220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

24cemCE marking (of a medical device) The CE marking of conformitymust appear in a visible, legible and indelible form on the deviceor its sterile pack (where practicable and appropriate), and on theinstructions for use. where applicable, the CE marking must alsoappear on the sales packaging. The CE marking must be accompaniedby the identification number of the notified body responsiblefor implementation of the respective quality and conformity procedures;for devices which are custom-made or devices intendedfor clinical investigations special regulations will be established;these devices do not bear the CE marking; → see also ec typeexaminationcertificate.censored data Values which are not known at the time of analysis,but which have a known minimum value (e.g. survival).central ethics committee syn. Lead Ethics Committee; ethics committeereviewing a protocol for different institutions, e.g. in amulticentre or multinational trial; in the EU the vote of one ECper country is (legally) sufficient, frequently however, the formalapproval by the ethics committee of each participating hospital isrequested in addition; in other countries, e.g. France, approval byone central e.c. is sufficient.centralised procedure former: concertation procedure, formerhigh technology procedure; mandatory procedure in the EC forgetting marketing authorization for all biotechnology products(products developed by recombinant DNA technology, monoclonalantibody methods, gene and cell therapies, etc.), optionalfor other biotech products and new chemical entities (productsof significant therapeutic interest or innovation); presentation tothe commitee for proprietary medicinal products (CPMP) isa must unless the application is accompanied by a signed declarationthat no other application has been made during the precedingor will be made during the next 5 years resp.); presentation tothe european medicines evaluation agency (EMEA) and CPMPresp. is undertaken by the company, the rapporteur memberstate will be appointed by the CPMP after discussion with thecompany; the CPMP has 210 days for examination and to reach itsopinion which is then send to the Commission, member states andthe applicant, including the assessment report, the summary ofproduct characteristics, the labelling and the package insert;the Commission has then 30 days for decision, after whichthe member states have 28 days for raising questions; then theapplication goes to the standing committee (with representativesfrom the member states) and becomes a final Commission’s decisionif the majority is in favour; the total time to approval shouldbe max. 300 days, the final decision will be binding for all member