BUSINESS OVERVIEW 6 provides for the obligation to comply with standards adopted by SPC, labeling, or packaging proposed by the RMS, the product is the CNIL, and file simplified formalities in this respect. subsequently granted a national MA in all the Member States (i.e. in the RMS and the CMSs). European Union Marketing Authorizations In the EEA, medicinal products can only be commercialized after Under the above described procedures, before granting the MA, obtaining a marketing authorization or MA, from the competent the EMA or the competent authorities of the Member States of regulatory authorities. There are different types of marketing the EEA make an assessment of the risk-benefit balance of the authorizations including: product on the basis of scientific criteria concerning its quality, safety and efficacy. Centralized Procedure Mutual Recognition Procedure A centralized MA is issued by the European Commission through the centralized procedure, based on the opinion of the CHMP Where a product has already been authorized for marketing and is valid in all EU Member States and throughout the entire in a Member State of the EEA, the existing national MA can territory of the EEA. be recognized in another Member States through the mutual recognition procedure. The centralized procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan Regulatory Approval of Medical Devices in the European Union medicinal products, and medicinal products containing a new Premarket approval of medical devices does not exist in the active substance indicated for the treatment of acquired immune European Union; however, the European Union has adopted deficiency syndrome, or AIDS, cancer, neurodegenerative numerous directives and standards regulating, among other disorders, diabetes, auto-immune and viral diseases. The things, the design, manufacture, clinical trials, labeling, approval centralized procedure is optional for products containing a new and adverse event reporting for medical devices. active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical The conformity assessment of medical devices with the essential innovation or which are in the interest of public health in the requirements varies depending on the classification of the device European Union. and the directive that is applicable. The lowest-risk devices require only a self-declaration of conformity by the manufacturer. National MAs, which are issued by the competent authorities of Higher-risk devices require the involvement of third-party bodies the Member States of the EEA and only cover their respective cal led “notified bodies,” which are certification organizations territory, are available for products not fal ling within the designated by the competent authorities of member states to mandatory scope of the centralized procedure. carry out the conformity assessment procedures described in the Medical Devices Directives. The notified body’s tasks will vary When a medicinal product does not fal l within the mandatory depending on the classification of the products concerned and the scope of the Centralized Procedure, the applicant may use the conformity assessment route a manufacturer has chosen. decentralized procedure or the mutual recognition procedure in order to obtain a marketing authorization in one or more countries Medical devices which comply with the essential requirements in the European Union. In these cases, the competent authorities of the Medical Devices Directives must bear the conformity of the Member States will issue the MA. CE-marking when marketed in EU Member States. The CE- marking has to be placed visibly and legibly on the product or, if Decentralized Procedure not possible due to the nature of the product, be affixed to the If the product has not received a national MA in any Member packaging and the accompanying documentation. If a notified State at the time of application, it can be approved simultaneously body has been involved in the conformity assessment procedure, in various Member States through the decentralized procedure. its identification number must also be displayed. Under the decentralized procedure, an identical dossier is Compliance with these requirements is a prerequisite to be submitted to the competent authorities of each of the Member able to affix the CE Mark of Conformity to medical devices, States in which the MA is sought, one of which is selected by the without which they cannot be marketed or sold in the EEA. Actual applicant as the Reference Member State, or RMS. The competent implementation of these directives, however, may vary on a authority of the RMS prepares a draft assessment report, a draft country-by-country basis. summary of the product characteristics, or SPC, and a draft of the labeling and package leaflet, which are sent to the other French Pharmaceutical Company Status Member States (referred to as the Concerned Member States, or To date, we do not have the status of pharmaceutical establishment, CMSs) for their approval. If the CMSs raise no objections, based and therefore, cannot either manufacture the product candidates on a potential serious risk to public health, to the assessment, we develop or directly consider their commercialization. 88 – GENSIGHT BIOLOGICS – 2017 Registration Document