Declarations related to R4 and R6 changes

Note for the attention of applicants

(05/03/08) According to the Guideline on requirements for revision/renewal of Certificates, the condition to apply for a minor revision related to a change or addition of a manufacturer of a starting material or intermediate (R4) or to a change or addition of a manufacturing site (R6) is that the route of synthesis of the concerned materials should be exactly the same as that already approved – including all solvents, reagents, catalysts, raw materials, starting materials and intermediates (including the culture broth and precursors for fermented products). When the route of synthesis of the concerned materials is modified, a request for a major revision should be submitted.

When assessing applications for minor changes, i.e. R4 and R6, it has been noticed that the provided declaration that the synthetic route of the starting material, intermediate or final substance unchanged is often invalid as indeed modifications are observed in the route of synthesis compared to the approved one.

To allow EDQM to run the procedure smoothly and to respect deadlines, any request received after 31 March 2008, which includes such an invalid declaration, will be rejected at any time (at receipt or at the stage of the assessment), and the applicant will have then to apply again for the relevant kind of revision.