Manufacturing and distribution authorisations and registrations of active pharmaceutical ingredients (API) distributed digitally

Source: FAMHP

April 2, 2021

Manufacturing authorisations and/or distribution authorisations of medicines and registrations of active pharmaceutical ingredients are no longer automatically sent in paper format by post to the marketing authorisation holder. 

The FAMHP is now sending these documents in digital format by e-mail. Marketing authorisation holders can still request paper versions.

A manufacturing or distribution authorisation consists of:

  • a first page with general information about the marketing authorisation holder (including name, administrative addresses and places of business),
  • a manufacturing authorisation (Manufacturing and Import Authorisation, MIA),
  • and/or a distribution authorisation (Wholesale Distributor Authorisation, WDA).

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