Changing the name of a company for authorisations held under Medicines Regulations

Companies will be aware variations are required to amend authorisation details held by the MHRA when the company holding an authorisation under Medicines Regulations intends to change its name. This also applies if any company listed on an authorisation in some capacity (for example, a manufacturer) changes its name. Therefore, it is very important that companies promptly communicate any changes of company names to their business partners so these changes can be appropriately actioned by the authorisation holder.

Variations
When such a change occurs the company holding the authorisation must vary each individual authorisation affected. In the case of a change to the name of a company holding one or more authorisations, the MHRA needs to make a change, not only to the authorisation details but, also to the indexing of all documentation related to that company name. This is due to the way in which we hold the information, so this change has to be made simultaneously to all documentation for applications and authorisations.


Facilitating the change
To facilitate this change and allow the rapid implementation of the new name, companies wishing to change their name should: 

Give advance notice of the intended change. An e-mail must be sent to our Regulatory Information Service (Company.namechange@mhra.gsi.gov.uk ), with a list of their own authorisations affected, one month in advance of submitting the necessary variations. This will enable us to confirm the number, status and types of these authorisations. The list should be presented as a spreadsheet.

In cases of a change to the name of the authorisation holder, we will agree with you a date for submission of the required variations. Some actions on other changes may need to be put on hold.

This procedure applies to holders of the following authorisation and documentation types:

  • Marketing Authorisations
  • Master Files
  • Manufacturer's Licences
  • Wholesale Dealer's Licences

In cases of a change to the name of a company that may be named on authorisations held by third parties (for example as a distributor, importer or batch release site) then the company changing their name must immediately advise the actual holders of these authorisations when the name change has been effected. The relevant authorisation holder will then be able to make the necessary changes to their own authorisations and documents as part of an appropriately supported variation application. 

 For Clinical Trial Authorisations, the sponsor should consider whether the change to the company name would require the submission of a substantial amendment. Changes to information held in the Annex 1 “Initial” application form would be considered to require the submission of a substantial amendment.

The name changes will be published on our website as soon as the variations have been determined. A rolling list, updated on a monthly basis, will be published on the ‘Medicines regulatory news’ page of our website:
› Medicines regulatory news 

This advice applies only when an amendment is made to the name of the company. If the legal entity holding the authorisations is to change then new authorisations need to be issued and advice on this Change of Ownership procedure can be found on in the Change of ownership section:
› Change of ownership applications

 


Page last modified: 05 August 2008