Guidelines for the process of cosmetics registration/submission in Israel
The Department that is responsible to assure the safety and quality of cosmetics products for the Israeli market is the Cosmetics and Toiletries department of the Israeli Ministry of Health. It is a sub-department in the pharmacy department and the Institute for Standardization (IFS). It is the department licensing cosmetics and certifying products in Israel.
The Israeli Ministry of Health is based on the European directive for registration of cosmetics and importer and manufacturers of cosmetics must follow the Israeli Ministry of Health’s current regulatory guidelines.
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Steps, challenges and requirements for cosmetics registration in Israel
Part of the regulatory requirements for cosmetics products submission in Israel is listed below:
- After the exact order of activity was determined as required by the Israeli Ministry of Health, a request must be submitted for a license of a new cosmetic product
- Obtain a general license for cosmetic products
- Obtain a license for marketing a new cosmetic product or renew the licenses of a pre-marketed cosmetics product in another country
- The text and graphics for the label and package of the cosmetics products should be arranged and submitted for printing. In the case the products are intended for domestic use, the labeling and instructions for use must be provided in English, Hebrew and Arabic. In the case the product is intended for professional use only within health facilities, the labeling and instructions for use may only be in English.
- Determine what kind of laboratory tests are required and complete the relevant tests by certified laboratories
- Obtain a certificate of free sale for exporting the cosmetic product
- Obtain a BSE certificate if required by the products
- Side effects must be continuously reported
- Maintain the cosmetics licenses and keep track of the process
- Update the Israeli Ministry of Health of any changes of the licenses or a licensed product
Dealing with the requirements and the different bodies of the Israeli Health ministry can be challenging, therefore we would be more than happy to assist you for any of these steps with a high degree of professionalism.
Bio-Chem has been advising biomedical companies for more than 13 years.
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