UAE Ministry of Health stated that all pharmaceuticals and medicine companies registered at the Registration and Pharmaceutical Drugs Department will be required to appoint a pharmaceutical vigilance officer in their organizations.
Dr. Amin Al Amiri, Executive Director for Medical Practices and Licenses at the UAE Ministry of Health the decision, explained that all the above mentioned companies are requested to appoint a pharmaceutical vigilance officer who must be a doctor, pharmacist, drugs specialist or toxicologist. This officer must have a practical experience in monitoring and following up the reports of drugs side effects, clinical studies and clinical pharmacology.
Dr. Al Amiri said: “All candidates must provide their approved documents including qualifications, experiences, contact information, fax, mobile, phone and email addresses. We addressed all pharmaceutical manufacturers and medical companies to provide their pharmaceutical vigilance and risk management plans at the time of registration or renewal.
The plans include medical products, pharmaceuticals, innovative pharmaceutical products containing active substances registered for the first time, medium or high risk products in addition to other products that have been included in previous circulars by the Ministry of Health or international drugs control association in terms of their safety and side effects”. Dr. Al Amiri explained that the decision demanded all the companies to provide the ministry with an updated safety list of their pharmaceutical and medical products. Such reports must include a yearly detailed report of the medical products that have been registered between 6 months-1 year, an annual record of the products that have been registered between 1-3 years and a progress report every 3 years for the products that have been registered for more than 3 years.