Applications for the transfer of a Manufacturer's/ Importer's Authorisation

A transfer takes place when the company or legal entity who holds a MIA transfers the authorisation to an unrelated company or legal entity. A transfer can also take place between related companies. This is when the companies share the same owners or parent company. If a common corporate body is formed as part of a merger or takeover, this is also treated as a related transfer.

Transfers of ownership only occur when there is a change to a company's legal entity. General company name changes are considered an administrative variation to an authorisation.

You can apply to transfer a MIA when:

• The company has stopped trading under the ownership or legal entity of the authorisation.
• The Companies Registration Office has granted an application to register the new ownership.
• The new legal site address is registered with the EMA's Organisation Management Service. You can find more information about the Organisation Management Service on the EMA's website.

Once the steps outlined under 'When can I apply to transfer my MIA?' are completed, you must complete the relevant application form:

• Application for transfer of an authorisation for manufacturing medicinal products for human use
• Application for transfer of an authorisation for manufacturing investigational medicinal products
• Application for transfer of a licence for manufacturing medicinal products for veterinary use

You must make sure that the application form is:

• Signed by both the current and future owner of the MIA,
• Witnessed,
• Accompanied with proof of payment. You can find more information on fees, fee applications, and payment of fees on our dedicated pages (human product fees page and veterinary products fees page)
• Submitted to the return address provided on the application form.