API

• Do I need a licence?

  Please email pcl@mhra.gov.uk explaining your proposed business model. We will then consider and reply accordingly within ten working days 

• Can I use the front screen to make amendments to my licence?

  The front screen is for information only. Any amendments made will not be reflected on the licence.

• Can I amend my application once it has been submitted?

  Please contact pcl@mhra.gov.uk to see whether any amendments can be made at this point

• I’ve accidentally clicked to create a new submission against the wrong application how can I undo this?

  On the page displaying the incomplete application there will be a cancel button. Clicking this will cancel this submission but not any existing licence.

  

• My Previous Variation Has Been Approved But I Cannot See The Variation Button?

  Please contact pcl@mhra.gov.uk with the company name, number and submission type.

• How to submit your Annual Report for API’s

  When logged into the PcL Portal click onto ‘Account’ to see a list of all organisations you are named against. Click the ‘API’ button next to the organisation you wish to submit an annual report for.

  You will arrive at the ‘Company’ page showing previous submissions made. If you have a pending API submission you will have to wait for the current application to be completed before you can follow this process.

  Next to your API application, if an Annual Report is due then a button will appear on the right side saying ‘Annual Report’.

  

  After clicking on this button you will arrive at a screen asking if you are submitting an annual report with or with changes.

  

   

  No Variations

  If you select ‘No Variations’ (meaning the current API is current and up to date and requires no changes), then upon clicking ‘Continue’ you shall be taken to the declaration page. On this page you must attach a signed and completed declaration form. Upon clicking ‘Continue’ your application will be submitted to the MHRA.

  With Variations

  If you select ‘With Variations’ (Meaning changes are being made to details contained in your application e.g. Address, persons, products etc), then upon clicking continue you will be taken through to your application.

  In section 1.0 you should provide a brief summary of the changes being made to your application.

  Work your way through the application checking all information is correct and accurate. Once all changes have been made proceed to the ‘Overview and Declaration’ tab. On here you must attach a signed and completed declaration form.

  Upon clicking ‘Finish and Submit’ your annual report will be submitted to the MHRA for review.

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