Module 12 2019

Mandatory data July 2012 i. A description of the (invented) name of the medicinal product ii. A description of the therapeutic area(s), which shall include: (a) ATC Code for the medicinal product iii. Details of the marketing authorisation holder iv. Details of the marketing authorisation and the marketing status, which shall include: (a) Marketing authorisation procedure (b) Country of marketing authorisation (c) Marketing authorisation number (d) Authorisation/renewal date (e) Marketing authorisation status (f) Mutual-recognition procedure number or national MA number (g) Orphan drug designation (h) Date of withdrawal/revocation/suspension of the medicinal authorisation

The Organisation for Professionals in Regulatory Affairs