Eksempler på brug af Simplified registration procedure på Engelsk og deres oversættelser til Dansk
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Secondly, the special, simplified registration procedure.
That is why the obligation of mutual recognition must go hand in hand with a more carefully defined simplified registration procedure.
Fourthly, the simplified registration procedure should be extended to veterinary homeopathic remedies for food-producing animals.
A first step we need to take is more widespread use of the simplified registration procedure.
Thirdly, simplified registration procedures need to be worked out in order to speed up the procedure for recognising homeopathic medicines.
Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure.
A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic medicinal products referred to in Article 14.
Only homeopathic veterinary medicinal produas which satisfy all of the following conditions may be subjea to a special, simplified registration procedure.
A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic veterinary medicinal products referred to in Article 17(1) and 2.
Only homeopathic veterinary medicinal products which satisfy all of the following conditions may be subject to authorization by means of a special, simplified registration procedure.
In our opinion, a simplified registration procedure should not be used either for medicines for human use or those for veterinary use, which can enter the food chain.
On the one hand there are no scientific arguments to justify this exclusion and, on the other hand,some Member States do use this specially simplified registration procedure for certain forms of administration.
It will also be necessary to extend the simplified registration procedure(Article 7) to include medicines administered parenterally when the injection phials comply with all the safety require ments laid down by the WHO for medicines to be administered by injection.
The criteria and rules of procedure provided for in Article 4(4), Article 17(1) and Articles 22 to 26, 112, 116 and125 shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy.
Let me say in conclusion that I have learned from numerous conversations with colleagues in the veterinary field that it is essential to organic farming that we no longer exclude homeopathic medicinal products for food-producing animals from the simplified registration procedure.
Article 9(2) says that homeopathic medicinal products not eligible for a special simplified registration procedure are to be evaluated and either approved or not on the basis of four other directives.
I think that a transparent and simplified registration procedure and a clear division of competences between the Member States and the Commission will provide more effective protection for consumers and producers, citizens of the Union and, most of all, for those who manufacture these products.
The criteria and rules of procedure provided for in Chapter 3, with the exception of Article 25,shall apply by analogy to the special, simplified registration procedure for homeopathic veterinary medicinal products referred to in paragraph 1, with the exception of the proof of therapeutic effect.
Article 7(1) also restricts the special, simplified registration procedure to preparations where the degree of dilution does not exceed one part per 10 000 of the mother tincture or a maximum of 1/100th of the smallest dose used in allopathy for active principles in medicinal products requiring a doctor's prescription.
While I believe it is very important that we try to cut out cowboys and people who operate in a completely unacceptable manner,this legislation was supposed to provide a simplified registration procedure that would allow the registration and marketing of certain traditional herbal medicines that have been on the market for a specific period of time.
Fourthly, until it is scientifically proven that homeopathic medicinal products for veterinary use do not involve risks to human health,we think the simplified registration procedure is inapplicable. Tinctures in particular must be subject to rigorous scientific tests to establish what degrees of dilution guarantee the safety of the food chain and protection from contaminated preparations.
Having regard to the particular characteristics of these homeopathic medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials,it is desirable to provide a special, simplified registration procedure for those homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the patient.
This means that we cannot accept amendments which introduce either non-defined technical concepts which aim at extending the registration procedure beyond requirements defining this simplified procedure, or which are contrary to the harmonisation sought.
Similarly, the product registration procedure must be simplified and made more accessible, making applications easier to assess by the Member States, limiting the role of the European Commission simply to checking the form.
The registration procedure for generic medicinal products needs to be simplified, so that it is possible to place generic medicinal products on the market directly upon expiry of the ten-year period following initial authorisation of the reference medicinal product.
At the Summit Meeting in March, the Member States also agreed to simplify registration procedures for new enterprises.
We therefore hope that a huge effort will be made to simplify registration procedures in India's bureaucratic system, which is very onerous, perhaps even more onerous than the European one, which says it all.
I would like to just say that the agreement includes a commitment to simplify the registration procedures, with a view to ensuring equal treatment for EU and Russian citizens, and I would like to remind you that the Schengen acquis also imposes a general obligation for aliens to register.
To accelerate and simplify that procedure, the time limit for the registration of the agreement should start to run on the actual day on which the quota statement is issued.
Should the assembly vote in favour of this compromise, the procedure of registration would be the so-called'simplified procedure.