Transfer of a Manufacturing Authorisation

Transfer of ownership of an authorisation/licence for manufacturing or wholesaling medicinal products for human or veterinary use

A change of ownership is when a company wishes to transfer an authorisation from one company to another that is one legal entity to another. A transfer of ownership can also take place amongst related companies i.e. companies that share the same owners or parent company. Where a common corporate body is formed as part of a merger or takeover, this is also treated as a related transferred.

Application for transfer of an authorisation for manufacturing medicinal products for human use must be sent to the HPRA once the company has ceased trading under the business name and an application to register the new ownership has been granted by the Companies Registration Office, for further information click here.  

Please note, transfers of ownership only occur when there is a change to a company’s legal entity. General company name changes are considered as administrative variations to an authorisation. 

 

To submit a Transfer Application please complete the applicable form below:

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