1. What is the duration of a license to export drugs?
2. What is the purpose of the criteria regarding medical representatives?
3. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
4. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
5. What is the commencement date for the Drugs (Specifications) Rules, 1978?
6. What type of containers are ophthalmic solutions and suspensions required to be contained in?
7. What is the purpose of Schedule-III of the DRAP Act?
8. What is the purpose of Form 10 in the export of drugs?
9. When does an Inspector need to divide a sample into three portoons instead of four?
10. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
11. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
12. The Central Research Fund fee collected by the Authority will be utilized for:
13. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
14. What are "Medical Devices" under Schedule-I?
15. What is the term of office for members of the Registration Board?
16. Within what time frame should the Authority submit its annual report to the Federal Government?
17. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
18. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
19. Who is responsible for maintaining records of quarterly production and disposal of a drug?
20. In what circumstances shall a drug not be deemed misbranded or adulterated?
21. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
22. What is the Appellate Board's authority to call for the record of a case for review?
23. What are "Medical Devices" under Schedule-I?
24. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
25. In which situations may the Registration Board provisionally register a drug for a period of two years?
26. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
27. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
28. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
29. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
30. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
31. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
32. Under what conditions is contract manufacture permissible?
33. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
34. What ethical criteria should be followed for medical drug promotion?
35. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
36. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
37. In which circumstances may the Registration Board register a drug on its own motion?
38. What is the purpose of Schedule-III of the DRAP Act?
39. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
40. 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?
41. What is the short title of the rules that govern the Drugs Appellate Board?
42. What does the term "Advertise" mean under Schedule-II?
43. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
44. What is the role of the Quality Control Department in the manufacturing process?
45. What is the purpose of Form 6?
46. Which type of ophthalmic preparations is allowed to have a preservative?
47. What is the penalty for a person who fails to provide information requested by the Authority?
48. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
49. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
50. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
51. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
52. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
53. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
54. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
55. Which of the following is NOT considered as "Therapeutic goods" under the Act?
56. What is the primary function of the Federal Drug Laboratory as stated in the rules?
57. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
58. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
59. The Authority shall levy and collect fees for its functions at rates determined by:
60. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
61. Which power of the Inspector requires specific authorization by the Government?
62. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
63. Who is responsible for carrying out the audit of the Authority's accounts?
64. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
65. What is the purpose of 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976'?
66. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
67. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
68. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
69. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
70. What is the penalty for a person who fails to provide information requested by the Authority?
71. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
72. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
73. 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?
74. What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?
75. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
76. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
77. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
78. What condition must be met for an application for renewal of a licence to be entertained?
79. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
80. What action should the Authority take in response to objections raised by the Auditor-General?
81. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
82. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
83. What does the term "batch number (or lot number)" refer to?
84. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
85. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
86. What is the purpose of an "airlock" in pharmaceutical manufacturing?
87. How many members does the Policy Board consist of?
88. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
89. Who is considered an "investigator" under the Drugs (Research) Rules?
90. Which of the following offenses punishable under Schedule-III is non-cognizable?
91. Which of the following criteria should promotional claims about drugs adhere to?
92. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
93. What is the fee for the renewal of registration of a new drug?
94. The Drugs Act, 1976 extends to which of the following areas?
95. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
96. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
97. What substances are NOT included in the definition of "Drug" under Schedule-I?
98. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
99. 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?
100. What is the tenure of the CEO's appointment, and how many times can it be extended?
