1. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
2. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
3. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
4. What does the term "batch number (or lot number)" refer to?
5. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
6. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
7. What kind of offense is non-cognizable under the Drugs Act 1976?
8. Within what time frame should the Authority submit its annual report to the Federal Government?
9. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
10. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
11. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
12. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
13. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
14. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
15. What are "Medical Devices" under Schedule-I?
16. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
17. What is the term of office for members of the Registration Board?
18. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
19. What condition must be met for an application for renewal of a licence to be entertained?
20. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
21. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
22. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
23. What does an Inspector require from a person during a search or seizure under Schedule-V?
24. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
25. What is the Appellate Board's authority to call for the record of a case for review?
26. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
27. Which type of research involves intervention, treatment, or medication programs using human subjects?
28. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
29. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
30. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
31. Which of the following statements about advertisement material is NOT true?
32. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
33. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
34. What are "Medicated Cosmetics" under Schedule-I?
35. What is the primary purpose of the Committee of Experts on Drug Research?
36. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
37. What does an Inspector require from a person during a search or seizure under Schedule-V?
38. What is the purpose of the license to manufacture drugs for experimental purposes?
39. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
40. Who is responsible for carrying out the audit of the Authority's accounts?
41. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
42. How many members does the Policy Board consist of?
43. What is the main duty of a Federal Inspector?
44. For drugs other than those falling under specific categories, whose approval is required for the specifications?
45. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
46. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
47. What is the purpose of Form 6?
48. What is the tenure of the CEO's appointment, and how many times can it be extended?
49. The Central Research Fund fee collected by the Authority will be utilized for:
50. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
51. What does the term "Advertise" mean under Schedule-II?
52. What is the purpose of an "airlock" in pharmaceutical manufacturing?
53. In what circumstances shall a drug not be deemed misbranded or adulterated?
54. Which type of ophthalmic preparations is allowed to have a preservative?
55. What does the term "Advertise" mean under Schedule-II?
56. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
57. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
58. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
59. Which power of the Inspector requires specific authorization by the Government?
60. What is the fee for the renewal of registration of a new drug?
61. What is the purpose of the Committee on Drugs Evaluation?
62. When does an Inspector need to divide a sample into three portoons instead of four?
63. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
64. What is the purpose of Schedule-III of the DRAP Act?
65. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
66. What must be included in the labelling and promotion of a registered drug?
67. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
68. Who qualifies as a Federal Inspector according to these rules?
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 penalty for a person who fails to provide information requested by the Authority?
71. Who is considered an "investigator" under the Drugs (Research) Rules?
72. Which of the following criteria should promotional claims about drugs adhere to?
73. What is the role of the Quality Control Department in the manufacturing process?
74. In which circumstances may the Registration Board register a drug on its own motion?
75. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
76. What type of containers are ophthalmic solutions and suspensions required to be contained in?
77. 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?
78. What substances are NOT included in the definition of "Drug" under Schedule-I?
79. What is the penalty for a person who fails to provide information requested by the Authority?
80. The Authority may open its accounts with:
81. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
82. Which of the following offenses punishable under Schedule-III is non-cognizable?
83. What action should the Authority take in response to objections raised by the Auditor-General?
84. What is the commencement date for the Drugs (Specifications) Rules, 1978?
85. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
86. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
87. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
88. Which power of the Inspector requires specific authorization by the Government?
89. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
90. What is the purpose of the criteria regarding medical representatives?
91. What substances are NOT included in the definition of "Drug" under Schedule-I?
92. What are "Medical Devices" under Schedule-I?
93. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
94. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
95. What is the duration of a license to export drugs?
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 purpose of Schedule-III of the DRAP Act?
98. What is the short title of the rules that govern the Drugs Appellate Board?
99. What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?
100. 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?
