1. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
2. Under what conditions are drug advertisements to the general public generally permitted?
3. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
4. What are "Medicated Cosmetics" under Schedule-I?
5. What does the term "Advertise" mean under Schedule-II?
6. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
7. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
8. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
9. What action should the Authority take in response to objections raised by the Auditor-General?
10. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
11. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
12. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
13. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
14. Which power of the Inspector requires specific authorization by the Government?
15. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
16. Which of the following statements about advertisement material is NOT true?
17. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
18. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
19. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
20. What is the purpose of Schedule-III of the DRAP Act?
21. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
22. What ethical criteria should be followed for medical drug promotion?
23. What type of containers are ophthalmic solutions and suspensions required to be contained in?
24. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
25. 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?
26. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
27. What is the purpose of the license to manufacture drugs for experimental purposes?
28. What does an Inspector require from a person during a search or seizure under Schedule-V?
29. What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?
30. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
31. What is the Appellate Board's authority to call for the record of a case for review?
32. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
33. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
34. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
35. What are "Medical Devices" under Schedule-I?
36. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
37. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
38. How many members does the Policy Board consist of?
39. What is the purpose of an "airlock" in pharmaceutical manufacturing?
40. In which circumstances may the Registration Board register a drug on its own motion?
41. What labeling requirements apply to drugs manufactured for experimental purposes?
42. What are "Medicated Cosmetics" under Schedule-I?
43. Which of the following is NOT a source of financing the Drug Regulatory Authority Fund?
44. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
45. Which of the following is NOT considered as "Therapeutic goods" under the Act?
46. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
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 primary focus of basic research in the context of the Drugs (Research) Rules?
49. What does the term "Advertise" mean under Schedule-II?
50. The Drugs Act, 1976 extends to which of the following areas?
51. What is the short title of the rules that govern the Drugs Appellate Board?
52. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
53. What is the role of the Quality Control Department in the manufacturing process?
54. What is the main duty of a Federal Inspector?
55. What is the fee for the renewal of registration of a new drug?
56. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
57. 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?
58. Which of the following offenses punishable under Schedule-III is non-cognizable?
59. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
60. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
61. What is the purpose of Form 10 in the export of drugs?
62. What is the commencement date for the Drugs (Specifications) Rules, 1978?
63. What is the role of the Quality Control Department in the manufacturing process?
64. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
65. 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?
66. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
67. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
68. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
69. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
70. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
71. What is the duration of a license to import drugs, unless suspended or canceled?
72. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
73. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
74. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
75. What is the primary purpose of the Committee of Experts on Drug Research?
76. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
77. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
78. 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?
79. The Central Research Fund fee collected by the Authority will be utilized for:
80. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
81. What substances are NOT included in the definition of "Drug" under Schedule-I?
82. For drugs other than those falling under specific categories, whose approval is required for the specifications?
83. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
84. What is the purpose of Schedule-III of the DRAP Act?
85. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
86. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
87. When can deviations be made from the information submitted during the registration of a drug?
88. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
89. What action should the Authority take in response to objections raised by the Auditor-General?
90. Within what time frame should the Authority submit its annual report to the Federal Government?
91. Which type of ophthalmic preparations is allowed to have a preservative?
92. Who is responsible for maintaining records of quarterly production and disposal of a drug?
93. Which power of the Inspector requires specific authorization by the Government?
94. Who is considered an "investigator" under the Drugs (Research) Rules?
95. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
96. 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?
97. What is the tenure of the CEO's appointment, and how many times can it be extended?
98. What must be included in the labelling and promotion of a registered drug?
99. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
100. What does an Inspector require from a person during a search or seizure under Schedule-V?
