EU RAC EXAM QUESTIONS WITH ALL CORRECT ANSWERS
Significant changes to an Annex II list A IVD should be documented int he design dossier and reported to the notified body - Answer- on a continuous basis
The applicant shall inform the Notified Body that issued the EC design examination certifi...
Significant changes to an Annex II list A IVD should be documented int he design
dossier and reported to the notified body - Answer- on a continuous basis
The applicant shall inform the Notified Body that issued the EC design examination
certificate of any signficant change made to the approve design - Answer- In Vitro
Devices Directive (98/79/EC) Annex III
Abridged Application - Answer- an application for marketing authorization that, based
upon demonstrating essential similarity or by detailed references to published scientific
literature, does not contain the results of pharmacoligical and toxicological tests or the
results of clinical trials.
Acquis Communicataire - Answer- (Acquis), the collection of European laws to which all
EU member states must adhere
Active Implantable Medical Devices Directive - Answer- (AIMDD) First EU medical
legislation; sets general requirements relating to the design, construction adn CE
Marking of these devices and their accessories
Advanced Therapy Medicinal Product - Answer- (ATMP) A medicinal product that is
either a gene therapy medicinal product as defined in Part IV of Annex 1 to Directive
2001/83/EC, a somatic cell therapy medicinal product as defined in Part IV of annex 1 to
direct 2001/83/EC or a tissue engineered product as defined in Article 2 1 (b) of the
ATMP regulation.
AESGP - Answer- Association Eupeenne des Specialites Pharmaceutiques Grand
Public (Association of th eEuropena Self Medication Industry
Arbitration Rapportuer - Answer- Under the Mutual Recognition Procedure, the CHMP
member appointed to prepare a report after notification by the Reference and
Concerned Member States that are
Bibliographic Application - Answer- "Well established use application" The applicant
prepares a product dossier based upon literature available in the public domain. The
drug product concerned needs to have been on the market for at least 10 years.
Particularly important to newer member states as it allows them to keep their current
generic products on the market where no reference product exists.
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