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Dossier specifications for medicinal products The dossier referred to in Article 9(2) of this Regulation shall for medicinal products include the following information:

(a) the clinical safety and efficacy data included in the submission file to the European Medicines Agency;

(b) all up-to-date published and unpublished information, data, analyses and other evidence as well as study reports and study protocols and analysis plans from studies with the medicinal product for which the health technology developer was a sponsor and all available information on ongoing or discontinued studies with the medicinal product for which the health technology developer is a sponsor or otherwise financially involved, and corresponding information about studies by third parties if available, relevant to the assessment scope as set out in accordance with Article 8(6), including the clinical study reports and clinical study protocols if available to the health technology developer;

(c) HTA reports on the health technology subject to the joint clinical assessment;

(d) information on studies based on registries;

(e) if a health technology has been subject to a joint scientific consultation, the explanation from the health technology developer on any deviation from the recommended evidence;

(f) the characterisation of the medical condition to be treated, including the target patient population;

(g) the characterisation of the medicinal product under assessment;

(h) the research question elaborated in the submission dossier, reflecting the assessment scope as set out pursuant to Article 8(6);

(i) the description of methods used by the health technology developer in the development of the content of the dossier;

(j) the results of information retrieval;

(k) the characteristics of included studies;

(l) the results on effectiveness and safety of the intervention under assessment and the comparator;

(m) the relevant underlying documentation related to points (f) to (l).