The requirements for Change of Ownership submissions have changed. Applicants will now be required to declare the Marketing Status of the product when the transfer of licence has been applied for. An application form can be downloaded from the change of ownership requirements section. Please submit the completed form with your Change of Ownership application.
The purpose of the declaration is in line with Marketing Authorisation Holder’s obligations under Article 23a of Directive 2001/83/EC, to notify the MHRA of the marketing status of their products. It is important that companies keep this record up to date as a requirement of the legislation, so the MHRA holds accurate records in relation to product availability and also to avoid further action in relation to Article 24(4-6) the ‘Sunset Clause’.
Any individuals involved in the preparation of a Change of Ownership submission must complete all of the Change of Ownership form including Annex 1 for applications submitted on or after 26 August 2013.
For more information visit the change of ownership applications and Sunset Clause sections.