Traduction de «utilisation hors indication » (Français → Anglais) :

(32c) Medically justified use not in accordance with indications: specific case of use deliberately not in compliance with the recommendations under the ‘indications’ section of the summary of the product characteristics but based on the assessment data’.

(h) in some countries, off-label use of drugs, that is to say, not in accordance with the specifically authorised indications and forms of administration, is viewed as a valid therapeutic alternative, even though its efficacy might not be proven. It could, however, constitute a risk and should therefore be carefully regulated;

26. Invites the Commission to already use – and improve – existing resource efficiency indicators where available and set targets without any delay in close cooperation with the Member States and all other interested parties, and to develop as soon as possible new indicators and targets where needed, as requested in the Roadmap; calls on the Commission, in view of the limitations of the flagship indicator on resource productivity, to define an indicator for material consumption, using a lifecycle-based approach that integrates hidden ...[+++] flows, i.e. the potential for environmental pressures to be transferred outside the EU, and movements of shortfalls and dependencies, without delay;

(15) In order to establish the electronic network, the power to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the conditions for countries outside the European Economic Area to participate in the electronic network, the minimum security standards, the use of a unique identifier, the languages used by the electronic network, the method of transmitting information between the registers ensuring cross-border access to information, the interoperability of the information and communication technologies used by the members of the el ...[+++]ectronic network, the definition of standards on format, substance and limits for storing and retrieving the documents and particulars that enables automated data exchange, the consequences of non-compliance, the method of identifying the link between a company and its foreign branch, the method of and the technical standards for the transmission of information between the register of the company and the register of the branch, the technical standards for the transmission of information between the registers and the standard forms of notification of the cross-border merger to be used by the registers.

(15) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the governance, management, operation, representation and funding of the electronic network, the conditions for countries outside the European Economic Area to participate in the electronic network, the minimum security standards, the use of a unique identifier, the languages used by the electronic network, the method of transmitting information between the registers ensuring cross-border access to information, the interoperability of the information and communication technolo ...[+++]gies used by the members of the electronic network, the definition of standards on format, substance and limits for storing and retrieving the documents and particulars that enables automated data exchange, the consequences of non-compliance, the method of identifying the link between a company and its foreign branch, the method of and the technical standards for the transmission of information between the register of the company and the register of the branch, the technical standards for the transmission of information between the registers and the standard forms of notification of the cross-border merger to be used by the registers.

We stand ready to respond to requests from our customers for evidence on off-label drug use and other topics related to the optimal use of drugs and other health technologies.