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1 Special mail 5 The MHRA updating servicefor medicinesSafeguarding public healthMailMedicines and Healthcare products Regulatory AgencySpecial mail 5 Guidelines on submission ofapplications to the MHRAS pecial mail 5 mail is published bimonthly by theMedicines and Healthcare productsRegulatory Agency (MHRA), MarketTowers, 1 Nine Elms Lane, LondonSW8 : 020-7084 2000 Fax:020-7084 Ed ScullyProduction: Ronke OmotayoItems in mail give general guidanceand must not be treated as acomplete and authoritative statementof the law on any particular of the Medicines Act and ofthe Orders and Regulations madeunder the Act are available from TheStationery Office 1360-8738 Crown Copyright 20062 New ways of working at MHRAMailThe MHRA updating servicefor medicinesSpecial mail 5 IntroductionTypes of submission coveredSending submissionsStructuring data on diskPosting disksLabelling disksContactsAnnex A344711121213 Special mail 53 New ways of working at MHRAC ontinued on page MHRA recently completed the last phase of

2 Its Sentinel Programme. TheSentinel Programme was a major redesign of the information managementsystems (IMS) that support the MHRA s programme started in January 2003 and had the following objectives: Enhance and accelerate decision-making processes. Further improve the quality of work carried out by the Agency. Improve operational efficiency of the Agency. Build an electronic interface to industry stakeholders for electronic applications andcommunications. Establish an information infrastructure that can evolve to meet the changing needs of theAgency and its customers. Develop New ways of working for the introduction of Sentinel was accompanied by a major business reorganisation which included thecreation of an MHRA information processing unit (IPU).

3 The objective of the IPU is to receivesubmissions from pharmaceutical companies and quickly input the core details of the submission intothe Sentinel system for further assessment by other business areas. The more efficiently the IPU canprocess submissions the quicker the submission will be available for assessment. The efficiency ofthis process is critically impacted by the format and quality of the data submitted by companiesThe purpose of this document is to define a standard approach to sending submissions to the MHRAto assist pharmaceutical companies in preparing submissions in a manner that ensures that theMHRA can process their submission as efficiently and as quickly as possible.

4 It brings togethertechnical advice that we previously published in Special Mails 1 to 4, updated and expanded requirements detailed in this mail will apply from 15 August 2006 Important note on eCTD submissionsThe Sentinel system has been designed to support new market authorisation (MA)applications and variations in the eCTD format. This format allows automatic datauploading into Sentinel and maximum processing efficiency. We recognise, however, thatmany companies are not yet ready to create submissions in the full eCTD format. Thisdocument does not, therefore, consider eCTD submission; it details the procedures to befollowed until the company is able to submit in the eCTD format.

5 Companies should beworking towards eCTD compliance. Please note that all European Union (EU) memberstates are committed to be able to accept eCTD submissions from 2009. MHRA intends to make eCTD submission a National mandatory requirementThe exact date will be announced subsequent to discussion with industry representativebodies. It is likely this will be a phased approach with the requirement to submit applicationsfor new MAs introduced in the first instance. Detailed guidance on eCTD submission will you are planning to submit an eCTD application or would like to discuss the issues involvedin moving to this format, please contact David Wheeler on 020 7084 2350 mail 54 Continued from page 3 New ways of working at MHRAC ontinued on page 52.

6 Types of submission coveredThe following submission types are covered by this document Market authorisations (MAs) (National, mutual recognition (MR) and Decentralised Procedure)(including initial applications, variations, renewals, change of ownership and cancellations). Parallel Import licences (including initial applications, variations and change of ownership). Homoeopathic medicines. Notified Bodies. Clinical trials. Periodic safety update reports (PSURs). Active substance (drug) master files (ASMFs).This document discusses how to send documents in support of applications to MHRA. Applicants shouldconsult detailed specific guidance for information on the content of Sending paperThe Sentinel system is designed to allow the MHRA to work in a fully electronic manner.

7 Paper submissionsincur a significant handling and scanning overhead before they can begin to be processed and MHRA will accept paper submission but can not guarantee that they will be processed to the sametarget timescales as submissions received via the MHRA portal or on PortalThe MHRA s preferred route for receiving submissions is via the MHRA MHRA Portal went live in December 2005 and we want it to become the de facto method by whichcompanies interact electronically with the Agency. The Portal provides companies with an easy-to-use,secure and fully operational tool to manage the complete application life cycle of all business the Portal can be used for submissions concerning product licensing, parallel importlicences and export certificates.

8 You will be able to submit applications, correspondence, and data throughCompanies are strongly encouraged not to submit applications on sent via the MHRA Portal or on disk are likely to be processed to aquicker timescale than paper mail 55 New ways of working at MHRAC ontinued from page 4 Continued on page 6the Portal. We will communicate back to you via the Portal with requests for further information or the issueof an the Portal can not be used for submission concerning homoeopathics, notified bodies, clinicaltrials, process licensing, PSURs and active substance (drug) master files (ASMFs). Companies areencouraged to send submissions covering these areas on disk (see below).

9 The MHRA are consideringexpanding the Portal service to include additional submission types and customers will be informed whenthese are promote the introduction and uptake of electronic working, the MHRA have designed a comprehensive setof application forms using the new Adobe intelligent form technology. As well as producing a form that looksvery much like the original paper form it incorporates validation routines using Sentinel Web Services. Thisgreatly assists in ensuring that accurate data is uploaded into the Sentinel Portal supports all file formats and enables applications from simple PDFs, electronic CTDs to fulleCTD applications to be with supporting data of up to 100MB (zipped) can be uploaded directly onto the with supporting data over 100MB should have the supporting data copied onto CD or DVD (seeguidance below for how to submit a CD or DVD) and submitted on disk.

10 The data should be structured as perthe relevant submission type (see below). The Portal will issue a ticket number which should be outline, an application form is downloaded from the Portal, completed using Sentinel Web Services, datafiles attached and the completed application submitted via the will need to register and attend an MHRA training course before using the Portal. Registrationdetails can be found at further information please e- mail : DiskCompanies are encouraged to send submissions via the MHRA Portal (see above). If this is not possible, oran applications is too large (> 100 MB zipped) to be submitted via the Portal, the MHRA will acceptsubmissions on disk.