28 April 2010, 10:03 PM - Khaleej Times

All pharmaceutical and medicine companies in the country are now required to appoint at least one pharmaco-vigilance officer within six months.

The decision was issued recently by the Medical Practices and Licences Section at the Ministry of Health, demanding all pharmaceutical and medicine companies registered at the Registration and Pharmaceutical Drugs Department to appoint a pharmaceutical vigilance officer in their organisations, said Dr Amin Al Amiri, Executive Director for Medical Practices and Licences at the ministry.

The pharmaco-vigilance officer must be a doctor, pharmacist, drugs specialist or toxicologist and must have practical experience in monitoring and following up the reports of the side effects of drugs, clinical studies and clinical pharmacology, he said.

“All pharmaceutical manufacturers and medical companies have been asked to provide their pharmaceutical vigilance and risk management plans at the time of registration or renewal,” said Dr Al Amiri.

The risk plan must cover 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 or international drugs control association in terms of their safety and side effects.

All companies have also been asked 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 six months and one year, an annual record of the products that have been registered between one and three years and a progress report every three years for the products that have been registered for more than three years,” he said.

“The companies are requested to send their regular reports of the products’ safety and side effects to the Registration and Drugs Control Department at the Ministry of Health. In addition, the companies are given a six-month grace period to begin implementing the new decision.”