What to consider when adding an API CEP to a dossier in Jordan

Is there a change to the main synthetic route when compared to that already approved?

Is there a change to the impurity profile that requires qualification?

Is there any change to the physiochemical properties that impact bioavailability?

Is there any change to the specification from that already approved?

If the answer to each of these questions is “No”, the change is determined to be notifiable.

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In the case where the main synthetic route is different to that already approved, with no change to the impurity profile, physiochemical properties that impact bioavailability or specification, the change requires regulatory approval.

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The documents required to support the change are the same with one exception. For the notifiable change, the Marketing Authorisation Holder should provide a declaration that the main synthetic route, quality control procedures and specifications are the same as those already approved. The declaration should include a present and proposed table with API route of synthesis from both API manufacturers. For the change requiring regulatory approval, provide a comparative table with API route of synthesis from both API manufacturers.

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The other documents required are:

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·???????? A Cover Letter requesting the change

·???????? A letter from the Marketing Authorisation Holder which includes details of the change, name and address of the proposed API manufacturer and implementation date

·???????? Comparative table of physiochemical properties for current and proposed API manufacturers

·???????? Comparative table with specification and impurity profile for present and proposed API manufacturers

·???????? Finished Product Certificate of Analysis for product manufactured with API from proposed manufacturer

·???????? Declaration that there is no effect on the Finished Product quality with reference to supporting stability data to provide scientific justification

·???????? Copy of the current CEP of the proposed API manufacturer

·???????? Comparative table for batch analysis data from at least two batches for both present and proposed API Manufacturers

·???????? Certificate of Analysis of API from proposed API manufacturer

·???????? Certificate of Analysis of the API form the Finished Product manufacturer

·???????? Copy of API specification from proposed API manufacturer*

·???????? Any amended sections of the dossier

·???????? Closed part of DMF or declaration

·???????? Approval letter for change in reference country

·???????? Updated m3 sections as applicable

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*Note: if this specification is different to that of the current API manufacturer, an additional change submission is required.

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Prior to submitting a CEP from a new API manufacturer in Jordan, the applicant should consider the availability of the relevant Certificates of Analyses and Stability Data to ensure timely submission and approval.