Crown Copyright

Reproducing and re-using MHRA Crown copyright material.

Introduction
This information provides you with details about Crown copyright information and describes how you can apply for and get permission to re-use MHRA information, together with links to the application form for permission. It also details our commitment to openness and transparency in relation to information fair trading.
 
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About copyright and other intellectual property rights
All material created by the Medicines and Healthcare products Regulatory Agency (MHRA) is subject to Crown copyright protection. We control the copyright to our work (which includes all information, database rights, logos and visual images), under a delegation of authority from the Controller of Her Majesty’s Stationery Office (HMSO).

The MHRA authorises you to make one free copy, by downloading to printer or to electronic, magnetic or optical storage media, of any items featured on this website (excluding Agency logos) for the purposes of private research, study and reference. Any other copy or use of Crown copyright materials featured on this site, in any form or medium is subject to the prior approval of the MHRA.

In addition to the material listed above, MHRA can supply various other types of information and data packages, under licence, which can be used for more commercial purposes. For example we can provide the following information on granted product licences such as:

  • product licence numbers
  • legal status
  • product name
  • product licence holder
  • pharmaceutical form
  • pack size
  • active ingredient
  • packaging type
  • ATC classification

Details of how to obtain a licence are given below. Please contact MHRA to discuss other types of information you may be interested in obtaining.

Material from other organisations
You may not sell or resell any information reproduced to a third party without prior agreement.
The permission to reproduce Crown copyright protected material does not extend to any material on this site which is subject to a separate licence or is the copyright of a third party. In addition to our permission to reproduce material, separate authorisation to reproduce material from other organisations must be obtained from the copyright holders concerned. Wherever possible and appropriate we will indicate whether material is subject to third party copyright.

Our commitment to information fair trading
We are committed to trading in information fairly, and have received accreditation to the Information Fair Trader Scheme. Our Chief Executive has made a personal commitment to trading information fairly. Further information about the Information Fair Trader Scheme can be found on The National Archives (TNA) website (external link).

The commitment statement from our Chief Executive is available below:
Commitment of Chief ExecutivePDF file (opens in new window) (947Kb)

How to get permission to reproduce or re-use our material
Applications to reproduce our material should be made using the application form Word file (opens in new window) (446Kb) in writing, clearly stating the proposed use/re-use of the information, and should be sent to the MHRA at the address below:

MHRA Information Management 4-O
151 Buckingham Palace Road
Victoria
London, SW1W 9SZ
Fax: 020 3080 6353
E-mail: copyright@mhra.gsi.gov.uk

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 and commercially exploiting.

If you are not sure whether you need our permission, or have any questions in relation to filling in the form, please contact us for advice.

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

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 (together with the cost for re-use) for you to accept. Details of licensing terms and conditions together with costs, discounts and waivers are given below.

Once you have accepted the terms and conditions a formal licence will be drawn up and sent to you for signature, 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 to re-use Crown copyright material that:

  • 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 the Agency; 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 there is an intention to make it clear that that more up-to-date material is available.

The MHRA may also refuse to grant certain applications seeking to:

  • produce an exact copy (or a very similar copy) of one of their products or of a product they plan to produce within twelve months of the application;
  • produce a product that, in their opinion, is likely to affect safety;
  • use the material for advertising or promotional reasons.

If your application for re-use is refused, full reasons will be given. You will also have the opportunity to appeal against the decision (details of the appeals process can be found below). In all circumstances MHRA will, where possible, offer the applicant an alternative option.

Confidentiality
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.

Licences and terms and conditions
If the MHRA grants permission to use/re-use material, we will issue a licence with terms and conditions, which may involve the payment of a fee.

Licences, and conditions, are based on the template licences and standard terms and conditions for re-use on the OPSI website (external link) and will be prepared and adapted to suit each individual case (example of an MHRA licence). When we licence the use of our material, we treat all our applicants fairly and we will regularly review all of our licences to ensure fairness and transparency. We will send you full details of our terms and conditions, within the offer of a licence agreement, after we have processed your application.

All licensees will also be required to identify the source of the material they are re-using and its copyright status. A sample statement will be provided.

Charging for re-use
For most of the material produced by the Agency, the MHRA, authorises users of publications and visitors to the website, to make one free copy (excluding Agency logos) for the purposes of private research study or reference. For material of a more commercial nature, the MHRA will make a charge for its re-use, recovering the cost of producing and providing the document/information, and including a reasonable return on investment. As a Trading Fund, the MHRA must generate income from the sale and licensing of our services, products and information.

There are two 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% and the formula used for determining royalties due is:

Royalty rate x level of income generated by the product (after taking into account the booksellers’ or agents discount) x percentage of Crown copyright material in the publication, (as judged by the MHRA).

If there is no selling price, or the selling price is below the fair market value for similar products, we will work out royalties based on the same market value. The MHRA retains the right to acquire without charge, a copy of any value-added product openly marketed and sold, in order to supplement its archive.

Fixed fees
Fixed fees would normally be used in the following circumstances:

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

Fixed fees are payable once or at agreed intervals.

The level of fees charged by the MHRA are as follows:

  • £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 there is a requirement for regular updates to any information being re-used, then there will be additional charges for this service.

Internet/intranet use
The charging arrangements for the re-use of Crown copyright material originated by the MHRA, on an internet/intranet site, will be subject to separate negotiation, and will depend on intended use.

Bespoke services
Bespoke services will be priced on a project-by-project basis, dependent 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.

Discounts and waivers
Exceptional concessions may be granted to organisations or individuals for academic or educational purposes. Where a concession is granted to an organisation or individual, 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 any fees against the value of the benefit. For example:

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

For further details please email copyright@mhra.gsi.gov.uk

Copyright infringement
Under UK law copyright infringement is a criminal offence. Whilst 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. It is our aim to sort out any problems amicably but we have the right to take any necessary legal action to protect our interests and the interests of our licensed customers.

Complaints
If you are dissatisfied with the response from the Agency to any aspect of our licensing activity you may seek an internal review of that decision. A senior Agency official, who has not previously been involved with your request, will undertake that review. All complaints should be made in writing and sent to:

Mrs Kirsten Padgham
MHRA Central Complaints Officer
Medicines and Healthcare products Regulatory Agency
5.M 151 Buckingham Palace Road
Victoria
London, SW1W 9SZ

A standard complaints form is available:
MHRA complaint form

We will let you know we have received your complaint within 2 working days. We aim to resolve all copyright-related complaints within twenty working days.

If you are not satisfied with our response, you should contact our Licensing Regulator at the following address: The National Archives, Kew, Richmond, Surrey, TW9 4DU.

Infringements
If copyright material is used without permission, there is a breach of copyright. Under UK law copyright infringement is a criminal offence. Under our delegation of authority from HMSO, the MHRA is authorised to take the lead on all infringements of its material.

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


Page last modified: 30 April 2013