Registration of Nutritional Supplements

Before starting to market a nutritional supplement or medical food in Israel, there is a need to undergo a registration process at the Ministry of Health to check its safety and quality. At the end of the evaluation process of the nutritional supplement or medical food at the Ministry of Health, a marketing approval may be obtained. The registration activities accompany the nutritional supplement also after the Ministry of Health approval (License) for its marketing has been obtained and during its entire marketing period (life cycle) in Israel.
Our main goal is to verify that your nutritional supplements comply with the Ministry of Health standards to ensure that a license is received quickly to commence marketing.
Blau Pharmaceutical Services will contribute to successful marketing of your nutritional supplements by giving a comprehensive response to a variety of regulatory challengesduring the life cycle of your nutritional supplements.

Registration requirements of importers and manufacturers of nutritional supplements and medical food

Importers and local manufacturers of nutritional supplements are required to act according to the public health regulations (food) (nutritional supplements) 1996, and according to the guideline document of the Ministry of Health for submitting a request for registration and import of nutritional supplements.
The national food service is the central body in the Ministry of Health that deals with registration of nutritional supplements and medical food in Israel.
It is important to know what the regulatory challenges you will be required to comply with are in order to market a nutritional supplement in Israel
  • Determining the order of the activities required for submitting a request for a license for a nutritional supplement or medical food
  • Registration as an importer or manufacturer in the food and nutritional services
  • Obtaining a license for marketing a new nutritional supplement
  • Renewal (extension of validity of approval) of license of nutritional supplements and medical food
  • Ongoing release of nutritional food supplements from the quarantine of the Ministry of Health
  • Preparation of text for the label / package of the nutritional supplement, graphic preparation and printing of the label / package Read more…
  • Types of nutritional supplements that require microbial tests
  • Proving the shelf life of a nutritional supplement
  • Manner of handling rejection from the Ministry of Health of a request for a license to market a nutritional supplement or medical food
  • Organized maintenance of nutritional supplement licenses including regular contact with the manufacturer and updating the Ministry of Health of any change in the license

Our services for registration of nutritional supplements and medical food

Peter Blau, a graduate of the department of drug registration at the Ministry of Health and his devoted staff of BLAU Pharmaceutical Services offer you the following solutions in order to comply with the requirements of the Ministry of Health. Blau Pharmaceutical Services obtain licenses that will enable you to quickly market your nutritional supplements and medical food, and to handle the maintenance of marketing approvals (licenses) in the best manner:

  • Regularly or temporarily handling of the registration of nutritional supplements and medical food
  • Handling the registration of the license requester as an importer or manufacturer at the national food service of the Ministry of Health
  • Obtaining the official documents from the manufacturer (such as certificate of analysis and composition) and from the authorities of the country of origin (such as certificate of free sale, GMP certificate)
  • Submitting requests for registration of a new nutritional supplement / medical food
  • Submitting requests for the release of a batch from quarantine
  • Submitting requests for renewal of a nutritional supplement / medical food
  • Submitting requests for variations in the terms of license of a nutritional supplement
  • Conducting microbial tests (when required)
  • Keeping track in an efficient and professional manner after the progress of the above mentioned activities up to obtaining the approval from the Ministry of Health
  • Preparation of labels, packages and leaflets, including ongoing handling of updates
  • Consultation regarding classification of products for registration purposes such as nutritional supplement verus medicine
  • Translation and graphic design of promotional and marketing artworks including printing
  • Ongoing updates regarding regulatory changes in Israel

In conclusion, due to the professionalism, the devoted regulatory staff and the profound familiarity of Blau Pharmaceutical Services with the requirements of the Ministry of Health, you can also increase the amount of nutritional supplements and medical foods that you wish to market