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News & Press: News

Breaking News! Annex 1 Version 12 released for 3 month consultation process

21 February 2020  
Posted by: Tamsin Marshall
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Annex 1 Version 12

The European Commission (EC) have started a targeted consultation process on 20 February 2020 for commenting on Annex 1 version 12. The consultation period is 3 months.


Targeting is in the context of targeting comments around specific clauses of version 12 that are either significantly changed from the initial draft shared in the public consultation with revision as a result of comments received or concerns were expressed from the industry during the public stakeholder consultation.

Targeting is also the process of streaming comments through representative Stakeholders groups that are acknowledged by the EC as ‘Interested parties’ mainly formed of industry Not –for –Profit societies/ associations of which the PHSS are included and invited to participate in the commenting process. Across the commenting groups there is a cooperation initiative with a view, where possible, to harmonize comments or understand where non-alignment is present with a chance to align or agree to disagree but with knowledge that is the case before submission of comments.


Revision on Annex 1


Click here for more information

Click here for EMA Annex 1 documentation


PHSS Comments process will be released in 2 weeks. 


Should you wish to attend the Aseptic Processing and Contamination Control Workshop to attend the Annex 1 evening Discussion Forum then please click here to book - places going fast

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