Health Products Act (HPA) Overview

This set of flashcards covers key concepts from the Health Products Act (HPA) lecture, focused on product registration, licensing, Good Distribution Practice, and the responsibilities of product registrants and license holders.

What is the primary legislation related to health products in Singapore?

Health Products Act (HPA)

What is one key outcome of product registration under HPA? What is the criteria for product registration.

Ensure products meet safety, efficacy, and quality standards to obtain safe and effect therapeutic product.

Define Good Distribution Practice (GDP).

Good Distribution Practice is the process where the quality and the integrity of the therapeutic product is maintained consistently through transportation, manufacturing and importing.

What does the term 'Unique SIN number' refer to in product registration?

A specific identifier assigned to a registered therapeutic product.

What are the criteria for product registration?

Safety, efficacy, and quality of the product.

What is the purpose of the Activity-based licensing framework?

The purpose of activity-based licensing is to give licenses to for specific activities carried out with the therapeutic product. This framework ensures that HSA is able to oversee production in specific activities and maintain safety standards.

What distinguishes Prescription-Only Medicines (POM) from other classifications?

For POM, only doctors can prescribe the medicine to patients after diagnosis and assessment of their health needs. They must be closely monitored.

Name one type of therapeutic product that can be sold pharmacy-only.

Pharmacy-Only Medicines (P) which need pharmacist supervision such as proton pump inhibitors for heartburn, medications for a cold and nicotine replacement therapy.

What kind of medicines are classified as General Sale List (GSL)?

Medicines that can be sold without medical supervision for minor ailments that is self-limiting and has a short duration. The packaging and labelling of the product must include clear instructions for safe usage and also any contraindications, drug interactions, and potential side effects. Quantity given should only be enough for short-term to reduce risk of excessive consumption 

What does a Therapeutic Product Importer's Licence (TPIL) authorize?

It authorizes the holder to import health products.

In what scenario is a TPWL required?

When supplying any health product by wholesale.

What must companies do if they deal with unregistered therapeutic products?

They must obtain prior approval from HSA before importing such products.

What must a company ensure when handling therapeutic products?

Compliance with standards set by the authority regarding storage and handling.

What is required from the Responsible Person (RP) in a company?

Must implement Good Distribution Practice and maintain quality standards.

What can lead to the cancellation of a therapeutic product registration?

Failure to pay the annual retention fee or decision by the HSA.

What is the role of the product registrant?

Ensure accurate application information and report new health information impacting product use.

What is the significance of the 'Named-patient exemption route'?

It allows import of unregistered therapeutic products when no registered alternatives are available.

What obligations does a TPWL holder have regarding product supply?

Must ensure compliance with quality and regulatory standards.

What happens to therapeutic products if the registration is suspended?

They will be removed from the Register.

Define the responsibilities of a Responsible Person (RP).

To ensure compliance with GDP and maintain the quality of therapeutic products.

How often must licenses under HPA be renewed?

Annually.

Describe the criteria for safety in product registration.

Products must be free from harmful effects.

What are the potential consequences of not maintaining product quality?

Health risks to patients and loss of company reputation.

What does the acronym HSA stand for?

Health Sciences Authority.

What must be done with records of defects and adverse effects?

They must be maintained and reported to relevant authorities.

When can a company apply for a 'term' or 'consignment' TPIL?

Based on operational needs for importing health products.

What is meant by 'activity-based licensing'?

Licensing based on the specific activities related to the therapeutic products.

What types of information must an application for product registration include?

All truthful and non-misleading information related to the product.

What is the role of Good Distribution Practice in healthcare?

To maintain the quality and integrity of products throughout the supply chain.

What does a therapeutic product must demonstrate to obtain registration?

Compliance with quality, safety, and efficacy criteria.

What must companies do to bundle TPIL and TPWL applications?

They need to apply for both licenses at the same time to receive a lower fee.

How is quality ensured during the distribution of therapeutic products?

Through adherence to Good Distribution Practice.

What factors are considered for the evaluation of a registered product?

Quality, safety, and efficacy.

What must a company doing wholesale ensure regarding therapeutic products?

Only sell to legally permitted individuals or entities.

What does 'efficacy' mean in the context of therapeutic product registration?

The product must demonstrate that it produces the intended therapeutic effects and benefits.

What does 'quality' refer to in the criteria for therapeutic product registration?

The product must consistently meet defined standards, specifications, and attributes throughout its lifecycle.

What is the overarching role of the Health Sciences Authority (HSA) concerning health products?

To ensure the safety, quality, and efficacy of health products in Singapore through regulation and enforcement.