How to obtain EU and UK PSMF number

Written by Steen Ottosen

on 5 September 2021

EU PSMF number

For the EU the PSMF number is a unique code (MFL EVCODE) that is assigned by the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) system to a specific master file and master file location.

Applicants/MAH should request a PSMF number for their PSMF in advance of the relevant application introducing the PSMF (marketing authorisation, renewal or variation applications) in order to include the PSMF number in their application, in Module 1.8.1.

In order to apply for a PSMF number, applicants/MAH will need to be registered with EudraVigilance. Information on how to register with the EudraVigilance system and initiate the electronic submission of information on authorised medicinal products are available through the Eudravigiance webpage.

Following registration with Eudravigilance, the applicant/MAH should submit electronically in the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) the pharmacovigilance system master file location information using the agreed eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) format as referred to in chapter IV, Article 26, paragraph 1(a) of the Commission Implementing Regulation.

A unique code (MFL EVCODE) for the master file location will be assigned when the XEVPRM is processed in the XEVMPD. The assigned MFL EVCODE will be provided to the applicant/MAH as part of the XEVPRM Acknowledgement message for the MFL EVCODE request. This is also explained in GVP Module II on Pharmacovigilance system master file.

Note: In cases where a MAH hosts two different PSMFs at the same location, the MAH should obtain two separate EVCODEs from the XEVMPD that relate to two different PSMF location entries. These two PSMF locations will be identical but the comment field within the PSMF location of the XEVMPD should be used by the MAH to include an internal MAH reference to distinguish which PSMF is related the specific PSMF Location EVCODE (MFL EVCODE).

 

UK PSMF number

Now you also have to get a separate PSMF number in the UK if you want to place a product on the market in the UK. It is in principle the same concept as for EU but the process is more straight forward as it goes through MHRAs submissions portal and response comes as an email where the EMA system require the use of the XEVMPD system.

All PSMFs that cover UK authorized products should be registered with the MHRA. You should request a unique UK PSMF number from the MHRA for each pharmacovigilance system that you are operating for UK authorized products. Where the pharmacovigilance system is shared by several MAHs, a single request for a UK PSMF number should be submitted to the MHRA.

A UK PSMF number can be requested via the MHRA Submissions Portal. You should follow the online instructions for requesting a UK PSMF number and you should receive the number by email immediately upon completion of the form. The address from which the PSMF can be electronically accessed must be in the UK. Your UK PSMF number will be invalidated if the address provided is not in the UK. Any submissions to the MHRA using an invalidated UK PSMF number will not be accepted.

The UK PSMF number will be sent to the UK QPPV email address as well as the email address you nominated on the UK PSMF number request form. If you have not received a confirmation email within three hours of submitting the form, please contact submissions@mhra.gov.uk. Please do not re-submit the form as this will cause delays in processing your request.

You are encouraged not to request the UK PSMF number until you are either applying for a new UK marketing authorisation or notifying the MHRA of a change in the details of the QPPV for UK authorised products from the baseline information held by the MHRA.

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