INOPP Forum

Please or Register to create posts and topics.

All about MedDRA

Subscription Types

The MSSO provides different types of subscriptions based on the type of the organisation. MSSO subscriptions are for twelve months. During the renewal process, the current subscription type and level (if applicable) is reviewed to see if the subscription type is still accurate.

There are four different types of MedDRA MSSO subscriptions:

  • Regulatory Authority all regulatory authorities are eligible to receive MedDRA at no charge. This includes the English version of each release of MedDRA as well as all available translations.

  • Non-Profit / Non-Commercial are reserved for non-profit medical libraries, educational institutions, and direct patient care providers, i.e., hospitals for educational use or as a reference tool. In general, any non-commercial organisation conducting non-commercial work.

  • Commercial – are for commercial organisations (e.g., pharmaceutical companies, CROs). The rates vary based on the annual revenue (turnover) of the organisation.

  • System Developer are reserved for organisations that develop software products that utilise MedDRA. The use of MedDRA by system developers is limited to software development and testing with MedDRA and not for providing MedDRA support services (e.g., coding, analysis, transmission of MedDRA coded data).

Here's how to subscribe to MedDRA:

1. If your organisation is headquartered in Japan, please contact the Japanese Maintenance Organization at https://www.pmrj.jp/jmo/php/indexe.php , otherwise continue to Step 2.

2. Determine the type of subscription applicable to your organisation.

3. Determine the rate that is applicable to the subscription type.

4. Complete the online subscription form.

5. If you are requesting a commercial subscription, please upload an annual report or a signed statement from your organisation on letterhead describing total revenue or turnover for its most recently completed fiscal year.

6. Your subscription includes English and all translations.

7. Submit your online subscription form.

8. You may save or print a copy of the completed subscription form after submission.

9. The MSSO will email an invoice to the designated billing point of contact for payment if applicable. Upon receipt of payment, the MSSO will provide the information to download MedDRA.

TRAINING MATERIALS

Points to Consider Document

 

 

 

In what language is MedDRA available?

MedDRA is available in Chinese, Czech, Dutch, English, French, German, Hungarian, Italian, Japanese, Korean, Portuguese, Portuguese - Brazilian, Russian, and Spanish to all users via download.

Should both - Service provider and Client have MedDRA Subscription?

It is the intent of the ICH, the owners of MedDRA, that all pharmaceutical companies have a current MedDRA licence to code, analyse, report, or hold MedDRA coded data. CROs that code, report, or hold MedDRA coded data must also have a current licence to MedDRA. Otherwise, the sharing of data violates the MedDRA licencing agreement created by the ICH regarding the distribution of MedDRA to another party. You may also see our Statement on MedDRA Data Sharing. Click on How to Share MedDRA Data on the kiosk of the Subscription Process page.