Translation of "Applicant information" in German

The applicant submitted that information to the rapporteur Member State Sweden within the time period provided for its submission.

The applicant shall provide information about the whole method.

The applicant shall provide information on the following elements:

The observers wish to find out how the applicant handles information.

DE 10 2006 032 926 by the present applicant provides additional information in this regard.

Professional/Applicant Qualifications Information (e.g., work experience, education, reference information)

The applicant provided information and supporting evidence in response to a questionnaire from the Commission.

The applicant also provided information about further production facilities that are being set up and the size of the domestic market.

The applicant even withdrew information given before, claiming that it was wrong or imprecise.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 March 2013.

Those documents shall be forwarded to the Commission, to Member States and to the applicant for information purposes.

The competent authorities of the host Member State may invite the applicant to provide information concerning his training to the extent necessary in order to determine the existence of potential substantial differences with the required national training, as laid down in Article 14.

The Commission shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant and the Authority of its decision.

Based on the information provided by the applicant, and other information available, the EFSA has considered that certain products of ingredients are not likely, or not very likely, to cause adverse reactions in susceptible individuals.

The applicant, based on information in the non-confidential file, argued that the reply to the questionnaire of the Indonesian producer was apparently inadequate and there was only information to make a rough calculation of constructed normal value.

The assisting authority shall provide the applicant with the information referred to in Article 4 and the required application forms, on the basis of the manual drawn up in accordance with Article 13(2).

The Applicant/MAH provided information on the antigen content of the batches of vaccine used in the field studies.

The applicant also presented information from two main studies looking at the effects of pantoprazole 20 mg in a total of 563 adults who had symptoms of acid reflux, including at least one episode of heartburn in the three days before the studies began.

However, with the agreement of the applicant, the information and translations may be forwarded directly by the customs-authority service which took the decision.

In conclusion, the CHMP considered that the Applicant provided limited information on the patient treatment (titration towards an efficient dose, multiple administrations, administration up to the highest dosage) which prevented an evaluation of efficacy and safety of Rapinyl in the clinical setting and characterisation of the full clinically relevant time effect profile of the drug.

In order to address the concern of the extended (lengthened ring use) of up to 28 days, which is a deviation from the recommended use that is included in the SmPC of NuvaRing, the applicant provided further information on pharmaceutical quality data between the test and reference medicinal product, in vitro dissolution data which evaluated the rate of release of the test and reference product over 28 days, In Vitro-In Vivo Correlation (IVIVC) for the reference formulation for 28 days and an In Vitro-In Vivo Correlation (IVIVC) for the test formulation for 21 days, and the residual contents in the rings of etonogestrel and ethinyelstradiol at 21 days for test and reference medicinal product.