When EMVO uses the abbreviation MAH, it only refers to Marketing Authorisation Holders.
Marketing Authorisation Holder (MAH)
A Marketing Authorisation Holder is the organisation that owns the serialisation data and is responsible for uploading this data to the EU Hub (for example, XYZ Sales Company in an EU Member country). Possibly an affiliate of the OBP; in smaller companies, the MAH and the OBP can be the same entity.
Manufacturing Authorisation Holder
Both the manufacturing of pharmaceuticals in line with the requirements of their marketing authorisation and the repackaging of finished goods (which is part of parallel distribution) fall under GMP requirements and therefore require a manufacturing authorisation. As a result, both types of companies are connected to the EU Hub, but using different interfaces.
Accordingly, the FMD uses the term “manufacturing authorisation holders” to refer, on the one hand, to marketing authorisation holders and, on the other hand, to 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.