If a change of qualified person for pharmacovigilance/responsible person for EudraVigilance (QPPV/RP), named person or legal representative within the organisation occurs, you need to notify EMA.
The registration of a new EU QPPV or the change of EU QPPV is described in an EMA document called “New Organization First User QPPV/RP or Change of EU QPPV/RP” from 29 April 2021 (note there is an outdated version from 2017 as well). More details can be found in the EU Registration Manual of 29 April 2021 but I will suggest to go through the document from 2017 first as that includes all the key steps in a brief document.
The document describes two scenarios:
- there is still an EU QPPV or RP registered for the organization
- the EU QPPV or RP role is new and there is no prior assignment as EU QPPV or RP
There is an EU QPPV or RP and the person assigned is changing
You need to register yourself as normal user via EMA Account Management Portal and request standard user or additional QPPV as agreed by the current QPPV/RP, who will validate your access. See Registration manual
1. Log in to EMA Account Management portal > manage access> remove access and ensure you remove all the roles you have for the profile you wish to become RP/QPPV for. See Registration manual
2. The leaving QPPV/RP will need to remove his/her role as QPPV/RP via the EMA Account Management portal. Then obtain a Request ID that needs to be included in the cover letter mentioned in #3 for the new QPPV/RP.
3. The new QPPV/RP will need to raise a ticket via EV Registration Service Desk, requesting the validation of your new role as QPPV/RP, stating your organisation ID and name, attaching the following documents:
A cover letter should be sent from the headquarters level of the organisation on a headed paper.
-
- The cover letter should be signed by the new QPPV/RP or by a person in a position above that at headquarters level (i.e. director of the organisation or similar), or by the legal representative for Commercial and Non-Commercial Sponsors
- The cover letter should state the name and position of the previous QPPV/RP and the name, position and contact details of the new QPPV/RP as well as confirm that the QPPV resides within the EU/EEA.
- A copy of the ID card or driver’s license or passport.
- EMA require that the full name and signature are visible. You may black out any other information contained on the ID document.
- This information will be used to verify the identity of the registering person and will be treated as confidential and will not be published or included in any user list
- User declaration form for QPPV, RP , including the type and name of the organisation, user’s details and dated and signed by the user (download here)
- Declaration from the EU QPPV/RP that that the organisation has a suitably trained person for submission of ICSRs and XEVPRMs.This declaration can be included in the cover letter or on the body of the email submitted via the EV Registration Service Desk. Submitting copies of ICSR and XEVMPD certificates is not necessary when changing the QPPV/RP. Please note, training certificates do not have to be in the name of the new QPPV/RP, but in the name of any active user of the profile who has completed the above courses and is related to the respective organisation.
Sponsors should additionally provide the following documents:
- Form A signed by the sponsor’s legal representative person appointing the new responsible person for clinical trials, including the name and the contact details of this person ( (download Form A here). The legal representative person and responsible person address should be for the respective organisations they work for.
- Form B – For Sponsors based outside EEA only Form B should be also sent, signed by someone from the sponsor appointing the sponsor’s legal representative person in the EEA, including the name and the contact details of this person (download Form B here). The legal representative person address should be for the organisation the legal representative works for. If Form B has been previously submitted for the previous RP registration and the legal representative of the sponsor is unchanged it does not need to be completed again.
- EMA will confirm the removal of the previous QPPV/RP and then the new QPPV/RP will need to request the role of QPPV/RP via the EMA Account Management portal.
Note that if you need to register as Responsible Person you will need to when you search for only the word “responsible” then the list will show “EV Human CS NCS Responsible”which is the one you need to pick in that case.The system will then ask for additional information and you have to search for the organization you are going to be the RP for – check that it is the right organization which is the one that hold the trial authorization.
Note that the system will provide an request id – write that down and send it as response to the service request note from EMA - EMA will validate your QPPV/RP role once the provided documents are checked. You will receive an email notification that your role has been approved
There is no QPPV/RP in your organization
1. Register yourself in EMA Account Management portal and request EU QPPV or Responsible Person role. For further details, please see EV Registration manual.
2. Provide the following supporting documents:
- A cover letter should be sent from the headquarters level of the organisation on a letter headed paper.
- The cover letter should be signed by the new QPPV/RP or by a person in a position above that at headquarters level (i.e. director of the organisation or similar), or by the legal representative for Commercial and Non-Commercial Sponsors.
- The cover letter should state the name, position and contact details of the new QPPV/RP as well as confirm that the QPPV resides within the EU/EEA.
- eMail confirmation from the OMS Data Stewards acknowledging the successful creation of the new organisation.
- A copy of the ID card or driver’s license or passport.
- EMA require that the full name and signature are visible. You may black out any other information contained on the ID document.
- This information will be used to verify the identity of the registering person and will be treated as confidential and will not be published or included in any user list.
- The user declaration form for QPPV/RP, including the type and name of the organisation and, user’s details. The form should be dated and signed by the user (download here).
- For MAHs only – A copy of the trade register for pharmaceutical companies.
- For MAHs only – Proof of an EEA marketing authorisation or application for an EEA marketing authorisation for at least one product.
- For Sponsors only – Form A – signed by the sponsor’s legal representative person appointing the new responsible person for clinical trials, including the name and the contact details of this person (download Form A here ). The legal representative person and responsible person address should be for the respective organisations they work for.
- For Sponsors based outside EEA only – Form B – signed by someone from the sponsor appointing the sponsor’s legal representative person in EEA, including the name and the contact details of this person (download Form B here ). The legal representative person address should be for the organisation the legal representative works for.
- For Sponsors only – A EudraCT number for a study the sponsor is conducting.
- A copy of the notification of successful completion of the EudraVigilance ICSR and XEVMPD knowledge evaluation for at least one user to access the production environment, as applicable. Please note: training certificates do not have to be in the name of the new QPPV/RP, but in the name of any active user of the profile who has completed the above courses and is related to the respective organisation.
EMA will validate your QPPV/RP role once the provided documents are checked. You will receive an email notification that your role has been approved.
The European Medicines Agency will process this information to verify the identity of the registering person and it will be handled in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data. The name of the QPPV/RP and contact details are accessible to the registered organisation in the restricted area of the EudraVigilance and are not made public. For more information, please click here
