Registration of Medicines
Before starting to market a medicine in Israel, there is a need to undergo a registration process to check its safety, efficacy and/or quality. At the end of this evaluation process, a marketing authorization from the Ministry of Health is obtained. The registration activities continue to accompany the medicine even after the Ministry of Health approves its marketing and during its entire marketing period in Israel
Our main goal is to ensure that your medicines comply with the Ministry of Health standards to guarantee quick registration at the national medicines registry of Israel as well as successful marketing by giving a comprehensive response to a variety of regulatory challenges during the lifecycle of your medicines.
Registration requirements of pharma companies
The Registration Department and the Institute for Standardization and Control of Pharmaceuticals in the Ministry of Health are central bodies of the Ministry of Health that deal with registration of medicines in Israel. Their activities are regulated according to the Pharmacists’ Regulations (Preparations), 1986 and according to procedures that are updated from time to time. In order to ensure the efficacy, safety and quality of the medicines marketed, stringent requirements were determined to which the registration holders need to comply with. They amongst others, include:
- Appointing an appointed pharmacist who will be responsible for all the medicine registration activities with the Ministry of Health.
- Submitting a detailed registration file and samples in order to obtain a license for marketing a new medicine (ethical, generic, bio-similar).
- On-going Monitoring and reporting of variations in the registration conditions and the registration file during the life cycle of the medicine.
- Coordinating the leaflets and artworks to the registrations conditions and updating them when required
- Deep familiarity with regulations and registration procedures (in Israel and the world) and keeping up to date with on-going changes.
- Reporting to the authorities, medical staff and the public as well as taking immediate measures if suspicious that the quality, safety or efficacy of the medicine may have been harmed.
- Receiving approval from the Ministry of Health for any promotional material intended for the public.
- Performing marketing activities for the target audience of the medical staff according to the registration conditions that were set by the regulator.
- Receiving an annual import approval for the marketing of registered medicines manufactured outside of Israel.
- Ensuring regular supply and taking necessary measures in cases where the availability of the medicine is doubt.
Our services for registration of medicines
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 stringent requirements of the Ministry of Health. BLAU Pharmaceutical Services obtain approvals that will enable you to quickly market your medicines and to handle the maintenance of marketing approvals (licenses) in the best manner:
- Regularly or temporarily filling the role of Appointed Pharmacists
- Submitting requests for registration of a new ethical medicine for use in humans (of chemical or biological origin)
- Submitting requests for registration of a new generic medicine, including bio-similars
- Submitting requests for registration of a new veterinary medicine
- Submitting requests for addition/update of the indication, variation of dosage regimen, addition of dosage form and administration
- Submitting requests for registration renewal (extension of license validity) for medicines of chemical or biological origin, and veterinary medicines
- Submitting requests for registration variations for medicines of chemical or biological origin, and veterinary medicines
- Efficient and professional support after the above mentioned activities up to obtaining the approval from the Ministry of Health
- Ongoing handling of leaflet updates and other artwork updates
- Consultation regarding classification of products for registration purposes
- Handling import permits for marketed medicines, samples for registration and raw materials
- Review and submission of promotional materials to the Ministry of Health for approval
- Ongoing updates regarding regulatory changes in Israel and internationally
In conclusion, due to the diligence, professionalism, creativity and the close working relationship with the authorities, the customers of our company have increased the amount of medicines registered which has led to a growth in their business activities.