Traduction de «obligation d'autorisation » (Français → Anglais) :

a requirement at the time of marketing authorisation applications for data on the use of the medicine in children resulting from an agreed paediatric investigation plan ; a system of waivers from the requirement for medicines unlikely to benefit children; a system of deferrals of the timing of the requirement to ensure medicines are tested in children only when it is safe to do so and to prevent the requirements delaying the authorisation of medicines for adults.

principles for environmental risk assessment (see below); mandatory post-market monitoring requirements, including on long-term effects associated with the interaction with other GMOs and the environment; mandatory information to the public; a requirement for Member States to ensure labelling and traceability at all stages of the placing on the market, a Community system for which is provided for by Regulation 1830/2003 on traceability (see below); information to allow the identification and detection of GMOs to facilitate post-market inspection and control; first approvals for the release of GMOs to be limited to a maximum of ten years; the consultation of the Scientific Committee(s)/European Food Safety Authority (EFSA) to be obliga ...[+++]tory; an obligation to inform the European Parliament on decisions to authorise the release of GMOs and the possibility for the Council of Ministers to adopt or reject a Commission proposal for authorisation of a GMO by qualified majority.

a requirement at the time of marketing authorisation applications for data on the use of the medicine in children resulting from an agreed paediatric investigation plan ; a system of waivers from the requirement for medicines unlikely to benefit children; a system of deferrals of the requirement to ensure medicines are tested in children only when it is safe to do so and to prevent the requirements delaying the authorisation of medicines for adults.

principles for environmental risk assessment (see below); mandatory post-market monitoring requirements, including on long-term effects associated with the interaction with other GMOs and the environment; mandatory information to the public; a requirement for Member States to ensure labelling and traceability at all stages of the placing on the market, a Community system for which is provided for by Regulation 1830/2003 on traceability (see below); information to allow the identification and detection of GMOs to facilitate post-market inspection and control; first approvals for the release of GMOs to be limited to a maximum of ten years; the consultation of the Scientific Committee(s)/European Food Safety Authority (EFSA) to be obliga ...[+++]tory; an obligation to consult the European Parliament on decisions to authorise the release of GMOs and the possibility for the Council of Ministers to adopt or reject a Commission proposal for authorisation of a GMO by qualified majority.

However, in specific cases where the replacement of authorisations existing on the date of entry into force of this Directive by the general authorisation and the individual rights of use in accordance with this Directive would lead to an increase in the obligations for service providers operating under an existing authorisation or to a reduction of their rights, Member States may avail themselves of an additional nine months after the date of application of this Directive for alignment of such licences, unless this would have a negat ...[+++]ive effect on the rights and obligations of other undertakings.

1. Without prejudice to information and reporting obligations under national legislation other than the general authorisation, national regulatory authorities may only require undertakings to provide information under the general authorisation, for rights of use or the specific obligations referred to in Article 6(2) that is proportionate and objectively justified for: