The main obligation of Importers of natural health products to Canada is to comply with Natural Health Products GMP requirements. The purpose of these requirements is to ensure that imported products meet the same quality, safety and efficacy standards as locally manufactured products.

1.What Standards should imported products meet?

The regulations place an important the responsibility on the importer of natural health product. The importer is to ensure that any product they brought to Canada meets certain quality standards. These standards d include manufacturing, labeling and packaging from sites that meet the Canadian regulations.

2. How imported natural Health Products should be stored

When natural health products are imported to Canada, they should be stored in premises that comply with natural health products GMP requirements. Such premises should have a site license. The conditions of storage must maintain the quality of the natural health product and subsequently its safety.

3. Appropriate Equipment required

The importer should ensure that the manufacturing, packaging, labeling and storage of any products they import meets natural health products GMP requirements. In addition the equipment used should be designed and constructed to meet and fulfill the required objectives. It should undergo regular maintenance. This equipment should be operated and organized in a manner that, allows effective cleaning of relevant parts, so that it functions in accordance with its intended purpose. The equipment should be constructed to prevent contamination of the natural health product. It should not add any extraneous substance to the natural health product

4. Qualified personnel are needed

It is required that all personnel handling natural health products have appropriate education. The required education may include on-going GMP training or other relevant training. Personnel must have the practical experience which is necessary to carry out their assigned duties. The evidence of education and training must be demonstrated as records in personnel file and updated regularly.
It is the responsibility of the importer to ensure that they import natural health products from companies with evidence that personnel in-charge of manufacturing and quality assurance have the appropriate education, training or relevant practical experience to exercise control and supervise the activities.

Natural Health Products GMP requirements

5. Practices and procedures that must be in place

Importing from sites that have consistent practices and procedures is easier than sites that don’t have them in place. Importers should import from sites that have practices and procedures in place for material control to ensure quality of material used and quality of the product. They should also ensure the sites have, process control and product recall procedures that are consistent with Natural Health Products GMP requirements

6. Importers to review a supplier’s certificate of analysis

To ensure that imported products meet the required specifications, importers are required to review a supplier’s certificate of analysis. This certificate must be submitted with each lot shipped to Canada. During the review, the importer should verify that all the required testing has been carried out and that specifications are met.

7. Why Stability of NHP is required

I you are an importer stability studies should be performed so that you can determine the period of time that, after packaging for sale, the natural health product will continue to comply with its approved specifications when stored as recommended. If there are no recommended storage conditions the natural health product should be stored at room temperature but this must be supported by stability studies.

8. Samples must be maintained

To meet natural health products GMP requirements, the importer should maintain samples in their final packaging as evidence of product quality. They are important in case an investigation is required due to customer complaint or product recall. These samples should be maintained in an environment that is similar to regular storage conditions in the store to ensure the sample is equivalent to products available for sale.

9. Importers must keep records to comply with Natural Health Products GMP requirements

If you are an importer and of natural health products in Canada you should maintain the following records for natural health products:
• the master production document;
• a list of all medicinal and non-medicinal ingredients contained in each lot or batch;
• records of any testing carried out with respect to a lot or batch;
• a copy of the approved specifications;
• records containing adequate information to permit the recall of every lot or batch made available for sale and a
• copy of the sanitation plan in use by the importer.

10. Importers must maintain recall procedures

The importer must maintain a recall system and recall reporting to implement a product recall successfully. This ensures that all the relevant information is accessible and all the natural health products presented for sale are correctly presented to the public.