1. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
2. Within what time frame should the Authority submit its annual report to the Federal Government?
3. 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?
4. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
5. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
6. What substances are NOT included in the definition of "Drug" under Schedule-I?
7. Which of the following offenses punishable under Schedule-III is non-cognizable?
8. Who is responsible for carrying out the audit of the Authority's accounts?
9. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
10. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
11. Which of the following statements about advertisement material is NOT true?
12. What type of containers are ophthalmic solutions and suspensions required to be contained in?
13. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
14. What is the purpose of the criteria regarding medical representatives?
15. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
16. What condition must be met for an application for renewal of a licence to be entertained?
17. Which type of research involves intervention, treatment, or medication programs using human subjects?
18. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
19. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
20. What is the purpose of Schedule-III of the DRAP Act?
21. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
22. Which power of the Inspector requires specific authorization by the Government?
23. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
24. When does an Inspector need to divide a sample into three portoons instead of four?
25. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
26. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
27. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
28. In which circumstances may the Registration Board register a drug on its own motion?
29. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
30. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
31. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
32. What is the penalty for a person who fails to provide information requested by the Authority?
33. What does the term "Advertise" mean under Schedule-II?
34. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
35. The Drugs Act, 1976 extends to which of the following areas?
36. What is the term of office for members of the Registration Board?
37. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
38. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
39. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
40. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
41. What is the primary purpose of the Committee of Experts on Drug Research?
42. Which power of the Inspector requires specific authorization by the Government?
43. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
44. Under what conditions are drug advertisements to the general public generally permitted?
45. What is the purpose of 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976'?
46. What kind of offense is non-cognizable under the Drugs Act 1976?
47. What is the purpose of the Drugs (Research) Rules, 1978?
48. What is the short title of the rules that govern the Drugs Appellate Board?
49. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
50. What is the fee for the renewal of registration of a new drug?
51. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
52. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
53. What substances are NOT included in the definition of "Drug" under Schedule-I?
54. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
55. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
56. What labeling requirements apply to drugs manufactured for experimental purposes?
57. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
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. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
60. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
61. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
62. 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?
63. What is the maximum allowable retailer's discount for drugs?
64. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
65. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
66. Who is considered an "investigator" under the Drugs (Research) Rules?
67. What action should the Authority take in response to objections raised by the Auditor-General?
68. What is the role of the Quality Control Department in the manufacturing process?
69. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
70. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
71. Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?
72. In case of an appeal against the decision of the Registration Board rejecting an application for registration of a drug, what statement is required to be submitted?
73. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
74. Who qualifies as a Federal Inspector according to these rules?
75. The Central Research Fund fee collected by the Authority will be utilized for:
76. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
77. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
78. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
79. What is the purpose of the Committee on Drugs Evaluation?
80. What is the penalty for a person who fails to provide information requested by the Authority?
81. What does an Inspector require from a person during a search or seizure under Schedule-V?
82. What is the role of the Quality Control Department in the manufacturing process?
83. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
84. What is the Appellate Board's authority to call for the record of a case for review?
85. Who may physically inspect an imported consignment, draw samples, and order the importer not to sell or dispose of the drug for a specific period?
86. What is the purpose of the license to manufacture drugs for experimental purposes?
87. What are "Medicated Cosmetics" under Schedule-I?
88. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
89. Under what conditions is contract manufacture permissible?
90. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
91. In what circumstances shall a drug not be deemed misbranded or adulterated?
92. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
93. What is the main duty of a Federal Inspector?
94. When can deviations be made from the information submitted during the registration of a drug?
95. 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?
96. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
97. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
98. What is the commencement date for the Drugs (Specifications) Rules, 1978?
99. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
100. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
