08 October 2019
The EU has re-published the recently revised Chapter 3 and Chapter 5 (we reported) and has made modifications regarding the transition period for the introduction of toxicological evaluations of products in multipurpose facilities. The two new documents carry the date 23 January 2015. The date of validity remains the 1 March 2015. The document now comprises a description of a stepwise procedure for the introduction of a risk management system to evaluate whether products need to be manufactured in dedicated or can be manufactured in multipurpose facilities. The procedure matches with that of the associated EMA "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities". That means that starting with the 1 June 2015 the new requirements are valid for new products which are evaluated regarding the manufacture in dedicated or multipurpose facilities for the first time. For products already manufactured in multipurpose facilities the new regulations are valid from 1 December 2015.
Hence the EMA Guideline is now explicitly mentioned, even if only in footnote 1 of the new chapters. In the draft of the two chapters this reference was still included, in the final versions references to the EMA Guideline were completely omitted.