Jiří Maštálka, on behalf of the GUE/NGL Group. – (CS) I would first of all like to express my thanks to the rapporteur for producing such an extensive piece of work in this report, and especially for the successful efforts, or should that be the potentially successful efforts, in negotiating a compromise with the Council and with the Commission. I would also like to thank the Commission for directing its efforts towards unifying the administration in the area of certifying drugs and also to thank it for the fact that these efforts should result in higher levels of safety for patients.

It is clearly essential to harmonise legislation at a European level in the area of registering drugs. We need a unified set of administrative rules for all drugs on the internal market, in order that we can prevent negative impacts on human health. I therefore warmly welcome the aim of this proposal to ensure that all drugs on the market are subject to the same criteria, including those drugs that have been approved purely at a national level. I would like to consider the question of purely national registration in more detail. Even though I was a supporter of unified criteria with no exceptions, I believe that the text of proposed amendment number 36, allowing national regulations to continue in use for drugs that have been registered at a purely national level and approved prior to 1 January 1998, should not be an obstacle to harmonisation at a European level as it is so well thought-out and provides sufficient guarantees, such as the requirement to inform the Commission of decisions to continue with the application of national regulations or the requirement for transfer to European regulations where a drug has already been registered in another Member State.

Regarding the implementation of a single application covering one or more identical changes, I feel that it would bring a certain measure of relief to the large pharmaceutical companies, which is surely a good thing. I am not quite so sure, however, that the positive effect will be to reduce the administrative burden in the individual Member States. That is a negative effect which we may be able to eliminate in the future. Despite the minor reservations that I have expressed here, I consider the text which has emerged from the debate to be a positive step in the area of registering drugs and, bearing in mind how difficult it was to achieve this compromise, I recommend it as shadow rapporteur to colleagues from my political group for approval. Apart from anything else, there is also the practical reason that if this directive is not passed at the first reading this year, it will be up to the Czech presidency to find a solution to these very difficult questions. Therefore, we have an opportunity now.