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MedDRA Subscriptions FAQI 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 organizations may be interested in subscribing to MedDRA:
What types of subscriptions are available?
Four types of MedDRA subscriptions are available from the MSSO: Regulatory Authorities, Basic Service, Core Services, and System Developer.
What is a 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:
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 to code, analyze, report, or hold MedDRA coded data. CROs that 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 comes with a core services subscription of MedDRA?
A core subscription is available as a renewable yearly subscription. With a core subscription, MSSO provides:
Change Requests are included with the Core subscription. There are additional purchasable services available through the MSSO.
What is a system developer subscription?
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. MedDRA cannot be embedded into their developed products. With a system developer subscription, MSSO will provide:
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 determining 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 provides year-round coverage help desk support in English for subscribers. The help desk will answer questions regarding MedDRA MSSO products and services 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 organization classification and 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 MedDRA subscription rates are reviewed and established by the MedDRA Management Board on an annual basis.
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, 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. 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 are subscription renewals 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?
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 are capped at a Core 1 rate.
What is the release schedule for MedDRA?
MedDRA is released on 1 March and 1 September.
In what language is the terminology available?
The terminology is available in Chinese, Czech, Dutch, English, French, German, Italian, Japanese, Portuguese, and Spanish to all subscribers via download. Chinese and Japanese translations of MedDRA are available for an additional fee.
Where do I download translations of MedDRA?
Subscribers may download translations of MedDRA on the Download section of the web site in the MedDRA Terminology area.
What are the maintenance rights for a core subscriber?
The maintenance rights available to a core services subscriber are as follows:
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. 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 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: 1.703.272.5635 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.
How do I change a subscription Point of Contact?
To change the point of contact, send an email or fax to the MSSO Help Desk. Email: mssohelp@ngc.com Fax: +1 703.272.5635 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 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 and Chinese. The Japanese Maintenance Organization has its own Help Desk for MedDRA/J subscribers. The MedDRA/J Help Desk is supported in Japanese. Their contact email is helpdesk.jmo@sjp.or.jp.
What is the MedDRA License Number that is required by EMA for registration to EMA EudraVigilance for electronic transmissions of ICSRs?
The MedDRA License Number referred to by EMA is the organization's User ID for its MedDRA subscription.
What is the relationship between MedDRA and EudraVigilance?
MedDRA is the international medical terminology (Medical Dictionary for Regulatory Activities) developed under the auspices of the 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, Health Canada, The World Health Organization, and chaired by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). 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 EMA 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 EMA and National Competent Authorities in the EEA in compliance with the applicable ICH standards. The MedDRA Management Board approved a MedDRA license fee waiver program to facilitate the electronic reporting by small and micro organizations and non-commercial sponsors of clinical trials. For details about the MedDRA license fee waiver see the EudraVigilance web page for MedDRA Licensing Policy. 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.
How do I determine if I qualify for a MedDRA EudraVigilance license fee waiver with the EMA?
See the Special License tab on the MedDRA Subscription Types page.
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 the EudraVigilance web site for How to Register. If you require further help, please contact the EMA: EudraVigilance Info Line +44 (0) 207 523 7077
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:
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 license 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 license fee waiver for EudraVigilance, you don't need a MedDRA subscription to use the EVWEB. If your organization does not qualify for the MedDRA license fee waiver, yes, you need to purchase a MedDRA subscription in order to utilize the EVWEB system.
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