Line extension application

A line extension is a marketing authorisation in the name of the same marketing authorisation holder, for example if the pharmaceutical form and/or strength of the product differs from one or more other veterinary medicinal products for which this marketing authorisation holder already has a marketing authorisation.

A line extension is an important extension of an existing marketing authorisation, which is why a separate application for a marketing authorisation is needed for a line extension, pursuant to article 12 or 13 of Directive 2001/82/EC. The holder of this marketing authorisation is the same as for the other products in the ‘line’.

In fact, a new product is being added to the product selection of the marketing authorisation holder. In some cases, as a marketing authorisation holder, you can also choose to add the extension within the framework of the existing REG NL number, in which case the existing marketing authorisation is then modified, i.e. extended.

A ‘line extension’ is defined as: All changes that fundamentally modify a registration and are listed in Appendix ll of Regulation (EC) No. 1234/2008.