1. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
2. What is the penalty for a person who fails to provide information requested by the Authority?
3. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
4. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
5. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
6. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
7. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
8. What kind of offense is non-cognizable under the Drugs Act 1976?
9. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
10. Who qualifies as a Federal Inspector according to these rules?
11. Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?
12. What is the purpose of Schedule-III of the DRAP Act?
13. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
14. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
15. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
16. 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?
17. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
18. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
19. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
20. What is the purpose of the criteria regarding medical representatives?
21. What does an Inspector require from a person during a search or seizure under Schedule-V?
22. What is the purpose of the Drugs (Research) Rules, 1978?
23. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
24. What is the purpose of Schedule-III of the DRAP Act?
25. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
26. Under what condition can finished drugs be imported?
27. What is the penalty for a person who fails to provide information requested by the Authority?
28. What is the purpose of the Committee on Drugs Evaluation?
29. Which type of research involves intervention, treatment, or medication programs using human subjects?
30. How many members does the Policy Board consist of?
31. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
32. In what circumstances shall a drug not be deemed misbranded or adulterated?
33. What is the primary purpose of the Committee of Experts on Drug Research?
34. Under what conditions are drug advertisements to the general public generally permitted?
35. What is the main duty of a Federal Inspector?
36. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
37. What is the fee for the renewal of registration of a new drug?
38. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
39. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
40. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
41. What is the Appellate Board's authority to call for the record of a case for review?
42. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
43. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
44. Which of the following is NOT a source of financing the Drug Regulatory Authority Fund?
45. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
46. Within what time frame should the Authority submit its annual report to the Federal Government?
47. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
48. What labeling requirements apply to drugs manufactured for experimental purposes?
49. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
50. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
51. What type of containers are ophthalmic solutions and suspensions required to be contained in?
52. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
53. The Central Research Fund fee collected by the Authority will be utilized for:
54. What is the duration of a license to import drugs, unless suspended or canceled?
55. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
56. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
57. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
58. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
59. What are "Medicated Cosmetics" under Schedule-I?
60. What action should the Authority take in response to objections raised by the Auditor-General?
61. 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?
62. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
63. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
64. What is the duration of a license to export drugs?
65. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
66. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
67. What substances are NOT included in the definition of "Drug" under Schedule-I?
68. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
69. Which of the following statements about advertisement material is NOT true?
70. Who is responsible for carrying out the audit of the Authority's accounts?
71. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
72. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
73. When can deviations be made from the information submitted during the registration of a drug?
74. What is the role of the Quality Control Department in the manufacturing process?
75. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
76. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
77. What is the purpose of an "airlock" in pharmaceutical manufacturing?
78. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
79. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
80. What does an Inspector require from a person during a search or seizure under Schedule-V?
81. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
82. What is the primary function of the Federal Drug Laboratory as stated in the rules?
83. Who is considered an "investigator" under the Drugs (Research) Rules?
84. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
85. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
86. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
87. What is the purpose of Form 6?
88. What is the purpose of Form 10 in the export of drugs?
89. What are "Medical Devices" under Schedule-I?
90. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
91. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
92. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
93. 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?
94. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
95. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
96. What are "Medicated Cosmetics" under Schedule-I?
97. What ethical criteria should be followed for medical drug promotion?
98. When does an Inspector need to divide a sample into three portoons instead of four?
99. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
100. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
