Applications for a variation to a Manufacturer's/ Importer's Authorisation (MIA)

You must apply for a variation to a Manufacturer's/ Importer's Authorisation (MIA) if there are any proposed changes to the manufacturing site that holds an authorisation. There are two types of variations:

• An administrative variation is considered a minor change to the MIA.
• A technical variation is considered a major change to the MIA. A GMP inspection may be required as part of the assessment for this type of variation.