1. What does the term "Advertise" mean under Schedule-II?
2. Who qualifies as a Federal Inspector according to these rules?
3. 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?
4. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
5. What action should the Authority take in response to objections raised by the Auditor-General?
6. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
7. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
8. What is the tenure of the CEO's appointment, and how many times can it be extended?
9. What is the purpose of the Committee on Drugs Evaluation?
10. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
11. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
12. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
13. Which of the following offenses punishable under Schedule-III is non-cognizable?
14. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
15. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
16. When can deviations be made from the information submitted during the registration of a drug?
17. Which of the following statements about advertisement material is NOT true?
18. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
19. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
20. What is the penalty for a person who fails to provide information requested by the Authority?
21. The Central Research Fund fee collected by the Authority will be utilized for:
22. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
23. What type of containers are ophthalmic solutions and suspensions required to be contained in?
24. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
25. What is the purpose of Schedule-III of the DRAP Act?
26. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
27. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
28. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
29. In which circumstances may the Registration Board register a drug on its own motion?
30. What condition must be met for an application for renewal of a licence to be entertained?
31. Who is considered an "investigator" under the Drugs (Research) Rules?
32. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
33. What is the main duty of a Federal Inspector?
34. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
35. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
36. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
37. What kind of offense is non-cognizable under the Drugs Act 1976?
38. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
39. What is the maximum allowable retailer's discount for drugs?
40. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
41. What is the term of office for members of the Registration Board?
42. Which power of the Inspector requires specific authorization by the Government?
43. What is the purpose of Schedule-III of the DRAP Act?
44. What are "Medical Devices" under Schedule-I?
45. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
46. What is the short title of the rules that govern the Drugs Appellate Board?
47. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
48. Within what time frame should the Authority submit its annual report to the Federal Government?
49. What is the duration of a license to import drugs, unless suspended or canceled?
50. Under what condition can finished drugs be imported?
51. What is the purpose of the license to manufacture drugs for experimental purposes?
52. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
53. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
54. What is the penalty for a person who fails to provide information requested by the Authority?
55. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
56. What is the purpose of the criteria regarding medical representatives?
57. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
58. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
59. Who is responsible for maintaining records of quarterly production and disposal of a drug?
60. What is the Appellate Board's authority to call for the record of a case for review?
61. When does an Inspector need to divide a sample into three portoons instead of four?
62. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
63. Under what conditions is contract manufacture permissible?
64. How many members does the Policy Board consist of?
65. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
66. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
67. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
68. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
69. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
70. What is the role of the Quality Control Department in the manufacturing process?
71. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
72. Within what time frame should the Authority submit its annual report to the Federal Government?
73. What is the duration of a license to export drugs?
74. Which power of the Inspector requires specific authorization by the Government?
75. What is the primary purpose of the Committee of Experts on Drug Research?
76. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
77. What are the conditions that the Central Licensing Board must ensure are complied with before granting or renewing a licence to manufacture drugs by way of basic or semi-basic manufacture?
78. In what circumstances shall a drug not be deemed misbranded or adulterated?
79. What substances are NOT included in the definition of "Drug" under Schedule-I?
80. What is the fee for the renewal of registration of a new drug?
81. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
82. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
83. What is the role of the Quality Control Department in the manufacturing process?
84. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
85. The Authority may open its accounts with:
86. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
87. What does an Inspector require from a person during a search or seizure under Schedule-V?
88. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
89. Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?
90. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
91. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
92. What substances are NOT included in the definition of "Drug" under Schedule-I?
93. In which situations may the Registration Board provisionally register a drug for a period of two years?
94. What are "Medicated Cosmetics" under Schedule-I?
95. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
96. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
97. What is the purpose of 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976'?
98. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
99. Who serves as the ex-officio Chairman of the Appellate Board?
100. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
