What is product monograph?

A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.

Who is responsible for quality control in natural health products?

Product licence holders are ultimately responsible for ensuring the quality of their licensed NHPs, and for the establishment of the product specifications, as per section 44 of the NHPR.

What is the main role of the natural and non prescription health products directorate?

developing and updating policies and guidance on natural health products and non-prescription drugs. supporting actions in response to identified product risks. establishing and maintaining relationships with stakeholders.

What do natural health products include?

Natural health products, often called “complementary” or “alternative” medicines, include:

• vitamins and minerals.
• herbal remedies.
• homeopathic medicines.
• traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines.
• probiotics.
• other products like amino acids and essential fatty acids.

What is monograph used for?

Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria.

What is ingredient monograph?

Single Ingredient Monographs A monograph is a written description of particular elements on an identified topic. Single ingredient monographs apply to formulations containing only one medicinal ingredient.

Who regulate GMP in Canada?

Health Canada
1. Purpose. Health Canada inspects buildings where drugs are fabricated, packaged/labelled, tested, imported, distributed, or wholesaled against requirements for good manufacturing practices (GMP). This helps verify that safety and quality standards are met by those selling drugs to Canadians.

Are natural health products drugs?

Natural health products are regulated as a subset of drugs under the Food and Drugs Act. Finally, foods are generally not subject to pre-market review and assessment by Health Canada before they can be sold.

Who regulates natural health products in Canada?

Health Canada regulates natural health products (NHPs) so that Canadians can have confidence that the products they use are safe, effective and of high quality.

How are natural health products approved in Canada?

Product licensing All natural health products must have a product licence before they can be sold in Canada. To get a licence, applicants must give detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s).

What are the five examples of health products?

These are five of the most common health products in 2019.

• Herbal Supplements. Herbal supplements are a multi-billion dollar global industry that is expected to hit $8.5 billion by 2025.
• Coconut Water & Coconut Oil.
• Cannabidiol (CBD)
• Activated Charcoal.
• Probiotics.

What are examples of health products?

Examples of products that are captured under the Consumer Health Products Framework include toothpastes, sunscreens, vitamins and minerals, contact lens solution, pain relievers, cold remedies, antiperspirants and disinfectants.