1. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
2. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
3. How many members does the Policy Board consist of?
4. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
5. When does an Inspector need to divide a sample into three portoons instead of four?
6. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
7. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
8. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
9. What does an Inspector require from a person during a search or seizure under Schedule-V?
10. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
11. What substances are NOT included in the definition of "Drug" under Schedule-I?
12. Within what time frame should the Authority submit its annual report to the Federal Government?
13. In which situations may the Registration Board provisionally register a drug for a period of two years?
14. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
15. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
16. What is the purpose of the license to manufacture drugs for experimental purposes?
17. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
18. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
19. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
20. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
21. Which of the following offenses punishable under Schedule-III is non-cognizable?
22. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
23. What labeling requirements apply to drugs manufactured for experimental purposes?
24. When does an Inspector need to divide a sample into three portoons instead of four?
25. What is the purpose of the Drugs (Research) Rules, 1978?
26. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
27. What substances are NOT included in the definition of "Drug" under Schedule-I?
28. What condition must be met for an application for renewal of a licence to be entertained?
29. What is the purpose of the criteria regarding medical representatives?
30. What is the duration of a license to export drugs?
31. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
32. What is the purpose of 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976'?
33. What is the primary function of the Federal Drug Laboratory as stated in the rules?
34. What must be included in the labelling and promotion of a registered drug?
35. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
36. What is the term of office for members of the Registration Board?
37. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
38. What are "Medical Devices" under Schedule-I?
39. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
40. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
41. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
42. What are "Medicated Cosmetics" under Schedule-I?
43. When can deviations be made from the information submitted during the registration of a drug?
44. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
45. For drugs other than those falling under specific categories, whose approval is required for the specifications?
46. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
47. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
48. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
49. In which circumstances may the Registration Board register a drug on its own motion?
50. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
51. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
52. What is the purpose of an "airlock" in pharmaceutical manufacturing?
53. Who qualifies as a Federal Inspector according to these rules?
54. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
55. What kind of offense is non-cognizable under the Drugs Act 1976?
56. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
57. What does the term "Advertise" mean under Schedule-II?
58. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
59. What are "Medical Devices" under Schedule-I?
60. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
61. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
62. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
63. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
64. Which of the following offenses punishable under Schedule-III is non-cognizable?
65. Within what time frame should the Authority submit its annual report to the Federal Government?
66. What is the purpose of an "airlock" in pharmaceutical manufacturing?
67. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
68. The Drugs Act, 1976 extends to which of the following areas?
69. 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?
70. What is the short title of the rules that govern the Drugs Appellate Board?
71. Which of the following is NOT considered as "Therapeutic goods" under the Act?
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. Who is responsible for maintaining records of quarterly production and disposal of a drug?
74. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
75. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
76. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
77. What is the purpose of Schedule-III of the DRAP Act?
78. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
79. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
80. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
81. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
82. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
83. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
84. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
85. What is the fee for the renewal of registration of a new drug?
86. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
87. What is the penalty for a person who fails to provide information requested by the Authority?
88. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
89. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
90. Which of the following statements about advertisement material is NOT true?
91. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
92. Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?
93. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
94. Which of the following criteria should promotional claims about drugs adhere to?
95. What does the term "batch number (or lot number)" refer to?
96. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
97. What is the purpose of Form 10 in the export of drugs?
98. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
99. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
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?
