Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2019 June (Master of Pharmacy) 1st Year (First Year) 2nd Year 5147 International Pharmaceutical Regulations II Previous Question Paper

Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Degree Examination - JUNE 2019
[Time: 3 Hours]
[Max. Marks: 75]
International Pharmaceutical Regulations-II
Q.P. CODE: 5147
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three)
3 X 10 = 30 Marks
1.
What do understand by emerging market? What led to the genesis of SADC and who are the
member countries? Write briefly about regulatory requirements for registration of drugs in one
of the SADC countries?
2.
Explain in detail about WHO Prequalification program. Add a note on regulatory requirements
for registration of drugs in Egypt.
3.
Explain in detail the ACTD? Name the countries in ASEAN and write about regulatory
requirements for registration of drugs in China.
4.
Prepare the check list of documents required for marketing pharmaceutical products in Russia.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Write a note on APEC region.
6.
Explain briefly the countries under PANDRH? Which are the regulatory agencies of those
countries?
7.
Explain the process of obtaining CoPP in South Africa.
8.
What are market authorization requirements for drugs in Vietnam?
9.
What are the different countries which are under ASEAN Market and their regulatory
authorities?
10.
Explain the regulatory requirements for registration of drugs in South Korea.
11.
Write a short note on Post approval requirements in CIS countries.
12.
What are the market authorization requirements for Kazakhstan?
13.
Regulatory pre-requisites for market authorization of drugs in UAE.
14.
What are the stability requirements for finished products to be marketed in GCC countries?
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