DRAP Preparation Mock Exam 3

DRAP Mock Exam 3 (Forensic Pharmacy)

Subject: Forensic Pharmacy

- - - Questions Type: Multiple Choice Questions (MCQs)
    - Total number of questions: 80
    - Total number of pages: 2 (each contain 50 questions)
    - Total time: 1hr & 20min
    - All questions carry equal marks.
    - There is no negative marking.
    - Result: After test submission you can see your score and the number of questions attempted and all the questions with their correct answers.

Syllabus:

The Alternative Medicines and health Products (Enlistment) Rules, 2014

The Medical Devices Rules, 2017

The Bio Study Rules, 2017

The Pharmacovigilance Rules, 2022

Control of Narcotic Substances Act, 1997

UN Conventions on Controlled Substances

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What is the purpose of the "Enlistment Certificate" mentioned in the rules?

It certifies the authenticity of herbal substances.

It provides guidelines for conducting clinical trials.

It grants temporary manufacturing and marketing authorization.

It outlines the manufacturing process for alternative medicines.

What is the definition of "Adulterated alternative medicine or health product"?

Medicines or health products that contain only herbal substances.

Medicines or health products with chemically defined synthetic ingredients

Medicines or health products that have been prepared under unsanitary conditions.

Medicines or health products that are used exclusively for therapeutic purposes.

Which term refers to a "noxious and unintended response to a product"?

Alternative Medicine

Adverse Reaction

Acceptance Criteria

Adulterated Medicine

What is the primary responsibility of the "Contract Acceptor" in the contract manufacturing process?

To evaluate the quality of the finished product.

To purchase materials for manufacturing.

To conduct clinical trials on the finished product.

To provide necessary information to the Contract Giver.

What does the term "herbal teas" in the rules refer to?

Teas made from chemically synthesized ingredients.

Teas made from homeopathic ingredients.

Teas made from plant extracts and herbal substances

Teas made exclusively from animal-derived ingredients

What does the term "mother tincture or tincture" refer to in the context of homeopathy?

The most diluted form of a homeopathic medicine

The initial homeopathic preparation made from source material

A highly potentized homeopathic remedy

A combination of different homeopathic medicines

What is the purpose of a "master formula" in the production of medicines and health products?

It specifies the recommended conditions of use for the product

It defines the safety guidelines for homeopathic medicines

It outlines the steps and precautions for manufacturing a specific quantity of the product

It indicates the potential therapeutic benefits of the product

What is the main focus of "quality control" in the manufacturing of alternative medicines and health products?

Ensuring the product's effectiveness and therapeutic claims

Monitoring the production environment and facilities

Assessing the nutritional content of the product

Verifying that products meet specified quality standards

What does the term "structured-function claim" refer to?

A claim that describes the intended purpose of the product

A claim related to the safety and quality of the product

A claim that highlights the product's compliance with GMP

A claim that describes the effect of the product on a physiological function

10.

What is the purpose of "validation" in the context of manufacturing medicines and health products?

Demonstrating the effectiveness of the product's therapeutic claims

Confirming the safety of the product for consumption

Proving that a procedure or process yields the expected results

Testing the product's compatibility with various packaging materials

11.

According to the Alternative Medicine Rules, which of the following is eligible to apply for enlistment?

Manufacturers with no manufacturing and quality control facilities

Importers without authorization from overseas principal manufacturers

Manufacturers without a manufacturing license under the Act

Manufacturers holding manufacturing licenses but not for alternative medicines

12.

What type of evidence must applicants submit during the application evaluation process?

Financial statements

Evidence of political connections

Evidence of safety concerns from international bodies

Evidence for quality, safety, efficacy, and recommended conditions for use

13.

Which committee is responsible for evaluating applications for enlistment of alternative medicines and health products?

Committee for Medicinal Plant Research

Committee for International Trade Regulations

Enlistment Evaluation Committee

Committee for Traditional Medicine Development

14.

What does the "Enlistment Certificate" issued by the Authority allow the holder to do?

It confers the right for unlimited continuation of manufacturing and import.

It grants manufacturing licenses for any type of medicine or health product

It allows the holder to market products globally

It authorizes the holder to procure raw materials and market products within Pakistan.

15.

What does the term "GMP" stand for in the context of the provided text?

Good Medical Practice

General Manufacturing Protocol

Good Manufacturing Practices

General Medicinal Procedures

16.

What is the purpose of an "accessory" in the context of medical devices?

It is a medical device designed for self-testing purposes.

It is a medical device that supports the functioning of another medical device.

It is a medical device specifically intended for surgical procedures.

It is a medical device that is implanted within the human body.

17.

What does the term "active device intended for diagnosis" refer to?

A medical device that augments or extends the capabilities of another device

It is a medical device that supports the functioning of another medical device.

A medical device that operates based on energy generated by the human body.

A medical device used for treatment purposes in a clinical environment.

18.

Which of the following is NOT considered an "active medical device"?

A medical device that operates using electrical energy

A medical device that converts energy from a source other than the human body

A medical device used for transmitting energy between devices and patients.

A medical device used for detecting physiological conditions

19.

What is the definition of an "implantable medical device"?

A medical device that is intended for short-term use.

A medical device used for diagnostic purposes.

A medical device designed for surgical procedures

A medical device that is intended to remain in the body after surgical intervention.

20.

What does the term "objective evidence" mean in the context of medical devices?

Data collected through clinical investigations

Verifiable information related to the quality of a medical device.

The manufacturer's intended use for a medical device

Scientific literature supporting the safety of a medical device.

21.

What are the two main types of establishment licences issued by the MDB under Chapter II of the Medical Device Rules 2017?

Licence to manufacture pharmaceuticals and licence to distribute medical devices.

Licence to manufacture medical devices and licence to import medical devices.

Licence to distribute medical devices and licence to export medical devices.

Licence to research medical devices and licence to market medical devices.

22.

What is the maximum duration of validity for an establishment licence granted under the Medical Device Rules 2017?

1 year

3 years

5 years

10 years

23.

Which of the following is NOT a condition for granting an establishment licence to manufacture medical devices?

Having a quality control department with adequate laboratory equipment.

Providing facilities for vaccinaFon and inoculation against diseases.

Complying with good manufacturing practices (GMP).

Maintaining sufficient quantity of samples of imported medical devices.

24.

If an application for renewal of an establishment licence is made after one year of its expiry, what additional action is required by the establishment?

The establishment must pay a reduced renewal fee.

The establishment must provide an explanation for the delay in renewal.

The establishment must deposit an additional fee equivalent to the applicable renewal fee for each month.

The establishment can renew the licence without any additional requirements.

25.

Under what circumstances can the MDB cancel or suspend an establishment licence?

If the establishment changes its premises

If the establishment changes the type of medical devices it manufactures.

If the establishment is not compliant with good manufacturing practices.

If the establishment applies for renewal after the expiry of the licence.

26.

Which of the following is NOT one of the specific medical purposes for which medical devices are intended, as outlined in the Medical Devices Rules 2017?

Providing information through in-vitro examination.

Preventing psychological disorders.

Supporting or sustaining life.

Controlling conception.

27.

What is the minimum validity period for the enlistment or registration of a medical device under the Medical Devices Rules 2017?

1 year

2 years

3 years

5 years

28.

What action may the MDB take if a medical device's enlistment or registration holder fails to comply with the conditions of enlistment or registration?

Levy a fine on the establishment.

Cancel or suspend the enlistment or registration.

Issue a warning letter.

Increase the application fee for renewal.

29.

Which regulatory authorities' approvals may be considered as a basis for medical device enlistment or registration in Pakistan, according to the Medical Devices Rules 2017?

Regulatory authorities of any Asian country.

Regulatory authorities of USA, Canada, and Australia only

Regulatory authorities of European Union countries only.

Regulatory authorities of specified countries including USA, Japan, Australia, and European Union countries.

30.

Under what conditons can an importer import a medical device according to the Medical Device Rules 2017?

Possession of a valid medical device license only

Possession of a valid medical device enlistment only.

Possession of valid premises for proper storage only.

Possession of valid medical device establishment license and medical device enlistment or registration.

31.

According to Chapter III of the Medical Devices Rules 2017, what is the purpose of classification and grouping of medical devices?

To determine the market price of medical devices.

To establish ownership of medical devices.

To guide medical device manufacturing procedures.

For the purpose of registration and enlistment.

32.

What is the purpose of obtaining an import permit for small quantities of medical devices for clinical investigation or analysis?

To allow free import of medical devices without any restrictions

To allow personal use of medical devices without any regulatory oversight.

To facilitate the import of medical devices for commercial distribution.

To import medical devices for the purpose of clinical investigation, examination, test, or analysis.

33.

What is the maximum duration of validity for an export permit for medical devices under the Medical Device Rules 2017?

1 year

2 years

3 years

5 years

34.

In what situations can the Medical Devices Board (MDB) cancel or suspend an export permit?

If the exporter fails to submit proper documentation.

If the exporter wants to change the destination country.

If the medical devices are intended for personal use.

If the exporter violates any condition of the export permit or the rules.

35.

What documents are required to accompany consignments of medical devices for export under the Medical Device Rules 2017?

Manufacturer's name and address only.

Certificate of analysis for each batch or lot only

Undertaking regarding the genuineness of documents only

Invoice or statement, certificate of analysis, and an undertaking on quality and safety

36.

According to Chapter VI of the Medical Devices Rules 2017, which of the following is a requirement for the label of a medical device?

It should be written in the official language of the country

It should include the physical appearance of the manufacturer's CEO.

It should contain a detailed list of ingredients.

It should include information about establishment-licence details, enlistment or registration number, and MRP.

37.

Where should the label of a medical device be located, according to the rules?

Inside the packaging of the device.

Attached to the medical device user manual.

Provided as a separate leaflet inside the packaging

It depends on the type of medical device and its intended use.

38.

What is the primary language used for labelling of medical devices?

The local language of the country where the device is marketed.

The manufacturer's preferred language.

English and Urdu for home-used medical devices.

The language spoken by the majority of the population.

39.

Which of the following should be included in the label of a medical device, as specified in the rules?

Manufacturer's email address.

The device's primary color.

Expiry date of the label.

Maximum retail price (MRP), date of manufacturing, and technical details of the device.

40.

In addition to general contents, what other specific contents might be required on the label of a medical device?

A list of all previous users of the device.

A detailed map of the device's manufacturing facility.

Instructions for using the device as a musical instrument.

Information about sterilization, precautions, and re-sterilization methods if the packaging is damaged.

41.

For how long is the exemption from the operation of the rules applicable for Class C medical devices?

6 months

9 months

12 months

18 months

42.

Which category of medical devices requires an application for provisional establishment certificate?

Class A medical devices

Class B medical devices

Class C medical devices

Class D medical devices

43.

What is the consequence for contravening the rules related to fabrication of custom-made medical devices?

Suspension of the establishment's license

Exemption from the operation of the rules

Fine

Cancellation of the provisional establishment certificate

44.

What is the requirement for a person using or operating a medical device in a healthcare facility?

Training by the manufacturer or authorized representative

Completion of a medical degree

Approval from the Ministry of Health

Ownership of the medical device

45.

Who is responsible for the enlistment or registration of medical devices, licensing of establishments, and issuance of permits for export and import of medical devices according to the Medical Devices Rules 2017?

Director General Health

Director, Medical Devices and Medicated Cosmetics

Additional Director, Medical Devices and Medicated Cosmetics

Chairman of the Appellate Board

46.

Which of the following individuals is NOT a member of the Medical Device Board (MDB) according to the rules?

Hospital Pharmacist

Cardiovascular Surgeon

Hospital Administrator

Biomedical Engineer

47.

If a medical device is declared unsafe and sub-standard by a notified laboratory, what action can the MDB take?

Issue a warning to the establishment

Issue a recall nottce for withdrawal of stock

Impose a fine on the manufacturer

Restrict the import of similar medical devices

48.

In case of a decision by the MDB that an aggrieved party wishes to appeal, to which board should the appeal be made?

Medical Device Board (MDB)

Quality Control Laboratory

Appellate Board of the Authority

Policy Board of the Authority

49.

The quorum required to conduct a meeting of the Medical Device Board (MDB) is:

One-third of the total members

Two-thirds of the total members

One-half of the total members

All members must be present

50.

Who can require samples of enlisted or registered medical devices for testing?

Manufacturer

Healthcare facility

Medical Devices Board

Importer

51.

According to Medical Devices Rules, rule 63(1), the fee specified in Schedule C is payable for which of the following activities?

Enlistment or registration of medical devices

Import and export of medical devices

Licensing of healthcare facilities

Advertising medical devices

52.

Who has the authority to amend Schedule C of the Medical Devices Rules?

Medical Device Board (MDB)

Director General of Health

Drug Regulatory Authority of Pakistan

Policy Board of the Authority

53.

What is the validity period of the approval of medical device advertisement?

1 year

2 years

3 years

6 months

54.

According to rule 67(1)(a), which regulatory authorities' approval of a medical device would allow outsourcing of its manufacturing?

Regulatory authorities of African countries

Regulatory authorities of Asian countries

Regulatory authorities of European countries

Regulatory authorities of South American countries

55.

According to rule 69, the fee deposited for any activity specified in rule 63 of Medical Devices Rules is:

Refundable upon request

Refundable if the application is rejected

Non-refundable

Refundable with a processing fee

56.

What is the scope of the Bio-study Rules, 2017?

They apply to clinical trials of therapeutic goods only.

They apply to clinical trials of therapeutic goods and bio-availability studies only.

They apply to clinical trials of therapeutic goods, bio-availability studies, and bioequivalence studies on human subjects.

They apply to clinical trials of therapeutic goods, bio-availability studies, and bioequivalence studies on animals.

57.

What does "bio-equivalence" or "BE" mean according to these rules?

The bioavailability of a drug in different formulations.

The measurement of the therapeuic activity of a drug.

The equivalence of two medicinal products containing the same active ingredient and formulation.

The rate of absorption of a drug in the body.

58.

What is the purpose of an "independent ethics commiSee" or "IEC"?

To conduct bio-availability studies.

To ensure compliance with good clinical practice guidelines.

To verify the clinical efficacy of investigational products.

To review and approve clinical trial protocols and protect the rights and safety of human subjects.

59.

What is the duration of a license issued under the Biostudy rules?

1 year

2 years

3 years

5 years

60.

What does "GCP" stand for in the context of the Biostudy rules?

General Clinical Procedures

Good Clinical Practice

General Clinical Protocols

Good Clinical Principles

61.

Which committee must applicants seek prior approval from to conduct clinical trials or studies?

Central Drug Authority

National Drug Regulatory Authority

Independent Ethics Commttee (IRB)

International Clinical Trials Committee

62.

How many members should the Independent Ethics Committee (IRB) consist of?

At least three members

At least five members

At least seven members

At least ten members

63.

What type of members should be included in the IRB, according to the rules?

Only scientific experts

Only non-scientific experts

A mix of scientific and non-scientific experts

Only medical practitioners

64.

What type of labeling is required for investigational products intended for human use?

"For investigational use only"

"Safe and effective for all purposes"

"Approved for sale"

"For public use"

65.

What function does the Clinical Studies CommiSee (CSC) perform?

Conduct clinical trials and studies

Issue licenses for clinical trials

Review and evaluate applications for licenses and approvals

Maintain the clinical trial registry

66.

What is the primary purpose of the National Pharmacovigilance Centre (NPC) established under the Pharmacovigilance Rules, 2022?

To manufacture therapeutic goods

To regulate drug prices

To execute pharmacovigilance activities and coordinate at various levels

To provide medical treatment

67.

What is the definition of "adverse drug reaction" or "ADR" as per the Pharmacovigilance Rules?

Any untoward medical occurrence in a patient unrelated to drug usage

Any beneficial medical occurrence in a patient related to drug usage

Any moderate side effect experienced by a patient during drug usage

Any harmful and unintended response to a drug used for disease prevention

68.

What does "active surveillance" refer to in the context of pharmacovigilance?

Monitoring for therapeutic goods' expiration dates

Routine patient check-ups after drug administration

Enhanced or targeted monitoring of adverse events through a continuous process

Reporting of healthcare professional errors related to drug administration

69.

What is the primary purpose of a "periodic benefit-risk evaluation report" (PBRER) as defined in the Pharmacovigilance Rules?

To provide advertising material for therapeutic goods

To update the list of approved indications for a therapeutic good

To assess and analyze new information on the risks and benefits of a therapeutic good

To evaluate the effectiveness of marketing campaigns for therapeutic goods

70.

Which of the following situations is considered an "unexpected adverse reaction" as per the Pharmacovigilance Rules?

A known side effect of a drug occurring at a higher than expected frequency

A side effect of a drug that is consistent with its registered therapeutic information

A side effect of a drug that is anticipated and listed in the product information

An adverse reaction that is inconsistent with the drug's registered labeling or characteristics

71.

What is the primary responsibility of a Pharmacovigilance Officer (PO) at the level of a secondary and tertiary care public sector hospital?

Coordinate with NPC and public and private sector hospitals

Conduct pharmacoepidemiological studies and cohort event monitoring

Issue therapeutic goods safety alerts within the province

Collect pharmacovigilance data from therapeutic goods sale points

72.

Which committee is responsible for performing functions related to risk management associated with the use of therapeutic goods, including signal detection, risk minimization, and evaluation of periodic reports?

National Pharmacovigilance Centre (NPC)

Provincial Pharmacovigilance Committee (PPC)

Expert Safety Review Panel (ESRP)

Pharmacovigilance Risk Assessment Expert Committee (PRAEC)

73.

What is the responsibility of the Qualified Person for Pharmacovigilance (QPPV) appointed by the registration holder?

Monitor all medical literature and report AEs within 30 calendar days

Establish procedures for signal detection and assessment of reports

Collect pharmacovigilance data from public and private sector hospitals

Coordinate with the Pharmacovigilance Risk Assessment Expert CommiWee (PRAEC)

74.

What is the purpose of the Pharmacovigilance System Master File (PSMF) maintained by a registration holder?

To record all adverse events and reactions

To provide information to the Qualified Person for Pharmacovigilance (QPPV)

To submit to the National Pharmacovigilance Centre (NPC) on a monthly basis

To establish procedures for obtaining accurate and verifiable data

75.

When should the registration holder submit a Periodic Benefit-Risk Evaluation Report (PBRER) for generic drugs, drugs with well-established use, and alternative medicines?

Within 30 calendar days of awareness

Every six months after registration

Only if directed by the PRAEC

Only if new risks are detected

76.

What is the primary purpose of the Control of Narcotic Substances Act, 1997?

To regulate the import and export of narcotics for medical purposes

To control the manufacturing and distribution of controlled substances

To legalize the possession and consumption of narcotics

To promote the cultivation of narcotic plants for industrial use

77.

Who is considered an "addict" under the Control of Narcotic Substances Act, 1997?

Any person using narcotics occasionally

Any person who habitually uses narcotic drugs or psychotropic substances

Any person involved in the culyivation of opium poppy

Any person physically fit and not dependent on narcotics

78.

What is the definition of "controlled delivery" under the Act?

The controlled distribution of narcotics within Pakistan

The legal sale of controlled substances under strict supervision

A technique involving the movement of illicit consignments under government supervision to identify offenders

A process of quality control for manufactured drugs

79.

What is the meaning of "psychotropic substance" as defined in the Act?

Substances used for enhancing physical strength

Substances causing temporary amnesia

Substances that alter mental processes, emotions, and perception

Substances used for inducing deep sleep

80.

According to the Act, what is the role of the "Special Court"?

To oversee the operations of pharmaceutical companies

To regulate the cultivation of medicinal hemp

To handle cases related to offenses under the Act

To promote international conventions related to narcotics

DRAP Preparation Mock Exam 3

DRAP Mock Exam 3 (Forensic Pharmacy)

Subject: Forensic Pharmacy

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