1. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
2. Which type of research involves intervention, treatment, or medication programs using human subjects?
3. What are "Medical Devices" under Schedule-I?
4. What is the tenure of the CEO's appointment, and how many times can it be extended?
5. Who serves as the ex-officio Chairman of the Appellate Board?
6. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
7. Which of the following is NOT a source of financing the Drug Regulatory Authority Fund?
8. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
9. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
10. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
11. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
12. In which circumstances may the Registration Board register a drug on its own motion?
13. What type of containers are ophthalmic solutions and suspensions required to be contained in?
14. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
15. Within what time frame should the Authority submit its annual report to the Federal Government?
16. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
17. What is the purpose of the Committee on Drugs Evaluation?
18. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
19. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
20. What is the fee for the renewal of registration of a new drug?
21. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
22. What ethical criteria should be followed for medical drug promotion?
23. What is the penalty for a person who fails to provide information requested by the Authority?
24. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
25. What action should the Authority take in response to objections raised by the Auditor-General?
26. What does the term "batch number (or lot number)" refer to?
27. Which type of ophthalmic preparations is allowed to have a preservative?
28. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
29. What is the penalty for a person who fails to provide information requested by the Authority?
30. What action should the Authority take in response to objections raised by the Auditor-General?
31. What is the purpose of an "airlock" in pharmaceutical manufacturing?
32. The Authority shall levy and collect fees for its functions at rates determined by:
33. What is the term of office for members of the Registration Board?
34. Which of the following offenses punishable under Schedule-III is non-cognizable?
35. Under what conditions is contract manufacture permissible?
36. What is the primary function of the Federal Drug Laboratory as stated in the rules?
37. What is the role of the Quality Control Department in the manufacturing process?
38. What is the purpose of an "airlock" in pharmaceutical manufacturing?
39. According to the schedule in the Drugs (Specifications) Rules, what specifications should drugs bear that reference publications specified under sub-clause (ii) of clause (z) of Section 3?
40. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
41. Which of the following criteria should promotional claims about drugs adhere to?
42. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
43. Which of the following is NOT considered as "Therapeutic goods" under the Act?
44. What is the purpose of the license to manufacture drugs for experimental purposes?
45. What substances are NOT included in the definition of "Drug" under Schedule-I?
46. What does the term "Advertise" mean under Schedule-II?
47. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
48. What are "Medicated Cosmetics" under Schedule-I?
49. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
50. What must be included in the labelling and promotion of a registered drug?
51. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
52. The Drugs Act, 1976 extends to which of the following areas?
53. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
54. When does an Inspector need to divide a sample into three portoons instead of four?
55. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
56. What is the Appellate Board's authority to call for the record of a case for review?
57. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
58. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
59. Who is responsible for carrying out the audit of the Authority's accounts?
60. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
61. What condition must be met for an application for renewal of a licence to be entertained?
62. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
63. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
64. What is the duration of a license to import drugs, unless suspended or canceled?
65. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
66. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
67. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
68. What is the purpose of 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976'?
69. What provision allows an exporter to recall issues already made from a batch of drugs that have been found to be in contravention of the Act or rules of 1976?
70. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
71. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
72. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
73. Which of the following statements about advertisement material is NOT true?
74. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
75. What is the main duty of a Federal Inspector?
76. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
77. What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?
78. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
79. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
80. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
81. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
82. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
83. What is the purpose of Form 6?
84. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
85. What is the purpose of the Drugs (Research) Rules, 1978?
86. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
87. What is the purpose of the criteria regarding medical representatives?
88. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
89. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
90. How many members does the Policy Board consist of?
91. What are "Medical Devices" under Schedule-I?
92. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
93. What is the purpose of Form 10 in the export of drugs?
94. What is the purpose of Schedule-III of the DRAP Act?
95. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
96. What is the commencement date for the Drugs (Specifications) Rules, 1978?
97. When can deviations be made from the information submitted during the registration of a drug?
98. The Central Research Fund fee collected by the Authority will be utilized for:
99. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
100. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
