Traduction de «diffusion d'avis de résolution » (Français → Anglais) :

1. As soon as the marketing authorisation holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product, and in any event at the same time or before the public announcement is made, he shall be required to inform the national competent authorities, the Agency and the Commission.

To the same end, the marketing authorisation holders should provide the competent authorities with prior or simultaneous warnings about safety announcements and the competent authorities should also provide each other with advance notice of safety announcements.

specific actions taken by the Commission, such as studies and research, opinion polls and surveys, development of indicators and methodologies, collection, development and dissemination of data and statistics, seminars, conferences and experts meetings, organisation of public campaigns and events, development and maintenance of a helpdesk service and websites, preparation and dissemination of information materials (including IT applications and training resources), establishment and facilitation of a stakeholder think-tank providing expert advice related to violence, support to other networks of national experts, and analytical, monitori ...[+++]ng and evaluation activities;

[63] See website [http ...]

(6) The Council in its Conclusions of 26 November 1998 on the future framework for Community action in the field of public health(17), and in its Resolution of 8 June 1999(18), the Economic and Social Committee, in its opinion of 9 September 1998(19), the Committee of the Regions, in its Opinion of 19 November 1998(20), and the European Parliament, in its Resolution A4-0082/99 of 12 March 1999(21), welcomed the Commission communication of 15 April 1998 and supported the view that actions at Community level should be set out in one overall programme to run for a period of at least five years and comprising three general objectives, namely ...[+++] improving information for the development of public health, reacting rapidly to health threats and tackling health determinants through health promotion and disease prevention, underpinned by inter-sectoral action and the use of all appropriate Treaty instruments.

1. As soon as the marketing authorisation holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product, and in any event at the same time or before the public announcement is made, he shall be required to inform the national competent authorities, the Agency and the Commission.