In the Philippines, a Local Authorized Representative (LAR) is a legal entity registered with the Food and Drug Administration (FDA) that represents a foreign manufacturer or supplier in regulatory matters. This representative ensures that products meet the regulatory requirements of the Philippines and serves as the point of contact for the FDA Philippines.
Local Authorized Representative
Key responsibilities:
- Product Registration: Submitting necessary documentation and ensuring that products comply with local regulations for registration.
- Communication: Acting as the liaison between the foreign manufacturer and the FDA Philippines.
- Compliance: Ensuring ongoing compliance with local laws and regulations, including post-market surveillance.
- Product Recalls: Managing product recalls and adverse event reporting.
To become an LAR, the entity must meet specific requirements and go through the registration process with the FDA Philippines. This process includes providing necessary documents, such as a letter of authorization from the foreign manufacturer, business permits, and other relevant certifications.
