Traduction de «Base d'évènement » (Français → Anglais) :

In determining whether an adverse event is an adverse reaction, consideration shall be given to whether there is a reasonable possibility of establishing a causal relationship between the event and the investigational medicinal product based on an analysis of available evidence.

The percentage of application of the severity classification based on the Risk Analysis Tool (RAT) methodology to the reporting of, as a minimum, three categories of occurrences: separation minima infringements, runway incursions and ATM-specific occurrences at all air traffic services units as defined in Section 2, point 1.1(b).

The percentage of application of the severity classification based on the Risk Analysis Tool (RAT) methodology to the reporting of, as a minimum, three categories of occurrences: separation minima infringements, runway incursions and ATM-specific occurrences at all air traffic services units as defined in Section 2, point 1.1(b).

Lithuania submitted the necessary information which in particular confirms that its bovine database is compatible with Article 5 of the Regulation: (i) the delays in notification of events are highlighted in the database and thus the deadlines for notifications of animal movements set in the Regulation are respected; (ii) that passports of animals moved outside of Lithuania are subsequently surrendered to the competent authority on arrival; (iii) there is an interface between the national bovine database and the national Agriculture Payment Scheme database as well as with the national Veterinary Information Management System to facilit ...[+++]ate reconciliation controls and the exchange of useful data; and (iv) guidelines are reinforced so that ear tags are issued and distributed in a correct manner and this information is available to the database.

1. Where the death of, or personal injury to, a passenger is caused by a shipping incident, the carrier who actually performed the whole or a part of the carriage when the shipping incident occurred shall make an advance payment sufficient to cover immediate economic needs on a basis proportionate to the damage suffered within 15 days of the identification of the person entitled to damages.

1. The method shall be event-specific and thus must only be functional with the GMO or GM based product considered and shall not be functional if applied to other events already authorised; otherwise the method cannot be applied for unequivocal detection/identification/quantification.