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Regulatory

Nutraceuticals and Dietary Supplements

Nutraceuticals and Dietary supplements, despite their dosed form, are are governed by food legislation, both specific to dietary supplements and general food laws. The primary objective of food legislation is to ensure a high level of protection for human health, and it applies to all stages of production, processing, packaging, storage, distribution, import, and commercialization of dietary supplements.

Nutraceuticals and Dietary Supplements Solutions

  • Advice on the regulatory strategy and preparation of the corresponding Roadmap.
  • Advice related to the composition of the product (Evaluation of the legal adequacy of the formula).
  • Registration in the General Health Register of Food Companies and Foodstuffs (RGSEAA).
  • Hazard Analysis and Critical Control Points (HACCP), HACCP plan, prerequisite plans, validation of Critical Control Points, allergen management…
  • Notification or registration in other Member States for mutual recognition.
  • Novel food
  • Health Claims
  • Review of labeling and promotional material
  • Product marketing communication
  • Web audits
  • Application for Certificate of Free Sale (CLV)
  • Application for National Parapharmacy Code
  • Advice on market surveillance

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