The technical file compiled by the designated body and accompanying the certificate of verification in the case of national rules must be included in the technical file accompanying the “EC” declaration of verification referred to in point 2.4 and shall contain the technical data relevant for the assessment of the conformity of the subsystem with those national rules.

(51) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission relating to: the content of the file which shall accompany the request of non-application of one or more TSIs or parts of them, the details, the format and the transmission modalities of that file; the scope and the content of the EC declaration of conformity and suitability for use of interoperability constituents, its format and the details of the information included in it ; the classification of the notified national rules in different groups with the aim of facilitating the compatibility checks between fixed and mobile equipment; the verification ...[+++] procedures for subsystems, including the general principles, the content, procedure and documents related to the ‘EC’ verification procedure, and to the verification procedure in the case of national rules; the templates for the ’EC’ declaration of verification and for the declaration of verification in the case of national rules and templates for documents of the technical file that has to accompany the declaration of verification; the common specifications relating to content, data format, functional and technical architecture, operating mode and rules for data input and consultation for the register of infrastructure.

My thanks also go to the Commission, whose officials dealing with these matters have always been supportive and professional, so thank you, everyone!

A summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the Pharmacovigilance System Master File for the medicinal product concerned is maintained and accessible for inspection.

(6) The marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products, recorded in a Pharmacovigilance System Master File permanently accessible for inspection.

(22) Whereas it is essential that, before issuing an EC declaration of conformity, the manufacturer or his authorised representative established in the Community should provide a technical construction file; whereas it is not, however, essential that all documentation be permanently available in a material manner, but it must be made available on demand; whereas it need not include detailed plans of the sub-assemblies used in manufacturing the machines, unless knowledge of these is indispensable in order to ascertain conformity with essential safety requirements;