What is a Letter of Authorisation?

What is a Letter of Authorisation?

A Letter of authorisation (LoA) is a formal document that gives permission or authority to a third party to act on behalf of another party. It provides formal permission or consent granted by one party to another and the authorization is typically granted within the context of regulatory submissions and interactions with regulatory authorities. The main purpose of an LoA is to essentially “empower” either an individual or organization within regulatory affairs to act on behalf of the “submitting entity”. This is done with the aim to streamline communication and ensure compliance with regulatory requirements.

In situations where a third party, i.e., a regulatory affairs service provider, is involved in preparing or submitting regulatory documents on behalf of a pharmaceutical company, a LoA becomes a critical document as it outlines the scope of authority that has been granted to the entity and specifies the tasks that they are “authorized” to conduct for the regulatory submissions they are handling.

The LoA provides regulatory agencies with a clear understanding on the entity or individual that has the legal standing to represent the pharmaceutical company for regulatory matters. This is integral for maintaining accountability and transparency throughout the regulatory process. In situations where pharmaceutical companies collaborate with external stakeholders, i.e., CROs or distributors, a LoA is essential in providing explicit authorization, through a formal letter, that the pharmaceutical company “authorizes” its external partner for carrying out regulatory activities on its behalf.