What is emc regulatory publishing tool?
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      2. New emc regulatory publishing tool
      3. What is emc regulatory publishing tool?

      What is the emc regulatory publishing tool?

      emc Regulatory (1)

       

      The emc regulatory publishing tool is an online system that allows you to manage your products and content, such as Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs), that are published on the electronic Medicines Compendium (emc)

      emc publisher allows you to add, update or retire (remove) your documents.


      Process overview for SmPCs

      • You submit a New or Updated SmPC.
      • We convert the SmPC so that it can be displayed on our websites as ePI (electronic product information) in FHIR.
      • We then QC your SmPC thoroughly, correcting any conversion errors.
      • You check your SmPC and either correct any errors yourself or we can correct formatting issues for you.
      • You do a final review and approve your SmPC.
      • Your document is published on emc website.

      Please Note 📝

      Whilst your SmPC is being processed it can only be seen by emc data managers in your company. Only approved SmPCs will appear on the emc.

       

      Process overview for PILs

      • You submit a New or Updated PIL in PDF format.
      • You can opt to pre-approve the PDF PIL if you choose.
      • We then QC your PIL and if it passes, it will be published on emc website within one working day (without pre-approval we will send the PIL back to you within one working day for final review and approval).
      • Your PIL is published on emc website.

      Please Note 📝

      Whilst your PIL is being processed it can only be seen by emc data managers in your company. Only approved PILs will appear on the emc.

       

      Process overview for ePILs (X-PILs)

      • You submit a PDF PIL and then you can request an ePIL to be created. This is a text only PIL with no images, tables or graphs. You can provide alternative text to replace the tables, images or graphs if they contain critical information.
      • We convert your approved PDF PIL into XML so that it can be displayed on our websites in HTML. We produce a text only ePIL without images, tables or graphs.
      • We then QC your ePIL thoroughly, correcting any conversion errors.
      • You check your ePIL, and we can correct formatting issues for you.
      • You approve your ePIL.
      • Your ePIL is published on emc website.

      Please Note 📝

      Whilst your ePIL is being processed it can only be seen by emc data managers in your company.

       

      If you have any questions please contact us servicedesk@datapharm.com