Guideline on shared facilities coming into effect 01 June 2015

 

 

 

  • December 1st 2015 : For medicinal products introduced for the first time into shared manufacturing facilities.

  • June 1st 2016 : For manufacturers of products for human use already produced in shared manufacturing facilities (unless existing arrangements scientiffically justified) including those who manufacture human and veterinary medicines using shared manufacturing facilities.

  • June 1st 2017 : For manufacturers solely producing products for veterinary use (unless existing arrangements scientiffically justified) .

To fullfill guideline on shared facilities requirements within the deadlines imposed, we elaborate some customized PDE monographs for all products concerned. Access directly to our database which contains more than 1,000 PDEs already developed.

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