Примери за използване на Sufficient to demonstrate на Английски и техните преводи на Български
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It is also sufficient to demonstrate that this duty is of tremendous proportion.
The CHMP considered that the data from these trials may not be sufficient to demonstrate the claimed benefit.
This was considered sufficient to demonstrate that the benefits of Zarzio are comparable to those of the reference medicine.
The CHMP is of the opinion that the documentation submitted by the MAH is not sufficient to demonstrate the efficacy and safety of tolperisone.
This was considered sufficient to demonstrate that the benefits of Valtropin are comparable to those of the reference medicine.
AG4K Documentation of the entity's strategy need not be extensive butshould be sufficient to demonstrate compliance with paragraph 9(b)(ii).
The data from the clinical study was not sufficient to demonstrate the benefit of Opsiria, particularly in European patients.
The grounds for the referral were the concerns of Sweden that the data on Kantos Master submitted in the application were not sufficient to demonstrate its effectiveness for MART.
Such a general statement does not appear sufficient to demonstrate the necessity of the measure proposed.
Details of the measures in place to minimise and handle risks including safeguards, data security, and other measures andmechanisms to ensure the protection of personal data, sufficient to demonstrate compliance with the GDPR.
The documentation of the risk analysis is not sufficient to demonstrate that EuropeAid has selected all high risk subjects for audit.
The study was not designed to demonstrate efficacy in subgroups, andthe number of subjects≥ 85 years of age was not sufficient to demonstrate efficacy in this age group.
However, that factor shall in no case be sufficient to demonstrate that the activity is ancillary to the main business of the group.
As established by its harmonised classification, or presence on the candidate list,this is generally sufficient to demonstrate that it is not a suitable alternative.
The clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.
The RMS was therefore of the view that the in vitro data provided, supported by the animal PK and PD data,are sufficient to demonstrate a comparable in vivo behaviour.
The CHMP was concerned that the main study was not sufficient to demonstrate the effectiveness of Spanidin, because of the way it was designed and carried out.
The grounds for the referral were the concerns of some Member States that the data on Norditropin submitted in the application were not sufficient to demonstrate its effectiveness in Prader-Willi syndrome.
The spatial resolution of these data is poor,but it is sufficient to demonstrate that Charon's south pole has similarly dark red material at its surface.
The grounds for the referral were concerns that the data provided by the company, which included published data on other urokinase-containing medicines,were not sufficient to demonstrate that the benefits of Syner-Kinase outweigh its risks.
The CHMP concluded that the submitted data are not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
(a) the declaration, together with any evidence reasonably required by the competent authority to verify the information contained in it,shall be accepted by the competent authority as sufficient to demonstrate that the goods are lawfully marketed in another Member State; and.
As regards the applicants' claim that, even if, taken in isolation,the elements examined in paragraphs 115 to 122 above are not sufficient to demonstrate that Jindal Saw's export prices to its selling entities were reliable, taken together, those elements must be considered sufficient to demonstrate such reliability, it should be noted that those elements serve only as an indication.
If an alternative substance is equally or more hazardous than the Annex XIV substance for which the authorisation is applied for(e.g. as established by its harmonised classification, or presence on the candidate list),this is generally sufficient to demonstrate that it is not a suitable alternative.
The Committee was of the view that the available data were not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
(a) the declaration, together with any evidence reasonably required by the competent authority to verifyand the evidence supporting the information contained in it,shall be accepted by the competent authority as sufficient to demonstrate that the goods are lawfully marketed in another Member State; and.
Overall, the totality of the data provided by the company was considered sufficient to demonstrate that Diclofenac Sodium Spray Gel 4% is effective at treating joint swelling and pain due to trauma.
(a) the declaration together with supporting evidence in response to a reasoned request by the competent authority to verify the information contained in it,shall be accepted by the competent authority as sufficient to demonstrate that the goods are lawfully marketed in another Member State; and.
Member States shall ensure that monitoring for category B workers is at least sufficient to demonstrate that such workers are correctly classified in category B.
The mutual recognition declaration, together with supporting evidence necessary to verify the information contained in it that was provided in response to a request by the competent authority,shall be accepted by the competent authority as sufficient to demonstrate that the goods are lawfully marketed in another Member State; and.