission of your application.
Send the request for a pre-submission information at least two months before the requested meeting date.
Upload and send the relevant documents at least one month prior to the pre-submission information session.
Your intended submission is 19 Nov - 3 Dec 2012:
- request a pre-submission information session by March 2012
- send relevant documents by April 2012
- hold the session in May 2012.