The authors of the article describe the challenges and learnings in the process of refactoring internal system for tracking the records of  marketing  authorization  procedures and  medicinal  product  database in  the  Agency  for  Medicinal  Products  and  Medical  Devices   (HALMED)    in   order   to   comply   with   ISO   IDMP   (International Organization for Standardization, Identification of  Medicinal  Products)  standards. 

The    implementation    process    is    very demanding  for  the  industry,  the healthcare  organisations  or  the regulators.  It  requires a  deep  assessment  of  all  internal  business processes that rely on medicinal product data and an analysis  of  external stakeholder’s  dataset  needs  so  that  a master   data   set   can   be   defined;   Organisations   need   to   become acquainted with the ISO IDMP data models and the EU IDMP Implementation  guide.  One  of  the  first  decisions to be made is whether an entirely new system (off-the-shelf  or  custom  made)  needs  to  be  implemented  or  whether  the  old  system  can  be  refactored.  HALMED opted for  the refactoring of  the  existing system.

HALMED’s  plans  include  the   medicinal   products   data   model   reconstruction,   user   interface adaptation, changes on the synchronization processes and establishing connection with SPOR (Substances, Products, Organisation and Referentials) data management services. In a response to the introduction of the ISO IDMP set of standards, the  EMA (European  Medicines  Agency)  initiated the SPOR data management service project, with the objective to provide the  framework  for  standardization  and  structured  data  in medicinal products description.

The article will be presented to the public  during the eTELEMED 2022 conference on Thursday, June 30th, from 15:45 – 17:45 by Maja Fatiga