Support in Management Services for SPOR for new EMA requirements

Do you have all your organisation information up to date in SPOR? EMA has recently communicated that the use of Organisation Management Service (OMS) in the eAF for CAP will be mandatory.

Do you have all your organisation information up to date in SPOR? EMA has recently communicated that the use of Organisation Management Service (OMS) in the eAF for CAP will be mandatory.
July 27, 2021

Do you have all your organisation information up to date in Substances, Products, Organisations and Referentials (SPOR) database? ​

EMA has recently communicated that the use of Organisation Management Service (OMS) in the eAF for CAP will be mandatory. This means that all companies must manage their information in order to be identified in the database in the multiple languages offered by SPOR.

After an extension of the original deadline, applicants and Marketing Authorisation Holders (MAHs) of human and veterinary medicinal products have until the end of September, 2021, to register new sites in the OMS section of SPOR, to meet the requirements of EMA.

What organisational data needs to be in the SPOR database?​

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.​

​This information is intended to keep the SPOR database, which is open to the public, up to date.

Some of the items requested by EMA to be updated or registered in SPOR are:

  • Organisation names ​
  • Location address details​
  • Contact details for location (Email, address, telephone number)

National Procedures Information Update in SPOR

Even though there are no official dates for National Procedures, it is recommended companies start registering their information as soon as possible in SPOR.

It is recommended that you keep up-to-date information about organisations that apply for marketing authorisations for human and veterinary medicinal products, either locally or in various countries of the European Union.

If you require any support registering or updating information in SPOR do not hesitate to contact Asphalion: info@asphalion.com

More information at eSubmission Ema website (http://esubmission.ema.europa.eu/eaf/index.html)

 

 

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