EMA released dedicated webpage for ISO IDMP

The Agency and the EU Regulatory Network are pursuing an open dialogue with industry to discuss aspects of implementing the ISO IDMP standards in the EU.

The Agency and the EU Regulatory Network are pursuing an open dialogue with industry to discuss aspects of implementing the ISO IDMP standards in the EU.
June 9, 2015

EMA has released a dedicated webpage for ISO IDMP.

 
Common standards, formats and terminologies should be used in the European Union (EU) to identify and exchange pharmacovigilance and medicinal product information. This is a legally binding requirement from the EU pharmaceutical legislation for Member States, marketing-authorisation holders and the European Medicines Agency (EMA).

An ISO IDMP Task Force has been established with the involvement of terminology organisations, software vendors and developers of medicinal products dictionaries or databases. The task force will be responsible for advising on the planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.

 
Friday 12th of June is the next face to face meeting at EMA with Industry´s working group on ISO IDMP implementation. Our Regulatory Information Director, Remco Munnik, will attend this meeting.

If you have any specific question, please contact us at: info@asphalion.com

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