Exemple de utilizare a Proposed wording în Engleză și traducerile lor în Română
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Fearing Roosevelt's proposed wording.
The proposed wording should be revised.
The MAH further agreed to the proposed wording by the CHMP as follows.
The proposed wording provides a wider coverage of issues than at EU level.
All differences were accordingly justified and the proposed wording in the SPC is acceptable.
The effect of the proposed wording would therefore be to lower the level of legal certainty aimed at by the Regulation.
Amendments 18 and38 aim to clarify this provision, however the proposed wording is not compatible with Regulation(EC) No 1830/2003.
The proposed wording of Article 90 will give significantly more power to the Commission at the expense of the European Parliament.
Other amendments which were not acceptable or not acceptable in the proposed wording for the Commission have not been included in the common position.
The Commission considers that the proposed wording is somewhat too restrictive, but accepts the underlying need to amend this provision, in order to clarify that it refers only to employees who are sufficiently autonomous to enjoy genuine control over their own working hours.
Therefore the CHMP agreed with the proposal but asked the MAH to justify the proposed wording regarding 5-FU refractory patients.
The CHMP assessed the proposed wording provided by the MAH, and particular attention was given to the following issues.
The remaining amendments of the European Parliament which were not acceptable or not acceptable in the proposed wording for the Commission have not been included in the common position.
The EESC demands that the proposed wording in the CPR in article 5 by the EP"cooperate with the partners" must be substituted by"involve the partners".
In view of the dataprovided on efficacy and safety, the benefit/ risk of the proposed extended indication“ mild to moderate pelvic inflammatory disease” was therefore considered to be positive by the CHMP as the initially proposed wording was adequately revised to reflect the current knowledge.
If these items are adopted in the proposed wording, they could become a serious obstacle to further progress in the process of a peaceful resolution to the conflict in Nagorno-Karabakh.
The CHMP noted the pivotal study JHQJ was powered to detect differences in TtDP in overall survival and that the pivotal study for the ovarian cancer had a specific population consisting of platinum sensitive patients with avery poor prognosis and the CHMP was of the opinion that the proposed wording was in accordance with the submitted study for the marketing authorisation in this indication.
The Commission however accepts the proposed wording'on or with' the bill which gives more flexibility to distributors on the way they will comply with Article 5(3).
The Committee believes that, in the context of this proposal,whose aim is to increase the safety of dangerous goods, the proposed wording means that Member States would not be able to ban the transport of dangerous goods on their territory for safety reasons, which would seem to be rather illogical.
In particular, the proposed wording for Section 4.2 at the end of CMDh procedure was amended to reflect that in severe asthmatics, a 12 week study provided by the applicant/ MAH has shown that a dose of 640µg/ d(given 320µg/ d twice daily) demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function.
For these reasons,the Court ruled that, in the proposed wording, the draft law on the revision of the Constitution cannot be submitted for examination before the Parliament.
The EESC does not agree with the proposed wording of Art.15(11) that"Member States may authorise or register collective agreements permitting exceptions to the required hours of rest[of seafarers]".
He then asked Bureau members to clarify their position on the proposed wording of Rule 10, pointing out that the three groups had reached an agreement on this text within the Budget Group and the Rules of Procedure Panel.
In general, the CHMP considered 13 the proposed wording to be adequate, but implemented a number of revisions, including sections on impaired bone-marrow function, combination with carboplatin and cisplatin, live attenuated vaccines and Pharmacovigilance reports on cardiovascular events and viral hepatitis reactivation.
The CHMP was also of the opinion that the proposed wording of the SPC gives enough flexibility to the treating physician to start with the dose of 25 mg or higher.
Since the issue of clinical utilitywas satisfactorily addressed and the MAH agreed to the proposed wording, the CHMP is of the opinion that the data provided allow the conclusion that, on basis of the pivotal clinical studies comparing Gadovist-enhanced with Magnevist-enhanced MRI, diagnostic efficacy of Gadovist for the classification of focal liver or renal lesions as benign or malignant, as well as clinical safety of Gadovist has been adequately established.
In the next room,artist Eva Maria Schartmüller proposes words inspired by the observation of the loss of social identity through the loss of hair following chemotherapy treatments.
The CHMP adopted the proposed revised wording.
The Commission can accept the new wording proposed in the common position.
The CHMP assessed the SPC wording proposed by the MAH and the submitted rationales for the proposal.