University of Pune 2010 B.Pharm Pharmaceutical Jurisprudence And Regulatory Affairs - Question Paper

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Fourth Year B.Pharm. Examination, 2010
Pharmaceutical Jurisprudence And Regulatory Affairs(2004 Course)
Time : three Hours
Max. Marks : 80
Instructions:
1) ques. Nos. one and five are compulsory. Out of remaining, attempt two ques. from part I and two ques. from part II.
2) Answers to the 2 parts should be written in separate books.
3) Figures to the right indicate full marks.

part – I
1. describe "Illicit Traffic". explain power of Central Government to permit, control and regulate certain operations under NDPS 1985. 10

2.
A) elaborate the qualifications and duties of Drug Inspector ? provide procedure of Inspections. 9
B) explain the requirements of Non-bonded Laboratory. Write procedure for obtaining rectified spirite under Non-bonded Laboratory. 6

3.
A) describe 'Advertisement'. define the provisions pertaining classes of prohibited advertisement and Exempted advertisement. 10
B) Differentiate in ranging from State and Joint State Pharmacy Council under Pharmacy Act 1948. 5

4. Write short notes on (any three) : 15
1) Industrial Safety and Health
2) Consumer Protection Act
3) Public Analyst
4) D.T.A.B.

part – II
5.
A) describe Patents. explain in brief the filling and processing of Patents. 7
B) describe IPR, add note on Trade marks. 3

6.
A) explain in brief about 8
a) Europe-European Agency for the valuation of medicinal product.
b) Medicine Control Agency
B) explain ICH Guidelines. 7

7.
A) explain in brief salient features of Indian Patents Act 1970. 7
B) Differentiate ranging from NDA and ANDA. Write note on 'contents of ANDA. 8

8. Write short note on (any three) : 15
1) US-FDA
2) Exclusive Marketing Right
3) Patent infringement
4) TGA.

Earning:   Approval pending.