Gali Amir

New Cosmetics Regulation 2023

Preparing companies for the new Israeli Cosmetics Regulation 2023

GALI AMIR Regulatory Services LTD is well prepared to support the transition to the new cosmetics reform 2023 which includes a general adoption of European Regulation (EC) No. 1223/2009.

The reform in the field of cosmetics, which implemented on April 1st 2023, aims at adopting the principals of the European regulation, by updating the Israeli regulation.

The main changes established by the reform in cosmetics are:

  1. The reform includes a general adoption of European Regulation subject to the regulator’s discretion to adopt national deviations. Goods that will be eligible to be included in the reform, will be imported to Israel subject to compliance of the importer in the domestic laws’ requirements such the appointment of a person or an organization that will be registered as RP “Responsible Person“.
  2. The reform reduces bureaucracy in applications for an import license in parallel import of goods, such as an omission the requirement of documents originating from a manufacturer.

All import regulatory tracks that were exist before the reform will be available for at least the next four years after January 1st, 2023.

GALI AMIR – Regulatory Services LTD is approved by the Ministry of Health (according to the new standardization) and assigned a certified RP for this purpose.

There are several pathways to be compliant with the new cosmetics regulations (reform 2023) of the Ministry of Health:

  • Outsourcing of the regulatory department, RP service for the company.
  • Preparation and process of cosmetics dossiers by product.
  • Preparation of the company and establishing a regulatory department according to the new regulations.

Safety Assessment – Safety Assessment for Cosmetics

GALI AMIR Regulatory Services LTD prepares and conducts safety assessments with the assistance of its expert employees who are certified as Safety Assessors.

Cosmetovigilance – Monitoring Side Effects in Cosmetics.

GALI AMIR – Regulatory Services LTD provides product adverse effects reporting services for cosmetics which offer solutions in accordance with the requirements of the new Cosmetics reform 2023.

Consulting services

OUR SERVICES

We at Gali Amir Registration and Regulation of cosmetics, medical accessories, and consumer products, including new registration, renewal, parallel importation, preparation, and more.

Consulting, Registration and Regulations.

Our values

WHY US?

YEARS OF EXPERIENCE AND PROVEN TRACK RECORD

Over 20 years of expertise in regulations

A TEAM OF EXPERTS

A team of experts for regulation, pharmaceuticals, medical accessories and consumer products

MULTILINGUAL STAFF

Multilingual staff:
Hebrew, English, Arabic and Russian.

PROFESSIONAL STANDARDS

Efficiency, professionalism and reliability

Industries we serve

Who we serve

Importers

Parallel import process subject to a free import order

Exporters

Permits and licenses for the export of goods from Israel to any country in the world

Manufacturers

Registration of medical preparations and accessories

Suppliers

Supply of licenses and approvals for the various products

CONTACT OUR TEAM

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