Pharmacy Laws and Regulatory Authorities in Malaysia
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Questions and Answers

Which body is responsible for regulating the pharmacy sector in Malaysia?

  • National Pharmaceutical Regulatory Agency (correct)
  • Poison Board
  • Pharmacy Board
  • Medicine Advertisement Board

What type of products are involved in the pharmacy business product flow in Malaysia?

  • Prescription medicines (correct)
  • Electronics
  • Cosmetics
  • Clothing

Which law governs the pharmacy profession and practice in Malaysia?

  • Dangerous Drugs Act
  • Poisons Act
  • Registration of Pharmacist Act (correct)
  • Sale of Drugs Act

What is the main focus of the page about setting up a community pharmacy or a pharmaceutical company in Malaysia?

<p>Registration and approval processes (B)</p> Signup and view all the answers

Which authority is responsible for controlling the advertisement of medicines in Malaysia?

<p>Medicine Advertisement Board (D)</p> Signup and view all the answers

What type of drugs does the Dangerous Drugs Act govern in Malaysia?

<p>Prescription drugs (B)</p> Signup and view all the answers

What is the main purpose of the Sale of Drug Act 1952 (Act 368) in Malaysia?

<p>Regulating the sale of pharmaceutical products to the general public (C)</p> Signup and view all the answers

What is the role of the Medicine Advertisement Board (MAB) in Malaysia?

<p>Approving and regulating the advertisement of medicines (D)</p> Signup and view all the answers

Which entity is responsible for classifying new chemicals as poison in Malaysia?

<p>National Pharmaceutical Regulatory Agency (NPRA) (D)</p> Signup and view all the answers

In Malaysia, which type of company is required to have its shares offered to the public for fixed periods?

<p>Public Limited Company (C)</p> Signup and view all the answers

What is the primary focus of the Pharmacy Business Product Flow in Malaysia?

<p>Wholesale distribution of pharmaceutical products (D)</p> Signup and view all the answers

Under which act is the regulation of drug and cosmetics covered in Malaysia?

<p>Control of Drug and Cosmetics Regulation 1984 (C)</p> Signup and view all the answers

What is the primary purpose of the Pharmacy Act 1942 in Malaysia?

<p>Regulating the sale of poisons by retail (D)</p> Signup and view all the answers

Under the Poisons Act 1952 in Malaysia, who is allowed to sell poison by wholesale?

<p>Licensed wholesaler according to the Act (B)</p> Signup and view all the answers

What is the restriction on the sale of Group A poison in Malaysia?

<p>Can only be sold by licensed individuals or companies (B)</p> Signup and view all the answers

Who is permitted to supply poison for the purpose of treatment in Malaysia?

<p>Only registered medical practitioners (B)</p> Signup and view all the answers

What is the main focus of the Companies Commission of Malaysia (SSM)?

<p>Setting up pharmaceutical companies (D)</p> Signup and view all the answers

Who is responsible for controlling the sale of poisons by retail in Malaysia?

<p>Local authorities (D)</p> Signup and view all the answers

What level of government is responsible for approving the setting up of pharmaceutical companies in Malaysia?

<p>State government (D)</p> Signup and view all the answers

Who is authorized to sell poisons by wholesale according to the text?

<p>(licensed wholesaler according to the Act) (C)</p> Signup and view all the answers

Who can apply for tax incentives for pharmaceutical companies in Malaysia?

<p>(Malaysia Investment Development Authority (MIDA)) (A)</p> Signup and view all the answers

What is the role of the Medicine Advertisement Board (MAB) in Malaysia according to the given text?

<p>Controlling the advertisement of medicines (A)</p> Signup and view all the answers

What is the primary purpose of the Dangerous Drug Act 1952 and regulation (Act 234) in Malaysia?

<p>Regulating the sale of dangerous drugs (C)</p> Signup and view all the answers

What is the role of the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia?

<p>Regulate pharmaceutical product in Malaysia (A)</p> Signup and view all the answers

Under which act is the control of drug and cosmetics regulation covered in Malaysia?

<p>Control of Drug and Cosmetics Regulation 1984 (D)</p> Signup and view all the answers

What level of government is responsible for approving the setting up of pharmaceutical companies in Malaysia?

<p>Federal government (D)</p> Signup and view all the answers

What type of company is required to have its shares offered to the public for fixed periods in Malaysia?

<p>Public limited company (B)</p> Signup and view all the answers

What is the main focus of the Pharmacy Business Product Flow in Malaysia?

<p>Implant quality control of pharmaceutical products (C)</p> Signup and view all the answers

What is the primary purpose of the Pharmacy Act 1952 and regulation (Act 371) in Malaysia?

<p>Regulate pharmacy profession in Malaysia (B)</p> Signup and view all the answers

Who is responsible for controlling the advertisement of medicines in Malaysia?

<p>Medicine Advertisement Board (MAB) (B)</p> Signup and view all the answers

What is the main purpose of the Sale of Drug Act 1952 (Act 368) in Malaysia?

<p>Regulate the sale of drugs in Malaysia (A)</p> Signup and view all the answers

What type of products are involved in the Pharmacy Business Product Flow in Malaysia?

<p>All pharmaceutical products including traditional medicines (D)</p> Signup and view all the answers

Flashcards

Pharmacy Board Malaysia

The regulatory body responsible for overseeing the pharmacy sector in Malaysia, ensuring compliance with rules and regulations.

Pharmacy Business Product Flow

This flow encompasses a wide range of products, including pharmaceutical medications, cosmetics, and substances classified as poisons.

Pharmacy Act 1952

The foundation for pharmacy practices in Malaysia, setting standards and guidelines for pharmacists.

Setting Up a Pharmacy or Pharmaceutical Company

The key step for anyone looking to establish a pharmacy or a pharmaceutical company in Malaysia is obtaining the necessary approvals and licenses.

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Medicine Advertisement Board (MAB)

The body in charge of overseeing how medicines are advertised, ensuring that advertisements follow regulations and ethical standards.

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Dangerous Drugs Act 1952

The Act outlining rules and regulations for the handling of dangerous drugs, like opioids and controlled substances.

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Sale of Drug Act 1952

This act governs the legal sale and distribution of drugs, ensuring safe practices and controlled access.

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Poisons Act 1952

This act governs the management of poisons, including their sale, storage, and use.

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Wholesale Poison Sales

Only authorized companies can sell poisons in bulk, ensuring proper management.

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Group A Poison Sales

The sale of this category of poison is strictly controlled, with limited availability.

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Medical Practitioner Poison Dispensing

Licensed medical professionals can dispense poisons for treatment purposes, under strict supervision.

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National Pharmaceutical Regulatory Agency (NPRA)

The regulatory agency responsible for pharmaceutical companies in Malaysia, ensuring the quality and safety of drugs.

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Pharmaceutical Company Licensing

Pharmaceutical companies require authorization and permits from the government to operate.

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Companies Commission of Malaysia (SSM)

This organization is responsible for registering and approving the establishment of pharmaceutical companies.

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Public Listed Company Shares

Companies that have shares available for the public to purchase must offer the public a period of time to buy them.

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Tax Incentives for Pharmaceutical Companies

These incentives can help pharmaceutical companies reduce their tax burden and encourage investment.

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Government Approval for Pharmaceutical Companies

The state government plays a role in authorizing the establishment of pharmaceutical companies within their jurisdiction.

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Study Notes

Pharmacy Regulation in Malaysia

  • The Pharmacy Board Malaysia is responsible for regulating the pharmacy sector in Malaysia.

Pharmacy Business Product Flow

  • The pharmacy business product flow in Malaysia involves pharmaceutical products, cosmetics, and poisons.

Pharmacy Profession and Practice

  • The Pharmacy Act 1952 (Act 371) governs the pharmacy profession and practice in Malaysia.

Setting Up a Community Pharmacy or Pharmaceutical Company

  • The main focus of setting up a community pharmacy or pharmaceutical company in Malaysia is to obtain necessary licenses and permits from the relevant authorities.

Advertising of Medicines

  • The Medicine Advertisement Board (MAB) is responsible for controlling the advertisement of medicines in Malaysia.
  • The primary role of the MAB is to ensure that advertisements for medicines comply with the regulations.

Regulation of Drugs

  • The Dangerous Drugs Act 1952 (Act 234) governs the regulation of dangerous drugs in Malaysia.
  • The Sale of Drug Act 1952 (Act 368) regulates the sale of drugs in Malaysia.
  • The primary purpose of the Sale of Drug Act 1952 is to ensure the safe and controlled sale of drugs.

Poisons Act

  • The Poisons Act 1952 regulates the sale and use of poisons in Malaysia.
  • The Poisons Act 1952 allows only licensed wholesalers to sell poisons by wholesale.
  • The sale of Group A poison is restricted in Malaysia.
  • Licensed medical practitioners are permitted to supply poison for the purpose of treatment.

Pharmaceutical Companies

  • The National Pharmaceutical Regulatory Agency (NPRA) is responsible for regulating pharmaceutical companies in Malaysia.
  • The primary role of the NPRA is to ensure the safety and quality of pharmaceutical products.
  • Pharmaceutical companies are required to obtain necessary licenses and permits from the relevant authorities.
  • The Companies Commission of Malaysia (SSM) is responsible for approving the setting up of pharmaceutical companies.
  • Public listed companies are required to have their shares offered to the public for fixed periods.

Tax Incentives

  • Pharmaceutical companies can apply for tax incentives in Malaysia.

Government Approval

  • The state government is responsible for approving the setting up of pharmaceutical companies in Malaysia.

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Description

Explore the laws and regulatory authorities governing the pharmacy profession in Malaysia, including the Registration of Pharmacist Act, Poisons Act, Dangerous Drugs Act, and Sale of Drugs Act. Learn about the roles and functions of regulatory bodies overseeing the pharmacy sector.

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