4 de março de 2019

UK NEWS: Making submissions to the MHRA in a no deal scenario

From: (MHRA) www.go.uk 

If the UK leaves the EU without a deal, submissions related to human medicines would need to be submitted directly to the MHRA.

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However, a responsible government must plan for every eventuality, including a no deal scenario.

The Agency is making preparations to ensure that in the event we leave the EU with no deal, you can continue to submit regulatory and notification information to the UK.

The following groups will need to ensure they follow the steps to gain access to MHRA Submissions, so they can make submissions from day one:
  • all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities
  • all medicines clinical trial sponsors wishing to submit clinical trial applications to the Agency
  • e-cigarette producers
  • brokers of medicinal products
Please note: all current Eudravigilance Gateway users who wish to gain access to the new MHRA Gateway will need to first gain access to MHRA Submissions. the steps for gaining MHRA Gateway access are contained within MHRA Submissions.

MHRA Submissions will not be used to send or receive ICSRs – details for the MHRA Gateway and ICSR Submissions will follow shortly.

Prior to day one, the only areas which will be enabled on the MHRA Submissions home page will be User Maintenance and PV Gateway Management.
Gaining Access to MHRA Submissions
Before getting started - guidance

Ensure that you have watched the videos and have referred to the user reference guides prior to clicking on the link in the Getting Started section.

Three short video demos are provided below which cover all aspects of the user access management process - these steps will enable your organisation to gain access and manage user permissions for using MHRA Submissions. You can access all three videos on Sharefile.
  • User registration – the end to end process for adding an initial company administrator
  • Add a new user – how to add an internal colleague as a user or company administrator
  • Add a new external user – how to add a third party consultant/consultancy as a user or company administrator
There are two user reference guides which contain step by step guidance on the processes:

User Reference Guide – Gaining Access to MHRA Submissions (PDF, 661KB, 11 pages)
User Reference Guide – Managing users on MHRA Submissions (PDF, 770KB, 12 pages)

The role of the initial company administrator
The first person in your organisation to complete the registration process outlined here will become the initial company administrator.
There are different factors to consider when selecting this initial company administrator.

For smaller organisations, a company administrator may also be responsible for making submissions or managing a team who will make submissions. It is recommended that each organisation has more than one company administrator.

For larger organisations, you may have different teams or departments who will be making submissions via MHRA Submissions, for example, regulatory affairs, pharmacovigilance units, clinical trials teams etc. You must carefully consider who is best placed in your organisation to be the initial company administrator as this person will be responsible for adding further company administrators and cascade responsibilities down through the organisation.

Unless the organisation is one person only, it is recommended that you have at least one other company administrator.

Getting started
To ensure you are able to make submissions to the MHRA from day one, you can begin the process for gaining access to MHRA Submissions.

This will allow an initial company administrator to gain access to MHRA Submissions and provide access to both colleagues and external consultants for your organisation.

Definition of a company administrator and user
A “company administrator” has the ability to add, edit and disable other users. A company administrator will also be able to see records of submissions made by users.

A “user” cannot add other users and can only make submissions for the organisation they are registered to. They can be added to multiple legal entities if required. A user will not see records of submissions made by other users.

The initial company administrator will have the same permissions as any subsequent company administrators. However, they will be responsible for completing the user access steps for the organisation and setting up the first set of additional company administrators and users.

There are no limits to the number of company administrators and users you can add. However, careful consideration should be given to how you set up access for your organisation. As the company administrator is responsible for adding and removing users once an organisation is registered, you may need to consider who and how may company administrators there are for your organisation.

Note: if adding more than 5 users at a time, the changes will be made but you will be redirected to the homepage rather than the “user maintenance” page. To confirm that your new users have been added, simply navigate back to the “user maintenance” page.

Setting up access for multiple legal entities in pharmaceutical companies
A unique email address is required when registering an organisation for the first time. It is recommended that if you have multiple legal entities under your organisation, you should appoint an appropriate company administrator to register for each of these entities.

For pharmaceutical companies, this relates to the unique 5 digit MHRA company number.

However, it is recognised that larger organisations may have a significant number of legal entities and setting up individual company administrators for each 5 digit number would be complex and time consuming. If an organisation chooses to only create a company administrator for one or few legal entities, there is one area that requires consideration.

Marketing Authorisation Holders will have the ability to automatically generate a new Product Licensing (PL) number in MHRA Submissions. As the 5 digit number is part of the PL Number, the organisation must ensure this legal entity is set up with a company administrator prior to performing the generation of the new PL Number. This will allow the company administrator to select the correct 5 digit number from a drop down menu during the process.

Submission types such as initial applications and variations require a drop down company name/number to be selected. There would be no impact on these submissions being successfully sent via MHRA Submissions, if you use any of your registered numbers. The correct Marketing Authorisation Holder information is contained within the application itself and is not dependent on the drop downs selected. For any future changes, we will aim to ensure there is no dependency on this data when submitting applications.

Successfully completing the user access process

Where to find the MHRA company number
The MHRA company number is a unique number the MHRA assigns to an organisation.
If your organisation has made a submission to the MHRA before, you will find this number on correspondences you have received from us.
  • Pharmaceutical industry - this is the first 5 digits of your Product Licensing number
  • Clinical trial applicants - this is the first 5 digits of the CTA number from a trial that your organisation has previously submitted. This can be also be found on letter correspondences from the MHRA
  • e-cigarette producers - the 5 digit company number is your MHRA account number. This information is available on your invoices - please note, this is not your EU submitter ID
  • Brokers - the broker company number is on the Registration document issued by the MHRA
  • Paediatric Investigation Plans (PiPs) submitters - if your organisation already holds marketing authorisations, this will be the first 5 digits of any of your product licenses. If you have never submitted to the MHRA before, you will need to be set up as a new company - see below
Third party consultants/consultancies
External users (third party consultants/consultancies) can be added to your organisation as either an additional company administrator or standard user. In order to do this, they must already have a 5 digit MHRA company number before completing the user access process. External users must complete this process before they can be added to your organisation.

This ensures you can provide the appropriate level of access to external users and will also allow external users who work on behalf of multiple organisations, to better manage their submissions.

Where to go for help
Please ensure you read all the information contained with the user reference guides, the video demos and on this page before contacting submissions@mhra.gov.uk.

Only the initial company administrator will need to complete the full user access process. If you attempt to complete the user access process and an initial company administrator already exists for your organisation, you will receive a message outlining this. If you are unaware of who your initial company administrator is, please ask within your company. They can then directly add you as an additional company administrator or user.

If you receive an email indicating that you have already been registered, this means that a company administrator has already set you up as an additional company administrator or user. Look for a confirmation email or contact your company administrator for further clarification.

If you have accidentally entered and selected an incorrect MHRA company number and realise afterwards, please contact submissions@mhra.gov.ukfor correction.

If you need to reset your password, click the “Can’t access your account?” link on the Sign-in screen and you will be guided through the appropriate steps. Please note this will be performed via Microsoft and not directly by the MHRA.