European Commission to simplify marketing authorisation variations

The European Commission is to launch a public consultation with the aim of simplifying the procedure for notifying variations to marketing authorisations.

While there is no specific date for the proposed revision of the 'variations' regulations, this should take place at the end of 2007 or the beginning of 2008, according to Commission administrator Nicolas Rossignol.

A public consultation open to all concerned parties is planned for 2007. The aim is to make the 'variations' procedure, which was last revised in 2003, simpler, more effective and homogeneous throughout Europe.

Currently companies must apply to regulatory authorities every time they want to modify an element of a marketing authorisation, whether this is a modification of the production process, a change in packaging or even a simple change of address.

The industry considers this system to be very time and resource-consuming: a European Generic medicines Association (EGA) survey found that a large generics manufacturer makes an average of 19,000 variations annually, while an average-sized generics manufacturer makes about 4,000. The current system also generates costs for the industry, as notifying variations means paying fees.

The variations regulations apply to Commission-issued marketing authorisations and to those granted by national agencies using either decentralised or mutual recognition procedure.

In a working paper from last October the Commission also proposes to include 'purely national' marketing authorisations under revised EU legislation on variations, for reasons of member state harmonisation. This working document also suggests that the notion of 'design space' be introduced to limit the number of variation applications and make the system more flexible.

Under current legislation, every marketing authorisation modification, even the most minor ones, included in an exhaustive list, must be registered either as a variation or as a line extension. The Commission document suggests that all modifications within this 'design space', whose perimeter has not yet been defined, will no longer require a formal variations application, but will instead be notified annually by the company.

Only changes outside of the 'design space' will continue to require a variation application.

Concerning 'minor' type 1A variations, the Commission suggests replacing the current 'tell and do' system, whereby companies must notify the authorities before they can implement the variation, by a 'do and tell' system under which the authorisation holder will be able to carry out the change and notify the authorities later.

These 'do and tell' notifications could be communicated to the authorities by companies in an annual report, the document suggests.

Variations would thus be divided into two categories: modifications that need advance notification for reasons linked to health risks; and those that do not need such authorisation - for example, purely administrative modifications, which will follow the 'do and tell' procedure.