Local view for "http://purl.org/linkedpolitics/eu/plenary/2008-10-22-Speech-3-007"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20081022.2.3-007"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:spokenAs | |
| lpv:translated text |
". −
Mr President, Commissioner, ladies and gentlemen, allow me first of all to warmly congratulate the Council, the Commission and the shadow rapporteurs for their cooperation on this dossier of amendments regarding marketing authorisations for medicinal products.
I am aware, Mr President, that Mr Verheugen is to speak after me about the counterfeiting of medicinal products. We expect a great deal from his statement since it is important for this package, which includes the counterfeiting of medicinal products, to be presented to us. We have been looking forward to it for a long time. Counterfeiting is a crime which concerns public health. It is important for Mr Verheugen to tell us what stage he is at, as we are anxious to see this text. In any case, we offer him our full support.
It must be made possible for medicinal products, whatever procedure is applied in authorising their marketing, to be subject to the same evaluation, approval and administrative processing criteria in the event of changes being made to them. These changes, known as ‘variations’, relate, for example, to the manufacturing process, the introduction of a new therapeutic indication, updating of information leaflets, or administrative changes. These variations must be reported to the competent authorities by the holders of authorisations to market medicinal products.
However, the current way of managing variations is proving increasingly inefficient and is no longer satisfactory either for the authorities or for the pharmaceutical industry as a whole. There is too much red tape, adversely affecting patients, whose access to the best medicinal products is delayed.
The pharmaceutical industry devotes a growing part of its regulatory work to managing these variations. By way of example, in the case of a medium-sized company producing generic medicines and carrying a list of 400 products, the total number of variations submitted would exceed 4 000 per year. In the case of a large company, the number can reach 19 000. Changes to purely national marketing authorisations take place in accordance with provisions specific to each Member State, which are different from the European regulatory requirements.
Given that 80% of all human and veterinary medicinal products are authorised via national procedures, this revision will have a considerable impact on the pharmaceuticals market in the European Union. Any one change to products authorised under national procedures in different Member States is therefore treated in a number of different ways in terms of the dossier to be submitted and the evaluation procedure.
This situation has some undesirable repercussions: namely, it entails an unjustified additional administrative burden for the competent authorities and pharmaceutical businesses; logistical issues for the actual implementation of changes; and widely differing deadlines for introducing changes to the summary of characteristics of the product and the information leaflet for health care personnel and patients, with a knock-on effect on the overall working of the single market in pharmaceutical products. Lastly, it adversely affects patients, since the introduction of some changes that improve the effectiveness of a medicine may be delayed or, worse, never happen at all.
My report therefore has as its main objective the simplification and harmonisation of the rules relating to these variations of marketing authorisations for medicinal products. With this directive, the situation will be more straightforward, clearer and more flexible for all concerned. The rules relating to variations will be the same everywhere, whatever the type of authorisation, whether it is a national authorisation, mutual recognition procedure or centralised procedure for a medicinal product.
Simplifying these variations will mean they are subject to the same criteria with regard to the authorisation, administrative management and supervision of the changes made, whatever the legal procedure may have been whereby the medicinal products were licensed.
Moreover, I have proposed an additional amendment to the system where a change concerns a number of marketing authorisations. In this event, it must be made possible to submit a single application covering all these marketing authorisations."@en1
|
| lpv:videoURI |
Named graphs describing this resource:
The resource appears as object in 2 triples