The Registration Department is a central department in the Pharmaceutical Administration. This is the body that deals with the registration of medicines in Israel. The Department’s activity is regulated under the provisions of the Pharmacists’ Regulations (Preparations) 1986 and under the provisions of Procedures that are updated from time to time.
According to the Pharmacists’ Regulations (Preparations) 1986, a medicine shall be registered in the National Drugs Registry only after its safety, efficacy and quality have been proved. The decision regarding the registration of a medicine is made only after proper thorough and critical assessment of the information submitted about the medicine. Registration is intended to protect public health and constitutes a barrier to the marketing of poor quality and dangerous medicines on the one hand, while enabling the marketing of effective and safe medicines on the other hand. Registration by a government body enables physicians to prescribe medicines to their patients with confidence. In the Registration Department, policies are set regarding the registration of preparations containing new substances, approval of generic preparations, rules regarding limitations to the marketing of a medicine, information to the public by means of patient information leaflets, information to physicians and pharmacists by means of physician leaflets, policy regarding approval of advertising of medicines, and more.
The Registration Department is responsible for the content of the Drug Registry, for updating it and for improving it.
Services provided by the Unit
- Registration of a new medicine
- Renewal of registration of a medicine
- Change to the registration of a medicine
- Approval for advertising a medical preparation
