A study of one or more medicinal products which have a marketing authorisation, where the following conditions are met:
a) The products are prescribed in the usual manner in accordance with the terms of that authorisation
b) The assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol
but falls within current practice
c) The decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study
d) No diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily
applied in the course of the particular therapeutic strategy in question, and
e) Epidemiological methods are to be used for the analysis of the data arising from the study.
