European Parliament approves provisional reforms to drug variation procedures

The European Parliament has given a green light to a draft directive that will harmonise the current rules for changes in the authorisation of medicines across the EU.

The new rules will mean that variations of approval for drugs approved in the EU - including changes relating to production, packaging, patient information leaflet or manufacturer's address - will be treated in the same way across the 27 EU member states, which have already given the go-ahead to the deal.

The proposal will allow the Commission to extend the scope of existing regulations on variations to ensure that all medicinal products marketed in the EU - including those authorised solely at a national level - are subject to the same criteria for the approval and administrative handling of changes, regardless of the procedure under which those medicines have been authorised.

At a debate at the plenary session of the European Parliament in Strasbourg, European Commissioner for Enterprise and Industry Gunter Verheugen pointed out that the current legislation carried a big burden on taxpayers in terms of cost and regulators' time. "We can't accept this. It's necessary to further develop medicines all the time but the costs involved in the registration procedure are too high," he said.

In the joint statement, EFPIA, EVM (European Vaccine Manufacturers) and EBE (European Biopharmaceutical Enterprises) said: "This new legislation is expected to contribute to the "Better Regulation" policy agenda, offering a means to reduce the bureaucratic burden without compromising public health while fostering innovations."

Beata Stepniewska, director of regulatory affairs at the European Generics Medicines Association (EGA) called for clarification over whether certain older products would be exempt from the new rules. She said the amendment "leaves the door open" for variations to products approved before January 1998 to be approved by the existing national system.

This would have a "very limited" impact on the general EU harmonisation of the variations procedures and would be used by "very few member states", she said.

"The EGA has been always in favour of common criteria for assessing and approving changes to all medicinal products across the EU for all types of procedures in all Member States and is also in favour of the legal reinforcement of the approval process proposed by the European Commission," she added.