UNDANG -UNDANG KEFARMASIAN

Summary

This video covers Indonesian Law No. 17 of 2023, which regulates pharmaceutical practices. It highlights key aspects such as the definition of pharmaceutical products, including medicines, natural drugs, cosmetics, and health supplements. The law mandates compliance with Indonesian Pharmacopoeia standards and outlines the roles of pharmacy professionals in production, quality control, and distribution. Additionally, it emphasizes the use of domestic raw materials in pharmaceutical production, aiming to enhance local industry and ensure public health safety.

Takeaways

• 😀 The law discussed is Indonesian Pharmaceutical Law No. 17 of 2023, which regulates health and pharmaceutical practices.
• 😀 The law defines pharmaceutical preparations as including drugs, herbal substances, health supplements, cosmetics, and quasi-drugs.
• 😀 All pharmaceutical preparations must meet Indonesian Pharmacopoeia standards or other recognized standards.
• 😀 Herbal products must adhere to the Indonesian Herbal Pharmacopoeia or recognized standards.
• 😀 Health supplements and quasi-drugs must comply with the Indonesian Pharmacopoeia or other acknowledged standards.
• 😀 Cosmetic products must meet the Indonesian Cosmetic Code or other recognized standards.
• 😀 Raw materials used in pharmaceutical preparations must meet quality standards, especially for local production of raw materials.
• 😀 Pharmaceutical practices should be carried out by qualified pharmaceutical personnel, including pharmacists and pharmacy specialists.
• 😀 Certain limited pharmaceutical tasks may be performed by other healthcare professionals, as allowed by law.
• 😀 The law outlines that pharmaceutical practices cover production, quality control, procurement, storage, distribution, research, and development.
• 😀 The law encourages the use of local raw materials in the production of pharmaceutical products and medical devices within Indonesia.

Q & A

What is the main focus of the Undang-Undang No. 17 Tahun 2023?

The main focus of the law is to regulate pharmaceuticals in Indonesia, including the definition of various pharmaceutical products and their required standards, as well as the practices and personnel involved in pharmaceutical services.

What are the key pharmaceutical preparations defined in the law?

The law defines several pharmaceutical preparations, including medicines, medicinal substances, herbal medicines, health supplements, cosmetics, and quasi-medicines.

What standards must pharmaceutical preparations meet according to the law?

Pharmaceutical preparations must meet the standards set by the Indonesian Pharmacopoeia or other recognized standards, including the Indonesian Herbal Pharmacopoeia for herbal medicines.

How are the practices of pharmacy regulated in the law?

Pharmacy practices, such as production, quality control, procurement, storage, distribution, and research, must be conducted in accordance with the law and the standards set by the relevant authorities.

Can healthcare workers other than pharmacists engage in pharmaceutical practices?

Yes, the law allows healthcare workers other than pharmacists to be involved in limited pharmaceutical practices under specific conditions, as determined by regulations.

What does the law say about the personnel involved in pharmacy practices?

The law specifies that pharmacy practices should be carried out by qualified personnel, including pharmacists, pharmacy specialists, and vocational pharmacy workers.

What is the requirement for the raw materials used in pharmaceutical products?

The law requires that pharmaceutical products and medical devices produced in Indonesia prioritize the use of locally sourced raw materials whenever possible.

What does the law state about the quality control of pharmaceutical products?

The law mandates that pharmaceutical products must undergo quality control to ensure they meet the required standards, such as those defined by the Indonesian Pharmacopoeia and other recognized authorities.

How does the law impact the research and development of pharmaceutical products?

The law encourages research and development within the pharmaceutical sector, ensuring that new products and practices comply with the established standards and regulations.

What does the law outline regarding the distribution of pharmaceutical products?

The law outlines that the distribution of pharmaceutical products must follow strict guidelines to ensure the products reach consumers safely and are in compliance with regulatory standards.