Traduction de «réponse aux données-test » (Français → Anglais) :

[6] Please note that the category "Replies given" includes the replies given outside the scope of Regulation 10498/2001, for example replies given under Regulation 45/2001;

Following a request by the Commission for clarification as to whether the absence of statistically sufficient data on the performance of the tests is compensated by the procedure in place, which includes a ring trial with additional molecular testing methods in different laboratories and an evaluation by an expert panel chaired by the Community Reference Laboratory for TSEs, EFSA explained that:

When an application includes significant pre-clinical tests or significant clinical trials, significant new analyses or significant new data generated at the request of the competent authority and considered essential to the approval of the application, the competent authority shall not refer to those tests, trials, analyses or data in the examination of an application by another marketing authorisation holder for a change of classification of the same substance during a period of 3 years after the authorisation.

When an application includes significant pre-clinical tests or significant clinical trials, significant new analyses or significant new data generated at the request of the Competent Authority and deemed essential to the approval of the application, then the Competent Authority shall not refer to those tests, trials, analyses or data in the examination of an application by another marketing authorisation holder for a change of classification of the same substance during a period of 3 years after the authorisation".

34. Believes that, although it must do so, such a directive should not merely set out general principles derived from the entire body of fundamental rights (data must never be compiled unless they are intended to protect health or research; tests may be used only in specific cases and/or for particular purposes; tests may not be carried out without the consent of the person concerned; the use of data for given purposes should be prohibited; rules should be laid down to govern access to data not compiled on a strictly individual basis and in particular to deal with the problem of access within a family group, among blood relatives), but also lay down procedures for defining, classifying, and overseeing genetic testing so as to en ...[+++]sure that it is not put to improper use and to prevent the emergence of disturbing 'genetic normality' parameters;

In response to the European Data Protection Supervisor's exercise of his or her powers under Article 47(1)(b), the controller concerned shall inform the Supervisor of its views within a reasonable period to be specified by the Supervisor. The reply shall also include a description of the measures taken, if any, in response to the remarks of the European Data Protection Supervisor.