Free Access RAPS.RAC-GS.v2022-03-28.q35 Practice Test (Page 4)

Question 11

Which of the following is NOT required to be included in a marketing application?

A.Quality, safety, and efficacy Information

B.Evidence of fee payment

C.Final printed label

D.Administrative forms

Question 12

Which of the following claims would classify an apple as a drug?

A."It will satisfy hunger."

B."It will prevent colds."

C."It will make you look younger."

D."It will whiten teeth."

Question 13

During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?

A.As many as government attendees

B.All senior management from the main office

C.The minimum number of attendees necessary to address the issues

D.As many as required by international standards

Question 14

The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug
produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly
different color and break easily.
Which of the following actions should the regulatory affairs professional take?

A.Respond to the regulatory authority that the company will provide copies of the relevant QC records for
batch release.

B.Ask that the regulatory authority provide the batch number printed on the packaging of the affected
product.

C.Ask that the regulatory authority provide the actual product subject to the complaint.

D.Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit
product.

Question 15

What are the MOST important elements that global regulatory agencies want to know before approving a
new product for sale in their countries?

A.Safety and failure risk

B.Quality and effectiveness

C.Quality and failure risk

D.Safety and effectiveness

Other Version: 37RAPS.Braindumpspass.RAC-GS.v2021-11-08.by.merle.33q.pdf

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Question 11

Question 12

Question 13

Question 14

Question 15

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