You must submit information through our national portals for applications that you want to submit to the United Kingdom (for example, if you look at MHRA approved warehousing UK). You must continue to use the EU websites to submit regulatory submissions that were made through European processes (for example, CESP).
The following organizations will benefit from information on how to submit to the MHRA:
e-cigarette producers and brokers of medicinal products all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities for UK/GB licenses all medicines clinical trial sponsors wishing to make clinical trial submissions (Initial Applications, Substantial Amendments, End of Trial Notifications, and Developmental Safety Update Reports (DSURs) to the Agency
Please keep in mind that any current EudraVigilance Gateway users who want to utilize the new MHRA Gateway must first have access to MHRA Submissions. MHRA Submissions contains instructions for acquiring MHRA Gateway access.
The first firm administrator’s job responsibilities
- The original business administrator will be the first person in your organization to complete the registration process indicated below.
- When choosing this company’s first administrator, there are a number of criteria to consider.
- A company administrator may be in charge of making submissions or overseeing a team of people who will make submissions in smaller organizations. More than one business administrator is recommended for each organization.
- Regulatory affairs, pharmacovigilance units, clinical trials teams, and other teams or divisions within bigger organizations may make submissions through MHRA Submissions. You should carefully examine who is most suited to be the initial company administrator in your organization, as this person will be responsible for appointing additional company administrators and cascading duties down the line.
- It is advised that you have at least one other business administrator unless your organization is solely run by one individual.
- The term “administrator” and “user” are both used to refer to people who work for a corporation
- Other users can be added, edited, or disabled by a corporate administrator. Users’ inputs will be visible to a corporate administrator.
A business administrator can also have many firms registered under their account.
A user may only make submissions for the organization to which they are registered and cannot add additional users. If necessary, they can be added to a number of different legal bodies. Other users’ submissions will not be visible to a user.
The permissions of the first company administrator are the same as those of future company administrators. They will, however, be in charge of finishing the organization’s user access stages and establishing the company’s initial set of extra administrators and users.
You may add as many business administrators and users as you like. However, the way you set up access for your organization should be carefully considered. Because the business administrator is in charge of adding and removing users once an organization has been registered, you may want to think about who your company administrators are and how many there are.
Note that if you add more than 5 users at once, the changes will be done, but you will be sent to the homepage instead of the “user maintenance” page. Return to the “user maintenance” page to double-check that your new users have been added.
In pharmaceutical firms, setting up access for numerous legal entities
The User Reference Guide – Obtaining Access to MHRA Submissions explains how to accomplish so step by step.
If your firm has many legal entities, it’s a good idea to select a company administrator to register them.
This refers to the MHRA’s unique 5-digit business number for pharmaceutical firms.
In MHRA Submissions, MA Holders can create new Product Licensing (PL) numbers automatically. PLGB and PLNI are two of them. Because the 5 digit number is part of the PL Number, the firm must first establish this legal entity with a company administrator before generating the new PL Number. During the procedure, the firm administrator will be able to choose the right five-digit number from a drop-down option. If MA holders want a PL number particular to the United Kingdom or Northern Ireland, they must email PLNumberAllocation@mhra.gov.uk to seek one.
A drop-down company name/number must be specified for submission types such as initial applications and variants. If you use any of your registered numbers, there will be no effect on your submissions being delivered successfully via MHRA Submissions. The right Marketing Authorisation Holder information is stored within the program and is not reliant on the drop downs used. If anything changes in the future, we’ll try to make sure that programs don’t rely on this data.
The user access process was completed successfully.
What is the MHRA’s corporate number and where can you get it?
The MHRA provides each organization a unique number.
This number can be found on any communication you’ve received from the MHRA if your company has already submitted a submission.
This is the first five digits of your Product Licensing number if you’re working in the pharmaceutical sector.
This is the first five digits of a CTA number from a prior trial that your organization has filed. The 5 digit company number is your MHRA account number, and it may also be found on letter communication from MHRA e-cigarette manufacturers. This information can be found on your invoices – please note that this is not your EU submitter ID Brokers – the broker company number can be found on the Registration document issued by the MHRA Paediatric Investigation Plans (PiPs) submitters – if your organization already has marketing authorizations, this will be the first 5 digits of any of your product licenses. If this is your first time submitting to the MHRA, you’ll need to create a new firm (see below).
Consultants/agencies hired by a third party
External users (third-party consultants/consultancies) can be added as either a company administrator or an ordinary user to your organization. Before they can complete the user access process, they must have a 5-digit MHRA corporate number. Before they may be added to your organization, external users must complete this process.
This ensures that external users have the right amount of access, as well as allowing external users who work for numerous organizations to handle their contributions more effectively.