All Collections
Getting started with EMVO
Marketing vs. Manufacturing Authorisation Holder
Marketing vs. Manufacturing Authorisation Holder
Written by Tracy Slosse
Updated over a week ago

When EMVO uses the abbreviation MAH, we ONLY use it in relation to Marketing Authorisation Holders.

Marketing Authorisation Holder (MAH) A Marketing Authorisation Holder is the organisation which owns the serialisation data and which is accountable for uploading the data to the EU Hub (e.g. XYZ Sales Company in EU member country). Possibly an affiliate of the OBP; for smaller companies the MAH and OBP could be the same.

Manufacturing Authorisation Holder Both the manufacturing of pharmaceuticals according to the requirements of its marketing authorization and the repackaging of finished goods (which is the activity of parallel distribution) are subject to GMP rules and require a manufacturing authorisation. Both types of company are thus connected to the EU Hub but using different interfaces.

The FMD correspondingly speaks of "manufacturing authorisation holders" when it means on the one hand marketing authorisation holders and on the other parallel distributors. Parallel distributors connect to the EU Hub, comparable to the other original pack manufacturers as they place “new” repackaged medicinal products on the market.

Did this answer your question?