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Probiotics/Prebiotics Registration and Notification Malaysia

Probiotics are live microorganisms which when administered in adequate amount can confer health benefits on the host. Probiotics promote a healthy balance of gut bacteria and have been linked to a wide range of health benefits. Another category of food additive which is beneficial to the human body is – Prebiotics. These are non-digestible ingredients which help in boosting the immune system of human body. Both prebiotics and probiotics help in boosting the immune system of human body and inhibit the growth of harmful gut bacteria, while promoting the production of natural antibodies in the body. In the current scenario of COVID-19, Probiotics/Prebiotics are considered critical to boost the immunity. But with the decline in the global supply chains of Probiotics/Prebiotics, meeting the demand right on time would be challenging.

To ensure the world sustain the international health crisis, as a prominent Probiotics/Prebiotics manufacturer you might be willing to market your products across the globe or to be specific in the Malaysia. In Malaysia, Probiotics/Prebiotics are regulated by the National Pharmaceutical Regulatory Agency (NPRA). According to the NPRA, prebiotics are not clearly classified and are termed as “Food-Drug Interphase (FDI) products”. There is another category of food supplement called Synbiotics, which is a combination of prebiotics and probiotics.

Probiotics/Prebiotics – Freyr’s Regional Focus

Freyr team has experience of working on Probiotic/Prebiotic applications and interacting with the NPRA. With a vast knowledge on the NPRA and probiotic Regulatory requirements, Freyr team of subject matter experts (SMEs) can assist you with compliance check of the product’s registration, label and claims. Freyr can assist you in preparing the product license application to be submitted to the NPRA and follow up with them until approval is received and also assist in claim consultation and claim review on a probiotic product label. Freyr is specialized in:

  • Probiotics/Prebiotics registration in Malaysia
  • Probiotics/Prebiotics market entry
  • Evaluation of your label or labeling information for compliance
  • Review of immunity boosting claims
  • Design or develop artwork for Immunity boosters
  • Review or assess the product formula to identify the product category and to check the acceptability of all the ingredients in the product in line with the NPRA
  • Suggesting mandatory, missing information and nutritional/supplemental facts or the corrections to be made on the label of the product as per the country specific regulations
  • Monitor compliance with the NPRA including advising on general labeling and advertising issues, nutrition labeling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
  • Prepare and submit dossier for Probiotics/Prebiotics registration
  • Assist with devising a robust Regulatory pathway for your product

As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track the registrations of Probiotics/Prebiotics in Malaysia. 

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