Monday, May 10, 2010

Pharmaco-vigilance officers mandatory in UAE pharmacies

The Gulf Today, 29 April 2010

The UAE Ministry of Health (MoH) requires all pharmaceutical establishments operating in the country to employ well-qualified vigilance officers within a period of six months.
The medical practices and licensing department of the MoH has issued a circular on Wednesday in this regard. The circular specifies that all pharmaceutical or medicine production companies which are registered with the ministry's registration and pharmaceutical drugs department should recruit a pharmaceutical vigilance officer, said a senior MoH official.
Dr Amin Al Amiri, Executive Director for Medical Practices and Licensing at the MoH, said that the pharmaceutical vigilance officer could be a doctor, pharmacist, drugs specialist or toxicologist.
According to him, the MoH has addressed all pharmaceutical manufacturers and medical companies to provide their pharmaceutical vigilance and risk management plans at the time of registration or renewal.
Dr Amiri explained, "The plans include medical products, pharmaceuticals, innovative pharmaceutical products containing active substances registered for the first time, medium or high risk products, This is in addition to other products that have been included in the MoH's previous circulars." "The MoH also has demanded all pharmaceutical or drug manufacturing firms to provide the ministry with an updated safety list of their pharmaceutical and medical products," he noted.
"The reports must include an year's details on the medical products that have been registered between six months to one year, an annual record of the products that have been registered between one 1 to three years and a progress report every three years for the products that have been registered for over three years," he pointed out.
"The reports should be submitted at the MoH's Registration and Drugs Control Department, he added.

No comments:

Post a Comment