centralised procedure BrE
centralized procedure AmE

In actual fact, the centralised procedure will only focus on some illnesses.

The centralised procedure would also be positive for small and medium-sized enterprises.

Therefore, on the debate on the centralised procedure, I believe we must have flexibility.

For that reason, the Commission cannot accept amendments which reduce the scope of the centralised procedure.

Mr President, the centralised procedure is our preferred choice.

Firstly, on the extension of the scope of the centralised procedure.

If we do not have a centralised procedure by the time the ten new Member States join, there will be enormous inequality.

Mrs Grossetête perhaps needs to re-examine the whole question of the centralised procedure and access.

The common position did not follow the Commission and Parliament approach, but extended the current scope of the centralised procedure to some extent.

EudraPharm contains only details of products that were licensed using the Centralised procedure.

The second point I would like to make concerns the centralised procedure, where evaluation is carried out by the European Agency.

A credible application of the centralised procedure for marketing medicinal products cannot work without this sort of approach.

First, the need to reinforce the role of the European Medicines Evaluation Agency and the centralised procedure.

The new plan to impose use of the centralised procedure for products with new active substances will undermine competition between the authorisation procedures.

Authorisation: I am in favour of a centralised procedure with a degree of decentralisation to the Member States.

As a result, I am concerned by our rapporteur's persistence in asking, on several occasions, that working time be reduced by means of a centralised procedure.

As a result, a great many new and innovative medicinal products are subject to the centralised procedure and can be made available at an early stage to patients.

However, I should like to stress that careful evaluation of a centralised procedure would be done in the Commission report required under Article 30 of the directive.

The Commission is also convinced that extended scope for the centralised procedure for human and veterinary medicine would benefit European citizens and businesses alike.

The most significant concerns the scope of application of the directive and the Council’s refusal to make the centralised procedure obligatory immediately for all new active substances.

The centralised procedure via the EMEA in London is increasingly becoming the norm for an increasing number of medicinal products.

The Convention makes it possible to obtain patent protection in more than one state through a centralised procedure which is administered by the European Patent Office.

Another point of the agreement regards the development of an EMEA centralised procedure for the marketing authorisation of new medicinal products.

I am not going to repeat what has already been said by previous speakers, particularly on the subject of pharmacovigilance or the EMEA and the centralised procedure.

Therefore, the Commission is proposing to introduce the registration, by means of a centralised procedure, of new molecules, so as to ensure that everyone has access to the most innovative therapies.