7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Directive 2001/83/EC.

7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Directive 2001/83/EC.

10. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the relevant methods specified in Annex I to Directive 2001/83/EC.

10. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Directive 2001/83/EC.

(6) Medical devices incorporating, as an integral part, a substance derived from human blood or plasma and which is liable to act upon the body with action ancillary to that of the device must comply with the provisions of Directive 93/42/EEC and other instruments supplementing the said Directive.

VCOMMMUNITY HEALTH STRATEGY PAGEREF _Toc487885275 \h VFOLLOW-UP TO THE EVORA CONFERENCE ON HEALTH DETERMINANTS IN THE EUROPEAN UNION RESOLUTION PAGEREF _Toc487885276 \h VIIFOLLOW-UP TO THE LISBON CONFERENCE ON MEDICINAL PRODUCTS AND PUBLIC HEALTH CONCLUSIONS PAGEREF _Toc487885277 \h IXWHO FRAMEWORK CONVENTION ON TOBACCO CONTROL PAGEREF _Toc487885278 \h XFOLLOW UP TO THE FEIRA EUROPEAN COUNCIL PAGEREF _Toc487885279 \h XOTHER BUSINESS PAGEREF _Toc487885280 \h X-EXPERTS CONFERENCE ON QUALITY AND SAFETY IN TRANSPLANTING TISSUES AND ORGANS OF HUMAN ORIGIN PAGEREF _Toc487885281 \h X-MEDICAL DEVICES FOR SELF TESTING OF HIV PAGEREF _Toc487885282 \h X-ASSESSMENT OF THE OPERATION OF DIRECTIVE 93/42 CONCERNING MEDICAL DEVICES PAGEREF _Toc487885283 \h ...[+++]XI-ERRORS WHEN ADMINISTERING INTRAVENOUS INJECTIONS IN EMERGENCY SITUATIONS PAGEREF _Toc487885284 \h XI-INFORMING CONSUMERS OF THE RISKS OF USING MOBILE PHONES PAGEREF _Toc487885285 \h XI-FOLLOW-UP TO THE KOHLL AND DECKER CASES PAGEREF _Toc487885286 \h XI-ASSESSMENT OF THE EPIDEMIOLOGICAL SITUATION WITH RESPECT TO NEW VARIANT CREUZFELDT-JAKOB DISEASE PAGEREF _Toc487885287 \h XIITEMS APPROVED WITHOUT DEBATEHEALTH PAGEREF _Toc487885288 \h XI--Medical devices incorporating stable derivatives of human blood or human plasma PAGEREF _Toc487885289 \h XIFISHERIES PAGEREF _Toc487885290 \h XII--Agreement with Mauritius PAGEREF _Toc487885291 \h XII--Collection and management of fisheries data * PAGEREF _Toc487885292 \h XIITRANSPORT PAGEREF _Toc487885293 \h XIII--TIR Convention PAGEREF _Toc487885294 \h XIIIINDUSTRY PAGEREF _Toc487885295 \h XIII--Promoting sustainable development in the EU non-energy extractive industry PAGEREF _Toc487885296 \h XIIISOCIAL AFFAIRS PAGEREF _Toc487885297 \h XIV--Combating racial discrimination PAGEREF _Toc487885298 \h XIV--Social Protection Committee PAGEREF _Toc487885299 \h XIV--Balanced participation of women and men in family and working life PAGEREF _Toc487885300 \h XVENVIRONMENT PAGEREF _Toc487885301 \h XV-- ...