Subsection 1: Application for authorisation.

The application provided for in Article R. 5121-21 must be accompanied by a dossier containing the following information and documents, updated as necessary, presented in accordance with the order referred to in Article R. 5121-11:

1° Chemical, pharmaceutical and biological data ;

2° The results of pre-clinical tests and clinical trials;

3° A summary describing the pharmacovigilance system of the future authorisation holder or of the company exploiting the proprietary medicinal product and comprising the following elements :

a) A declaration signed by the applicant stating that the future authorisation holder or the company exploiting the proprietary medicinal product has a qualified person responsible for pharmacovigilance in a Member State of the European Union or a State party to the Agreement on the European Economic Area;

b) The Member State in which the qualified person resides and carries out his activities;

c) The contact details of the qualified person responsible for pharmacovigilance;

d) A declaration signed by the applicant stating that the future authorisation holder or the company exploiting the proprietary medicinal product has the necessary means to fulfil the tasks and responsibilities incumbent upon it in the field of pharmacovigilance;

e) The address of the place where the pharmacovigilance system permanent file corresponding to the medicinal product concerned is kept;

3° bis The risk management plan describing the risk management system, the model for which is laid down by the European Commission, to be implemented by the future authorisation holder or the company exploiting the proprietary medicinal product for the medicinal product concerned, accompanied by its summary;

4° Therapeutic indications, contraindications and adverse reactions;

5° Dosage, pharmaceutical form, method and route of administration and presumed duration of stability;

6° An explanation of the precautionary and safety measures to be taken when storing the medicinal product, administering it to the patient and disposing of waste;

7° A declaration by the applicant that clinical trials conducted outside the European Union or the European Economic Area meet ethical requirements equivalent to those of Directive 2001/20/EC of 4 April 2001;

8° A declaration stating that the manufacturer of the proprietary medicinal product has verified that the manufacturer of the active substance has complied with good manufacturing practice by carrying out audits.

This declaration states the date of the audit and attests that the results obtained make it possible to affirm that the manufacture complies with good manufacturing practice.

9° One or more mock-ups or samples of the outer packaging and the immediate packaging and, if applicable, the draft package leaflet accompanied by the results of the assessment of its legibility, clarity and ease of use, carried out in cooperation with target groups of patients;

10° A copy of the decisions authorising the manufacture of the medicinal product concerned and issued, as the case may be, either under the manufacturer's national legislation or pursuant to Articles R. 5124-6, R. 5124-7 and R. 5124-10 or, where applicable, a copy of the receipts of the applications for authorisation if the said applications have not yet given rise to a decision;

11° A copy of the marketing authorisations obtained for this medicinal product, either in another Member State of the European Union or State party to the Agreement on the European Economic Area, or in a third country, accompanied by summaries of the safety information including the data contained in the periodic safety update reports, where available, and reports of suspected adverse reactions, summaries of the product characteristics and package leaflets when the authorisations were obtained in another Member State of the European Community or State party to the Agreement on the European Economic Area;

12° A list of the Member States of the European Union or States party to the Agreement on the European Economic Area in which marketing authorisation applications for the same medicinal product have been submitted and are under examination, together with the proposed summaries of product characteristics and package leaflets;

13° A copy of any decisions to refuse marketing authorisation for this medicinal product taken in a Member State of the European Union or State party to the Agreement on the European Economic Area or in a third country, together with the reasons for these decisions;

14° Assessment and indication of the risks that the medicinal product is likely to present for the environment; this impact is studied and, on a case-by-case basis, specific provisions aimed at limiting it are envisaged.