(Updated Feb 2008)
I subscribe to MedDRA/J.
How do I communicate with the Japanese Maintenance Organization
(JMO)?
The Japanese Maintenance Organization (JMO) for MedDRA may
be contacted through their helpdesk via email at
Helpdesk.jmo@sjp.or.jp.
Who should subscribe to MedDRA?
These industries will benefit from MedDRA:
- Pharmaceutical companies
- Biotechnology companies
- Device manufacturers
- Regulatory authorities
- CROs
- System developers
- Other support service organizations
What
types of subscriptions are available?
Three types of MedDRA subscriptions are available for purchase
from the MSSO, Basic Service, Core Services, and
System
Developer.
What is defined as basic service subscription?
A basic subscription is reserved for nonprofit medical libraries, educational institutions, and direct patient care providers (e.g. hospitals). A basic subscription is available as a renewable yearly subscription. With a basic subscription, MSSO provides:
- MedDRA terminology via internet file download in all available EU language translations including English
- MedDRA supporting documentation via internet file download, including:
- What's New Document
- ASCII File / Conseq File Documentation
- MedDRA Introductory Guide
- SMQ Introductory Guide
- and more
- All scheduled updates
- User Group membership
- Help desk support, M-F 0900-1700 EST
Change Request service is not included with the basic subscription. There
are additional purchasable services
available through the MSSO.
Why
must both CRO and a client company have a subscription to MedDRA?
It is the intent of the ICH , the creators of MedDRA, and the IFPMA, the holders
of the property rights to MedDRA, that all pharmaceutical companies have a
current MedDRA license in order to code, analyze, report, or hold MedDRA
coded data. CROs who code, report, or hold MedDRA coded data must also have a current license to MedDRA. Otherwise the sharing of data violates the MedDRA licensing agreement created by the IFPMA regarding the distribution of MedDRA to another party.
What are the products of a core services
subscription of MedDRA?
A core subscription is available as a renewable yearly subscription. With a core subscription, MSSO provides:
- MedDRA terminology via internet file download in all available EU language translations including English
- MedDRA supporting documentation via internet file download:
- What's New Document
- ASCII File / Conseq File Documentation
- MedDRA Introductory Guide
- SMQ Introductory Guide
- and more
- All scheduled updates
- User Group membership
- Help desk support, M-F 0900-1700 EST
- 100 change request allocation per month.
Change Requests are included with the Core subscription. There
are additional purchasable services
available through the MSSO.
What is defined as system developer service?
The system developer sublicense is reserved for organizations that develop software products that utilize MedDRA. The use of MedDRA by system developers will be for testing the terminology with their developed products and not for classification, analysis, and communication of data. With a system developer subscription, MSSO will provide:
- MedDRA terminology via internet file download in all available EU language translations including English
- MedDRA supporting documentation via internet file download including:
- What's New Document
- ASCII File / Conseq File Documentation
- MedDRA Introductory Guide
- SMQ Introductory Guide
- and more
- All scheduled updates
- Help desk support, M-F 0900-1700 EST
- User Group membership
Change Request service is not included with the System Developer sublicense.
There are additional purchasable
services available through the MSSO.
My corporation has purchased
a subscription to MedDRA. Can copies be made of MedDRA or can MedDRA
be shared with other parts of the company or corporation?
Yes. MedDRA subscriptions are sold on an enterprise-wide basis, not by the number of seats. Your MedDRA subscription may be shared with all employees of your company/organization and their wholly-owned subsidiaries. There is no limit to the number of copies you may make for your company's use.
The subscription point of contact listed on the Subscriber
Agreement is responsible for ascertaining who may receive
copies or share capabilities of MedDRA within the organization
and distributing User ID, Passwords, Change Request ID, and / or Unzip passwords to those that may need them to access information.
What is the help desk support
level provided to subscribers?
The MSSO help desk will provide year-round coverage help desk support in English for subscribers. The help desk will answer questions regarding MedDRA MSSO products and services to including but not limited to: subscription information, MedDRA scope and structure, MedDRA versions and release schedules, general terminology questions, User Group information, change request information including maintenance rights, supplemental terms/changes information.
What
are the annual subscription rates for a MedDRA subscription?
Services are available by purchasing a renewable subscription based on annual company revenue. See current prices in the MedDRA Annual Subscription Rates (Prices are in US dollars; all prices quoted are exclusive of and do not include sales, use, value-added, and/or withholding taxes, customs/duties, and international bank transfer fees, where applicable).
Who
decides how much a MedDRA subscription costs?
The pricing structure for subscriptions to the MedDRA terminology which the MSSO follows was collectively determined by the ICH , the creators of MedDRA, as well as the IFPMA who hold the property rights to MedDRA.
What is the bank transfer
fee reference on the subscription invoice?
If you are making a wire transfer through an international bank,
a fee is charged for the transaction. You are required to include that amount
in addition to the subscription total on the invoice. Failure to include the appropriate wire fee charge may interrupt the processing of your MedDRA subscription.
How do I become
a MedDRA subscriber?
You can contact the toll free number 877.258.8280 (accessible worldwide) or the USA direct number 703.272.5505, fax to USA direct number 703.272.5635, or send an email to MSSOsubscribe@ngc.com. When the MSSO receives a signed subscriber agreement, you will be invoiced for your subscription via email. Be sure to include a copy of the total annual revenue for your company so you can be appropriately invoiced. Payments must be made in US dollars; checks and wire transfers are accepted forms of payment; we do not accept credit cards. Upon receipt of payment, notification of subscriber information will be provided to the designated point of contact to download the MedDRA zipped files from the MSSO Web site. Subscribers are immediately eligible for services such as the help desk and change requests, where applicable.
What
is the effective period of a MedDRA subscription?
A subscription is effective for twelve months commencing with the
first day of the month following the MSSO's receipt of payment of
the subscription invoice.
How
will I be billed for the MedDRA subscription?
You will be emailed an invoice for your subscription following the MSSO's
receipt of the signed subscriber agreement and financial statement
of total annual revenues.
***Important***
MedDRA ACCESS TO ELECTRONIC FILE DOWNLOAD WILL NOT BE PROVIDED
UNTIL PAYMENT IS RECEIVED BY THE MSSO.
The invoice is payable upon receipt. Payments must be made in US Dollars. Checks and wire transfers are accepted forms of payment. We do not accept credit cards. If the wire transfer is coming through an international bank, please be sure to include any bank transfer fees with your payment.
How will
subscription renewals be handled?
Subscription renewal notices are automatically sent out from
the MSSO approximately 30-45 days prior to subscription end date. If the MSSO is able to obtain a subscriber's financial information online, an invoice will be automatically emailed in the renewal notice to the billing point of contact on file.
However, if the subscribing company is privately held, a response is REQUIRED from the subscription point of contact providing the necessary financial information before the MSSO can invoice for the MedDRA subscription renewal period. If the subscriber does not wish to be renewed, notification must be received in writing by the MSSO at least 30 days prior to the subscription end date by emailing mssohelp@ngc.com.
If
I subscribe midyear, how many updates of MedDRA will I receive?
The subscription year will start when payment is received. You will
receive one full year of updates based on your subscription timeline. MedDRA updates are bi-annual with the first release in March and the second in September.
If
a subscriber upgrades from a basic subscription to a core subscription, what is the cost to
upgrade?
Your company will be credited a prorated amount on the basic subscription for the remaining months, and the core services subscription will be treated as a completely new transaction. The one-year subscription will start the first of the month following the MSSO receipt of payment for the new subscription. Core subscriptions for prior Basic subscribers is capped at a Core 1 rate.
Are
the release dates of MedDRA consistent from year to year with March
and September being the release months?
Yes. MedDRA is always released on the 1st of March and September; if the 1st falls on a weekend, then the downloadable files are posted the following business day.
In what
language is the terminology available?
The terminology is available in Czech, Dutch, English, French, German, Italian, Portuguese, and Spanish to all subscribers via doanload.
A Japanese version of the terminology is available as a purchasable service item for $850 USD. This translation is not available as part of the MedDRA subscription.
Where can I find the translations on the web site in order to download them?
Subscribers may download translations of MedDRA on the Download section of the web site in the MedDRA Terminology area: http://www.meddramsso.com/Translations/translationDownloads.htm
What information is needed by the subscriber in order to download translations?
Subscribers may download translations of MedDRA as long as they have their User ID, Password, and the Unzip password. The MedDRA Help Desk only gives this information to the designated point of contact on the subscription; other members are directed to get subscriber specific information from their company's point of contact.
What
are the maintenance rights for a core subscriber?
The maintenance rights available to a core services subscriber
are as follows:
- 100 routine change requests per month
- Supplemental terms
- Explanation of change request rejections
What differentiates a core subscriber
from a basic or a developer subscriber?
Each core subscriber receives a User Identification Number (User ID), a Password, and a Change Request Identification Number (CR ID). Both the User ID and Password are required for help desk support and to access the restricted sections of the MSSO Web site. For access to the Subscriber Area of the web site, the User ID is the “USER NAME” and the Password is the “PASSWORD.” The User ID and CR ID are required to submit change requests and to update your subscriber profile online. When entering either the User ID or CR ID, be advised that they are case sensitive.
Each basic or developer license subscriber receives a subscriber User ID and a Password to be used to download the MedDRA translation files, to update their subscription profile, or to register for the MedDRA Forum. When accessing the web, the assigned User ID is the “USER NAME” and the Password is “PASSWORD.” Basic and developer license subscribers do not receive Change Request Identification Numbers (CR ID).
Please note that both the User ID, Password, and the CR ID will be reassigned when the point of contact changes or when the subscription is renewed.
I have lost or forgotten my Password and/or Change Request Identification Number. How do I get another one?
Only the main Point of Contact (POC) on the Subscription Agreement can request a new Password and/or Change Request Identification Number. This must be done in writing – email or fax is acceptable.
Email: mssohelp@ngc.com
Fax: 703.272.5635
When the MSSO receives your request, a new Password and Change Request Identification Number (CR ID) will be assigned to the subscribing organization and emailed to the main point of contact.
All changes to Passwords, or CR IDs will be take effect immediately. Any requests from members of a subscribing organization to disclose subscriber-specific information will be referred to the point of contact designated on the Subscription Agreement.
The
Point of Contact on the subscriber agreement is no longer in the
organization. How can I change the Point of Contact?
A request to change a Point of Contact can be done by writing the MSSO helpdesk – email or fax is acceptable.
Email: mssohelp@ngc.com
Fax: 703.272.5635
When the MSSO receives a request to process a new point of contact, a new User ID and a new Change Request Identification Number (CR ID) will automatically be assigned to the subscribing organization and emailed to the new point of contact.
All subscriber-specific changes take effect immediately. Any requests to disclose the User ID, Password, or CR ID will then be referred to the new point of contact named in the request letter.
I had an Unzip password last version and now it doesn't work. Why not? How can I get a new one?
Unzip passwords are used to access MedDRA terminology internet file downloads for each language as well as SMQs that are in production. Unzip passwords change with each version of MedDRA. They are sent to the designated subscription point of contact approximately four weeks prior to the version release in order to give time to disseminate the information within the organization to those who need it. Please check with the designated subscription POC for this information. If you do not know who the POC is, please contact the MedDRA MSSO help desk at mssohelp@ngc.com.
In
what language is Help Desk Support available?
Help desk support is available in English. The Japanese Maintenance Organization has its own helpdesk for MedDRA-J subscribers. The MedDRA-J helpdesk is supported in Japanese. Their contact email is helpdesk.jmo@sjp.or.jp.
How do I access the MedDRA Forum?
To access the MedDRA Forum from the main MedDRA MSSO Web page, go to the MedDRA Forum link at the top of the page. You must log on using the User ID and Password assigned to you by the MSSO.
If you wish to post a new topic or provide comments to existing topics, you need to register to create your own unique User ID and Password of your chosing . Please note the ID/Password you create will be separate from the User ID/Password issued from the MSSO in relation to your subscription.
What is the MedDRA License Number that is required by EMEA for registration to EMEA Eudravigilance for electronic transmissions of ICSR?
The MedDRA License Number referred to by EMEA is the organization's User ID for its MedDRA subscription.
What are the eligibility requirements for the MedDRA EudraVigilance Fee Waiver License with EMEA?
The requirements for the MedDRA EudraVigilance Fee Waiver License are all of the following:
1) If your company meets the definition of a small (Turnover
≤ € 10 million or Balance sheet
≤ € 10 million) or micro (Turnover
≤ € 2 million or Balance sheet
≤ € 2 million) enterprise
2) Marketing Authorization Holder (MAH) must be located in the European Economic Area
As a MAH, if your organization meets all of the above requirements,
then you can use MedDRA for no charge within the EudraVigilance system.
You should complete your registration process with the EMEA. When you receive
access to EudraVigilance, you will receive access to MedDRA from the EMEA at the
same time. Their web site is: http://eudravigilance.emea.europa.eu/highres.htm.
What is the relationship between MedDRA and EudraVigilance?
MedDRA is the international medical terminology (Medical Dictionary for Regulatory Activities) developed under the auspices of ICH. As the terminology requires to be constantly updated, a Maintenance and Support Service Organisation (MSSO) was appointed under the umbrella of the ICH to maintain and distribute the terminology, on license, to users in industry and regulatory agencies. In Japan , the MedDRA maintenance is taken care of by the Japanese Maintenance Organization (JMO).
The activities of the MedDRA MSSO are overseen by the MedDRA Management Board composed of the six ICH parties, the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK , the Health Canada, The World Health Organization, and chaired by the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations).
In accordance with Community legislation and guidelines, MedDRA should be used by all stakeholders for the coding of medical information in the frame of the electronic transmission of individual case safety reports (ICSRs).
The EMEA provides interested organizations with reporting obligations in pharmacovigilance (pre- and post-authorisation phase) the possibility to use EVWEB, a web-based application, which is an integrated part of the European pharmacovigilance system called EudraVigilance. EVWEB incorporates MedDRA and allows for electronic reporting of ICSRs to the EMEA and National Competent Authorities in the EEA in compliance with the applicable ICH standards.
The MedDRA Management Board approved a MedDRA licence fee waiver programme to facilitate the electronic reporting by small and micro organizations and non-commercial sponsors of clinical trials. For details about the MedDRA licence fee waiver see https://eudravigilance.emea.europa.eu./human/meddra02.asp
EVWEB includes the use of MedDRA for reporting ICSRs and SUSARs into the EudraVigilance system. Access to MedDRA through the EVWEB is for online use and cannot be downloaded. EVWEB does not allow for off-line use of MedDRA for creating reports or analysis.
Who do I have to contact to get my MedDRA license?
The MSSO. To initiate a MedDRA Subscription, please visit the Subscribe to MedDRA section of the MedDRA MSSO Web site at http://www.meddramsso.com/MSSOWeb/subscriptions/index.htm. The site provides rates, subscription levels, applications, and information on how to subscribe to MedDRA.
If you require further information, please contact mssohelp@ngc.com .
What is my MedDRA license number?
The MedDRA MSSO assigns a number to each organization that applies for a MedDRA license.
An organization's MedDRA license number is a unique number you are given when you subscribe to MedDRA from the MSSO or the JMO. It is equivalent to the MedDRA User ID number associated with that organization's MedDRA subscription.
Organisations that qualify for the MedDRA license fee waver in the frame of EudraVigilance don't require a MedDRA license number.
How do I determine if I qualify for a MedDRA license fee waiver?
An organization may qualify for a MedDRA licence fee waiver if they are using EVWEB, the web application of EudraVigilance for electronic reporting of ICSRs.
Two types of organizations qualify for the EudraVigilance MedDRA licence fee waiver:
- Organizations (MAH or sponsors) that are Small and Micro Size Enterprises
- Sponsors of non-commercial Clinical Trials conducted in the EEA
Small and Micro Size Enterprises must be located in the EEA and have a turnover or balance sheet total that falls below the limits described in the table below.
Enterprise category |
Turnover* |
Or |
Balance sheet total* |
Small |
≤ 10 millions Euros |
≤ 10 millions Euros |
Micro |
≤ 2 millions Euros |
≤ 2 millions Euros |
*Turnover or Balance sheet total refers to the total revenue of the company, not just the pharmaceutical component.
A Sponsor of non-commercial clinical trials is defined, in the context of the MedDRA licensing policy as, as:
- A trial conducted by a non-commercial organization, with no industry sponsor, that is not part of the development program for a marketing authorization of a medicinal product; or
- If potentially leading to a marketing application, where the holder of the intellectual property/patent is a not-for profit organization.
A trial does not disqualify from being classified as non-commercial
- If the trial is funded in the form of an educational, unrestricted grant for administrative support, providing the funds do not exceed 10% of the cost of the trial, or
- Where drug is provided free by a company.
How do I apply for a MedDRA license fee waiver?
If your organization qualifies, you do not need to specifically
apply for a fee waiver. While registering with EudraVigilance, follow
the instructions. For more information see
https://eudravigilance.emea.europa.eu
/human/HowToRegister.asp
If you require further help, please contact the EMEA:
EudraVigilance Info Line +44 (0) 207 523 7077
EudraVigilance e-mail: eudravigilance@emea.eu.int
EudraVigilance web site: http://eudravigilance.emea.europa.eu
We are a CRO reporting to EudraVigilance on behalf of multiple
pharma companies; do both parties have to have a MedDRA license in order
to use the EVWEB?
The companies that you are representing need to be registered
with EudraVigilance. As part of the registration process they will
state that you are their third party service provider, and register
your details.
As part of the registration process every registering organization
will be asked to provide MedDRA subscription information:
- If the organization you are representing qualifies for the
EudraVigilance MedDRA license fee waiver they can precede to
finalise registration.
- If the organization you are representing does not qualify for
the EudraVigilance MedDRA license fee waiver they need to provide
their MedDRA license number, and then proceed to finalise
registration.
The organization for which you are acting as third party service
provider has to obtain a MedDRA license number and provide that number
during the registration process with EudraVigilance. Please note that
the MedDRA license number required in the registration form with
EudraVigilance is the registering organization's own, not the MedDRA's
licence number of any third party provider, such as a CRO.
Do I first need a MedDRA license fee waiver to qualify to use
the EVWEB system ?
If your organization qualifies for the MedDRA licence fee waiver
for EudraVigilance, you don't need a MedDRA subscription to use the
EVWEB.
If your organization does not qualify for the MedDRA licence fee
waiver, yes, you need to purchase a MedDRA subscription in order to
utilize the EVWEB system (see question 4).
Registering with EudraVigilance versus obtaining a
MedDRA license
All organizations with electronic reporting responsibilities
to the EMEA need to register with EudraVigilance
(see
https://eudravigilance.emea.europa.eu/human/HowToRegister.asp ).
During the registration procedure with EudraVigilance
you will be asked to declare you MedDRA license subscription
status:
- Organizations that do not qualify for the MedDRA
license fee waiver need to have a MedDRA license before
registering with EudraVigilance. For details
see http://www.meddramsso.com/MSSOWeb/evweb/waiver.htm.
The MedDRA license number needs to be provided during the
process of registration with EudraVigilance.
What is the versioning policy for reporting ICH ICSRs ?
With regard to the reporting of ICSRs to the EMEA, the
following MedDRA versions are accepted:
- EudraVigilance (production environment, EudraVigilance
post-authorisation module and Clinical Trial module)
accepts reports using the current version of MedDRA and the one
previous to it.
- EudraVigilance (test environment, EudraVigilance
post-authorisation module and Clinical Trial module)
accepts reports using version 4.0 and later versions.
- Retrospective reporting of ICSRs (‘Backlog reporting')
accepts version 4.0 or later versions.
Please note that MedDRA versions are updated every six months
(March and September).
The MSSO does recommend organizations to follow the Best Practices
document published on the MSSO Web site at
http://www.meddramsso.com/MSSOWeb/Docs/clinicaltrialversioning.pdf, which is endorsed by the MedDRA Management Board and provides options and recommendations for the implementation and versioning for clinical trials.
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