‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan’.
«Les États membres peuvent, toutefois, autoriser les fabricants à entamer les investigations cliniques en question avant l'expiration du délai de soixante jours, à condition que le comité d'éthique concerné ait émis un avis favorable sur le programme d'investigations en question, y compris l'examen du protocole d'investigations cliniques».