Guidance

Reproduce or re-use MHRA information

Published 26 August 2015

Get permission to reproduce or re-use our material

Fill out the appropriate application form, clearly stating the proposed use/re-use of the information and email it to copyright@mhra.gov.uk or post it to:

MHRA Information Management
10 South Colonnade
Canary Wharf
London
E14 4PU

Re-use in copyright terms is the handling of information in a way that was not originally intended. The acts restricted by copyright are:

• copying
• adapting
• developing
• adding value
• broadcasting
• commercially exploiting

If you are not sure whether you need our permission, or have any questions in relation to filling in the form you should email copyright@mhra.gov.uk for advice.

We try to process all applications and provide you with a decision within 20 working days of receiving your application. If all reasonable efforts have been made but details of the decision cannot be confirmed within 20 days you will be informed as soon as possible.

All information provided in applications to use/re-use information will be treated in confidence. Your personal data will not be made available to others for any purpose.

Granting permission to re-use MHRA information

If your request is granted (and a formal licence is not required) you will receive a letter granting permission to reproduce the material in question.

If you are granted permission to reproduce MHRA material and a formal licence is also required, you will receive licence terms and conditions and the cost for re-use).

Once you have accepted the terms and conditions a formal licence will be drawn up and sent to you to sign, together with a fee request for payment.

Exceptions

In principle, all information can be licensed for legitimate re-use by an applicant. However, we may refuse to grant certain applications if it:

• is restricted by legislation, for example the Data Protection Act and Freedom of Information (FOI) Act
• is protected by the rights of another organisation and that organisation has not given their permission for re-use
• is constrained in practice, by limitations of current technology
• may damage the reputation of MHRA; for example to re-use information in a way that targets vulnerable groups
• is intended to be used in a way that could mislead the public
• has been superseded or is out of date, unless you make it clear that that more up-to-date material is available

We may also refuse applications that want to:

• produce an exact copy (or a very similar copy) of 1 of our products where it would cause customers to be confused as to who published the product
• reproduce material that could affect our ability to meet our targets
• produce a product that, in our opinion, is likely to affect safety
• use the material for advertising or promotional reasons

Licences and terms and conditions

Licences, and conditions are based on the template licences and standard terms and conditions for re-use on the TNA website which will be prepared and adapted to suit each individual case.

You will be required to identify the source of the material you are re-using and its copyright status. We will provide you with a sample statement.

Fees

For most MHRA material we authorise users to make 1 free copy (excluding MHRA logos) for the purpose of private research, study or reference. If the material is of a more commercial nature, we will charge for its re-use. There are 2 kinds of fees - royalties and fixed fees.

Royalties

A royalty is a fee that is linked to the amount of income generated from the sale of a product. It is generally payable annually. Our royalty rate is 10%.

Fixed fees

Fixed fees would normally be used:

• if the material is re-used in a way that does not involve the offer for sale of a product or service to a customer
• if the material represents a small proportion of a large database product

Fixed fees are payable once or at agreed intervals.

The fees are:

• £500 minimum charge for any information up to 20 pages
• £1000 between 21 and 50 pages
• £2000 between 51 and 100 pages
• £500 for every 100 pages thereafter

If you need to make regular updates to any information being re-used there will be additional charges for this service.

The charging arrangements for the re-use of materials for digital purposes (websites, intranets, social media) will be discussed separately and will depend on intended use.

Bespoke services will be priced on a project-by-project basis, depending on the nature of the services and the requirements of the customer. However within any specific UK market sector, the price for identical products and services will be the same.

Exceptional concessions may be granted to organisations or individuals for academic or educational purposes. Where a concession is granted, the same concession will be granted to like organisations or individuals in like circumstances.

If we benefit from the re-use of our information we may consider offsetting fees. For example:

• if you provide us with new information that we can use to improve our products
• if your product or service improves safety

Email copyright@mhra.gov.uk for further details.

Copyright infringement

Under UK law copyright infringement is a criminal offence. While we actively encourage the licensed use of our material, we will protect it against unlicensed use. We constantly monitor the use of our material by other people and organisations. We will pursue any cases where material has been used/re-used without our permission and have the right to take any necessary legal action to protect our interests and the interests of our licensed customers.

All infringements of MHRA originated Crown copyright and database rights should be brought to the attention of the MHRA.

Complaints

If you are dissatisfied with the response to your application from MHRA to any aspect you can ask for an internal review of the decision. A senior MHRA official who has not previously been involved with your request, will carry out the review. All complaints should be made in writing and sent to:

Central Complaints Officer
Business Planning and Corporate Management Team
10 South Colonnade
Canary Wharf
London
E14 4PU

We confirm that we have received your complaint within 2 working days. We aim to resolve all copyright-related complaints within 20 working days.

If you are not satisfied with our response, you should contact our licensing regulator:

Information Commissioners Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF