Cosmetic Products Registration in Israel in order to Obtain Ministry of Health Licenses and Preparation of Product Information Files for the European Market
Dr. Sara Tal
Dr. Sara Tal has been engaged in the regulation and registration of cosmetic products in Israel since the year 2000. She has founded and managed the Cosmetics Registration Department at Aminolab for over ten years.Several years ago, she started an independent business in the same field.
The New Regulation
The Ministry of Health in Israel has been working on implementing a new regulation for cosmetic products; mainly switching from pre-market registration to in-market control, similar to the regulation in Europe since July 2013.
I have heard about the new cosmetic regulation in Israel, according to which we will not have to submit applications to the Ministry of Health for licenses and we will not have to wait in the queue for long periods before we put products on the market. Is it true? When the new law will come into force?
Cosmetic Registration in Israel
- Consulting for new clients and explaining the process of product licensing from beginning to end, including assistance in obtaining a business license and a general cosmetics license.
- Registration of new products, renewal of licenses, reformulations, addition of shades, names and sizes and ownership transfer.
- Sending the products to approved laboratories for microbiological and chemical analyses, as required by the Israeli Ministry of Health.
- Compiling the necessary data from the importer and producer, providing them with explanations and examples of the required documents.
- Preparation the submission files for licenses using the software of the Israeli Ministry of Health (Magic), while ensuring their compliance with the regulatory requirements.
- Submitting the files to the Israeli MoH, both electronically and hard copies.
- Receiving of licenses from the Ministry of Health and sending them to the client
- Supporting the client in preparing the label for marketing in Israel.
- Preparing each client’s existing licenses status and reminding them to renew their licenses prior to their expiry.
Cosmetic Registration in Europe
- Guidance and counseling for new clients regarding the European Regulation EC 1223/2009.
- Preparation of PIF (Product Information Files) for products to be marketed in Europe – including compiling of all relevant documents for the product and its raw materials, laboratory testing by an approved laboratory, preparation of documents for Safety Assessment Report, preparing labels and product images, etc.
- Connecting to a Responsible Person in Europe, who, after reviewing and approving the PIF, will notify the product in Europe and will represent the Israeli client in Europe during the period that the product is in the market.