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Hand sanitizer spray wipes exported to Canada compliance small science

Release time:

2021-05-21 14:27

According to Health Canada (Health Canada) regulations, starting from September 1, 2014, all natural health products (Natural Health Products, NHPs) imported, produced and sold in Canada need to obtain Health Canada's Natural Product Batch Number (Natural Product Number, NPN) or Homeopathic Drug Batch Number (Homeopathic Medicine Number, DIN-HM). In addition to the NPN and DIN-HM lot numbers, Health Canada also requires that all natural health products be produced, imported, labeled, packaged, transported and stored in locations that meet the Canadian Good Manufacturing Standards Canadian Good Manufacturing Practices (GMPs) for NHPs.

Chinese enterprises export more epidemic prevention materials to Canada, such as alcohol disinfectant spray, alcohol wet wipes, hands-free disinfection gel, etc., all need to obtain the natural product batch number (Natural Product Number, NPN) of Health Canada in order to obtain the sales qualification in the Canadian market with the highest technical threshold, the most mature market and relatively many technical barriers. For products that have obtained NPN numbers, complete and detailed product information is provided to the Canadian Health Authority, including: ingredients, sources, doses and their strength, recommended intake methods and other relevant detailed information, giving consumers the protection of quality, purity and potency, and providing effective and high-quality natural health products.

The regulations impose license requirements on packaging, label manufacturers and health care product importers. These units can only operate, sell, store and transport health products after obtaining the corresponding site license. The regulator requires that the site with the site license must have the health care product wholesale records, product recall records and detailed records of handling, storage and transport products for reference at any time. The regulations stipulate that if a serious adverse reaction occurs in or outside Canada, the distributor must notify the Federal Ministry of Health within 15 days of being aware of the reaction. The Ministry of Health should make a safety assessment as soon as possible and decide on the countermeasures to be taken, including Stop sales, mandatory recall, and revoke licenses. The public can make online inquiries or direct telephone inquiries. Concealing and not reporting or adding illegal drugs without permission will directly face the danger of being out. Therefore, the NPN number is an extremely strict natural product number certification system, representing Canada's consistent high standards of quality and safety.

New Anrun Consulting provides a full set of services for Canadian NPN certification, DIN certification and GMP certification applications, including application evaluation, material preparation and follow-up, until certification is obtained.


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1. US FDA certification

2. US EPA certification

3. EU CPNP Notification

4. EU BPR Registration

5. Australian TGA Registration

6. Russian EAC Certification

7. Canadian DIN/NPN certification

8. Malaysia, Thailand, India and other countries compliance

 

For OTC products under the US FDA, the following services can be provided:

• apply for a Dun & Bradstreet number;

• Site registration;

• Apply for NDC;

• FDA product filings;

• Product label review;

 

For medical device products under the US FDA, the following services can be provided:

• The manufacturer is registered with FDA;

• FDA product registration;

Product listing registration (510 form registration);

• Product go-to-market review approval (PMA review)

New Anrun Chemical Regulations Advisory Services:
Declaration of new domestic chemical substances
Compliance services in countries where epidemic prevention materials are exported
Laboratory Testing Services
Registration of hazardous chemicals and business license for hazardous chemicals
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EU REACH, Taiwan REACH, South Korea K-REACH Registration
Food contact material declaration
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