Wednesday, March 10, 2021

PPP regulation after the UK transition period

HSE acknowledges confusion or concern was caused by the latest update provided on 11 February

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HSE eBulletin

GB renewal: 30 month deadline for supplementary dossiers

HSE has received feedback that confusion and concerns were caused by the latest e-Bulletin provided on 11 February, relating to the 30 month deadline for supplementary dossiers supporting active substance renewals, which is part of the retained GB legislation.   

 

In that update we stated the legal deadlines in response to questions raised.

 

We regret any confusion or alarm caused and recognise that it did not acknowledge the realities of moving to establish the GB Active Substance Renewals Programme, which means that at this stage we cannot specify in detail what the requirements of the associated supplementary dossiers will be. HSE acknowledges that applicants will need time to assemble the necessary GB specific dossiers.

 

Be assured HSE is seeking to minimise the action required to meet this legal requirement pending the longer term Programme being developed. Further clarification will be provided as soon as possible.

 

 

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