MHRA Special Mail 5

Special Mail 5 deals guidelines on submission of applications to MHRA.

It covers:

1. Types of submissions covered
2. Sending submissions
3. Structuring data on disk
4. Posting disks
5. Labelling disks

1. Types of submissions: 

• 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 should consult detailed specific guidance for information on the content of submissions.

2. Sending Submissions: Provides information if the submission is

• Paper
• MHRA Portal
• On dsik
• Requirements for file formats and Guidance on preparing PDF documents

3. Structuring Data on Disk: Provides information on Structuring Data on Disk for -

• New market authorisation applications (National, MR and Decentralised Procedure)
• Variation applications
• PLPI applications
• Homeopathic applications
• Active substance (drug) master file (ASMFs)
• Notified body applications
• MA renewals
• Periodic safety update reports (PSURs)
• Clinical Trial Applications
• Responses to requests for information (RFIs) sent by the MHRA

4. Posting address: The address to be used for sending disks to the MHRA will depend on the type of submission. All disks should be sent to the address below ensuring the area number that relates to the submission type is quoted.

Information Processing Unit
[Please see list below **]
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ

**Address to the following area code depending on the type of submission:

• Area 1 New National Market Authorisation Applications and responses to related RFIs
• Area 2 MR and Decentralised Procedures Applications and responses to related RFIs
• Area 3 Variation Applications and responses to related RFIs
• Area 4 MA Renewals, PSURs and responses to related RFIs
• Area 5 PLPI, Homeopathic and Notified Body Applications
• Area 6 Clinical Trial Applications and related responses to RFIs
• Area 7 Active Substance (Drug) Master Files
• Area 8 Centralised Applications
• Area 9 Patient Information Updates

5. Labelling disks: Each disk should be labelled in the following manner:

• PL number or EudraCT number.
• For portal applications only  the portal ticket number should be quoted.
• Description of contents (eg. variation, MA application, PSUR, response to RFI, etc.).
• Company name.
• Date sent

Special MAIL 5 should be read in conjunction with the Frequently Asked Questions.

Further information:

1. Special Mail 5

2. Special Mail 5 Frequently Asked Questions