On 10 June the Commission's regular committee passed and published a revised
draft of the variations regulation, entitled COMMISSION REGULATION (EC)
concerning the examination of variations to the terms of marketing
authorisations for medicinal products for human use and veterinary medicinal
products. It is available at
An important goal of the regulation is to further decrease the overall number of
variations procedures. It is supposed to enable the competent authorities to
concentrate on those changes that will in fact impact quality, safety or
efficacy. For certain, less severe changes it is planned to introduce a system
with annual reports - similar to the system already established in the US. These
changes will not have to be approved in advance and should be notified within a
12 months period after their implementation. This would also mean a tremendous
relief for the pharmaceutical industry, especially with regard to changes
concerning the continuous improvement of manufacturing processes.
In addition there are a number of new requirements concerning the classification
of changes. It is also supposed to be possible to propose a reference authority
for changes to multiple authorisations. Under certain conditions changes can be
grouped and submitted to the authorities in a single notice.
The European Parliament and the Council have three months now to review the
draft before it can finally be passed. One year after becoming effective the new
regulation will have to be implemented.
On behalf of the European Compliance Academy (ECA)