Pharmacovigilance Glossary

MAH (Marketing Authorisation Holder)

Every approved medicine needs one company willing to put its name on the license and answer for it for as long as it stays on the market. The Marketing Authorisation Holder is that company.

What is it?

The MAH is the legal entity that holds the license to market a medicine in a given country or region, and carries the ongoing regulatory responsibility that comes with it. It isn't necessarily the company that manufactures the product; licensing and distribution arrangements can put the authorization in one company's name while another does the manufacturing.

Holding a marketing authorization isn't a one-time approval event. It comes bundled with a standing set of obligations that run for as long as the product stays on the market.

What the MAH is actually on the hook for

Hover each duty to see what it involves.

Hover a duty to see what it covers

MAH

Safety Database

Runs the system that collects, processes, and stores every case reported for its products.

RMP Upkeep

Keeps the Risk Management Plan current as new safety data comes in from any source.

QPPV Appointment

Must name and properly support a Qualified Person for Pharmacovigilance at all times.

Regulatory Reporting

Submits ICSRs, PSURs, and label variations on every deadline that applies.

Common Misconceptions

Myth

"MAH just means whichever company manufactures the medicine, right?"

Truth

Not necessarily. The MAH is a specific legal role tied to holding the authorization itself, and it can be a different company from the one actually manufacturing the product. Whoever holds the authorization carries the pharmacovigilance responsibility, regardless of who makes it.

MAH (Marketing Authorisation Holder)

What is it?

What the MAH is actually on the hook for

Common Misconceptions

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