Traduction de «Méthode d'évaluation à prime unique périodique » (Français → Anglais) :

3. By way of derogation from the preceding paragraphs, the identification requirements with regard to insurance policies written by insurance undertakings within the meaning of Council Directive 92/96/EEC of 10 November 1992 on the coordination of laws, regulations and administrative provisions relating to direct life assurance (third life assurance Directive)(14), where they perform activities which fall within the scope of that Directive shall not be required where the periodic premium amount or amounts to be paid in any given year does or do not exceed EUR 1000 or where a single premium is paid amounting to EUR 2500 or less.

There are, for example, step-based no-claims bonus systems that do not impose any mandatory rebate/surcharge coefficient and in which insurers are free to decide on how the premium is determined, taking account of the seriousness of the claim or of the number of penalty points, not merely the number of accidents, and freely assessing the economic impact of each factor on the premium (as insurers do when they calculate the amount of the basic premium).

1. A single assessment of periodic safety update reports shall be performed for medicinal products authorised in more than one Member State and, in the cases of paragraphs 4 to 6 of Article 107c, for all medicinal products containing the same active substance or the same combination of active substances and for which a Union reference date and frequency of periodic safety update reports has been established.

4. Where medicinal products that are subject to different marketing authorisations contain the same active substance or the same combination of active substances, the frequency and dates of submission of the periodic safety update reports resulting from the application of paragraphs 1 and 2 may be amended and harmonised to enable a single assessment to be made in the context of a periodic safety update report work-sharing procedure and to set a Union reference date from which the submission dates are calculated.

There are, for example, step-based no-claims bonus systems that do not impose any mandatory rebate/surcharge coefficient and in which insurers are free to decide on how the premium is determined (taking account of the seriousness of the claim or of the number of penalty points, not merely the number of accidents, and freely assessing the economic impact of such factors on the premium, as insurers do when they calculate the amount of the basic premium).

—to provide, where appropriate, periodic assessments of policy or program effectiveness, of impacts both intended and unintended, and of alternative ways of achieving expected results.