Updated MHRA Guidance on the PSMF for products authorized in UK

                                                                  MHRA

From 1 January 2021, for medicines authorized in Great Britain, Marketing Authorization Holder (MAH) holders must maintain PSMF that described the pharmacovigilance system for UK authorized products.

• The PSMF must describe the global pharmacovigilance system and reflect the global availability of safety information for UK authorized products.
• MAH need to make sure that every pharmacovigilance system covering UK authorized products has been assigned a unique PSMF number by the MHRA.
• A UK PSMF number can be requested via the MHRA Submissions Portal from 1 January 2021.
• A UK PSMF number can be requested via the MHRASubmissions Portal from 1 January 2021.
• Single request for UK PSMF number should be submitted to MHRA, where the pharmacovigilance system is shared by several MAHs.

• For MAs that are specific to Great Britain: PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.

For MAs that are specific to Great Britain, legal requirements concerning the format and content of the PSMF are outlined in Part 1 of Schedule 12A of HMR, which mirrors Chapter I of CIR. 

• For MAs that cover the whole of the UK or are specific to Northern Ireland: the PSMF must be located either at the site in the European Union, where the main pharmacovigilance activities are performed or at the site where the QPPV operates, in accordance with Article 7(1) of the CIR. The PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.

For MAs that cover the whole of the UK or are specific to Northern Ireland, the legal requirements concerning the format and content of the PSMF that are outlined in Chapter I of CIR will remain unchanged.

As the legal requirements concerning PSMF format and content are identical for MAs that cover the whole of the UK and Northern Ireland, and those that are specific to Great Britain, a single PSMF can be used for all UK authorized products.

Source💬: MHRA- www.gov.uk 

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MHRA Submission: The Role of Initial Company Administrator

The UK has left the EU, and the transition period after Brexit comes to an end this year. From 1 January 2021, for medicines authorized in Great Britain, Marketing Authorization Holder (MAH), will be required to submit pharmacovigilance data to the MHRA, according to GB requirements.

MHRA will require following submissions via the new MHRA Gateway or/ICSR Submissions portal.

• All pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities
• 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
• E-cigarette producers
• Brokers of medicinal products·

The first person in an organization who completes the registration process will become the initial company administrator.

Factors to be considered for initial company administrator-

1. 👉Smaller Organizations- a company administrator may also be responsible for making submissions or managing a team who will make submissions. It is recommended that each organization has more than one company administrator.

2. 👉Larger Organizations – may have different teams or departments who will be doing submission via MHRA Submission Portal like regulatory affairs, pharmacovigilance units, clinical trials teams etc. MAH need to carefully consider who is best in organizations for initial company administrator. This person will be responsible for adding further company administrators.

 A difference between Company Administrator and User

 👮A company Administrator: -

• 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 company administrator also has the ability to register multiple companies under their account.
• 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 organization and setting up the first set of additional company administrators and users.
• There are no limits to the number of company administrators

 👷A User:

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

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.

Source: MHRA- www. gov. uk

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