In this respect, EMA has established a SPOR portal that provides various data management services including viewing, searching and exporting SPOR data (an important feature to import SPOR data into other documents/systems) in order to allow Marketing Authorization Holders (MAHs) to register and enter or update their related SPOR data.
What do Marketing Authorization Holders have to do at this stage?
First of all, MAHs with authorized MA(s) need to check their data in the Article 57 database (xEVMPD4) to ensure it is accurate and up to date.
Subsequently, in order to maintain an effective linkage of the entire European medicines regulatory network and pharmaceutical industry, EMA has made it mandatory for applicants and MAHs of medicinal products to complete corporate information (i.e. organization names, location and address details, contact information for location: Email, address, telephone number, etc.).
On 1st November 2021, for Centrally Authorised Products (CAPs), the use of OMS data in the current electronic application forms (eAF5) became mandatory. This means that when filling out one of the (fillable) EU electronic application forms (e.g., electronic Application Form (eAF) or electronic Variation Application Form (VAF)), OMS data must be directly imported from the SPOR portal into the fillable forms provided and it is only possible if the applicant had previously registered on the SPOR portal and entered the related data.
Mandatory use of OMS for National Authorized Products (NAPs) is still under discussion. However, with the progressive replacement of the current eAF forms with web-based application forms over the next year, OMS will de-facto become a requirement for NAPs as well. This is because web-based application forms are the same for CAPs and NAPs by design. Even though there are no official dates for National Procedures, it is recommended that companies begin to register their information as soon as possible in SPOR.