RA GENERAL KNOWLEDGE (LOCAL REGISTRATION)

What is NPRA? And NPRA stands for?

What are guidelines that can be used as a reference (You may select more than one)

EMA

WHO

DRGD

NPRA

How many product classification are stated in the DRGD? Can you name it one by one?

What are generic products?

Product that is essentially similar to a currently registered product in Malaysia

Product that have not been previously registered

Products used to supplement a diet

3) In RA, we are using system ___________ for variation/document submission to NPRA.

NPRA

Quest3+

MDA

Quest

List 3 license often applied by RA.

List at least 3 manufacturing sites in Pharmaniaga

List 3 certificates often applied by RA.

ASEAN Common Technical Dossier consists of these

Part I - IV

Module 1 - 5

Part I & Part II

Part II of the ACTD dossier consist of (You may select more than one)

Administrative Data

Product information

Drug Product

Drug Substance

Submission of the renewal must be within _________ of the product expiry

1 year

3 months

6 months

Please rearrange the registration process below:

Screening

Dossier Acceptance

Technical Assessment

Assessment Complete

DCA Meeting

Final Decision

What are the Post-Registration Activities (You may select more than one)

Renewal

Post Market Surveillance

Amendment (Variation)

Withdrawal

If there are changes proposed by the manufacturing site on the registered product, what should RA do?

Should the registered product is no longer active in the market, how can we withdraw the registration of the product?

Let the registration lapse

Submit official letter to NPRA

Recall all products in the market

Submit amendment to NPRA

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