Philippines: New Guidelines for health products recall

 

Philippines have published Guidelines on the Recall of Health Products Regulated by the Food and Drug Administration.

The regulatory landscape of health products has changed significantly in Philippines, therefore the initially issued Guidelines on Product Recall needs to be revised. A Circular was promulgated to create an updated framework for the recall of products in pursuit of public health and safety.

It intends to establish a guideline on the recall of health products and effectively contribute in ensuring the safety and protection of the general public which present a substantial risk of injury, illness, and/or gross deception. Specifically, the Circular aims to:

1. Strengthen the recall system for health products under the jurisdiction of the FDA;
2. Specify the responsibilities and reporting obligations of the MAH in the conduct of product recall; and
3. Provide guidance to MAH in conducting effective recalls.

The circular can be found HERE.

To find out more compliance for health products worldwide, please contact the Product Compliance Institute directly.