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EU RAC Exam 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+
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EU RAC Exam 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+
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EU RAC Exam 2024 | Questions with100% Correct Answers | Verified |
Latest Update | Graded A+
Advanced Therapy Medicinal Product - ✔✔(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 - ✔✔Association Eupeenne des Specialites Pharmaceutiques Grand
Public (Association of th eEuropena Self Medication Industry
Arbitration Rapportuer - ✔✔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 - ✔✔"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.
Blue Box - ✔✔the area into which country specific text is usually placed
on packaging materials and leaflets for medicinal products approved via
the Centralized Procedure.
Centralized Procedure - ✔✔submission of a dossier to EMA to obtain marketing
authorization from the EC that is valide in all EU member states. The CP is
mandatory for orphan medicinal products; any medicinal product for human use
containing an entirely new active substance; thsoe manufactured using biotech
processes; and medicinal products for the treatment of AIDS, cancer,
neurodegenrative disorders, auto-immune diseases, andother immune
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