Short Description

There are a number of medication definition resources, all at a low maturity, and they need additional validation.  This track is to start that process. 

Long Description

There are a number of Medication Definition resources which need to be validated by use in practical scenarios.  The EMA intend to use these resources for registration of medicinal products through IDMP,  FDA are using them for assessment of product manufacturing quality and Health Canada are using them for authorizing and licensing of production facilities.  These three use cases are managed through a single track that reflects the early lifecycle of a medicinal product.

Background Reading


and there is a DevDays presentation here: YouTube Video


Thursday January 14th
8:00-19:00 Pacific Time (UTC-8) (11:00-22:00 ET 16:00-03:00 GMT)

Track Kickoff
8:30-9:30 Pacific Time (UTC-8) (11:30-12:30 ET 16:30-17:30 GMT)

This is an introduction and informal meet and great session. Brief overview of the track and the server that is available. Attendees can say what they want to achieve, what experience and/or software or data that they bring (if any), and so on. Individuals and groups can connect with each other, and decide what to work on together.
This is not intended to be a tutorial, but track leads will be able to give pointers and generally advise, as they will throughout the event.

Followed by the main business - an ad-hoc working session during the day. Attendees work on their own projects, and/or collaborate, create and exchange data etc., report achievements, queries, blockers, requests etc via Zulip chat stream. 

Please raise issues (or just general chat) on the Zulip stream #Vulcan/MedicationDefinition>Connectathon 2021-01
We will have unscheduled Zoom breakouts where necessary, and otherwise keep in touch via Zulip chat.
Breaks etc are up to individuals, and people are of course free to continue working outside of the published hours.
Track leads will be available most of the time, if not continuously, except perhaps towards the end of Day 1 (due to timezone challenges).

Friday January 15th 
8:00-16:00 Pacific Time (UTC-8) (11:00-19:00 ET 16:00-00:00 GMT)

Day 2 kickoff 
8:30-9:00 Pacific Time (UTC-8) (11:30-12:00 ET 16:30-17:00 GMT)

Informal greet and chat session for day 2. Reports from day 1, issues, collaborations, new joiners etc.

Followed by ad-hoc working session during the day - please raise issues on the Zulip stream #Vulcan/MedicationDefinition>Connectathon 2021-01
Share, collate and record progress as we go.

Lessons Learned? & What next? Report Out Slides
1pm - 2pm Pacific Time (UTC-8) (4pm-5pm ET 21:00-22:00 GMT)

A session to summarise to ourselves what have we achieved and what are the next steps to take in the development of these resources, including in a future session (e.g. May 2021). 

Create and review the report out slide, to record for the wider Connectathon what was achieved. (There are usually too many groups for these slides to be presented to the entire Connectathon). Also general achievements can be reported to the group as we go, via chat.

Followed by some final working, then followed by:

General Joint Wrap Up Session (all groups)

4:00-4:30 Pacific Time (UTC-8)

Event close, followed by Virtual Happy Hour - 4:30-5:30 Pacific Time (UTC-8)


Test the design of a set of resources

Submitting Work Group/Project/Accelerator/Affiliate/Implementer Group  

Vulcan / BR&R

Proposed Track Lead

Related Tracks

FHIR Version

FHIR R4B or R5 ( A server will be provided for R5 Preview 2 version, see below. Advice on the different versions will be available.

Specification(s) this track uses


A FHIR server is accessible at Please contact track leads for access. The server requires a login.  A number of free accounts have been created and will be issued to participants. Please ask for one if you need it. 

The server supports FHIR v4.4.0 (R5 preview 2). Link to FHIR documentation for this specific version:

Artifacts of focus

The resources listed under Medication Definition

Clinical input requested (if any)


Patient input requested (if any)


Expected participants

EMA, Heath Canada, FDA, Vulcan members, Unicom project members, and any other interested parties

Zulip stream

#Vulcan/MedicationDefinition>Connectathon 2021-01


Track Orientation Details

The recording of the session is here: Vulcan Medication Definition Orientation 2020-12-17.mp4

Track Details


The intent of the Connectathon track is twofold:

To enable the FHIR community to familiarize themselves with the Medication Definition resources and to get advice from the participants on the usage, direction, and any other resource related question they may have.

Additionally, to enable the participants to ensure that the approach and models being used to represent the resources meets the business objectives.

The description of detailed product or product related information, including the products themselves, packages, the actual drug items (e.g., tablets), and ingredients, as well as aspects related to regulation of products.

To assist the server will be populated with examples that can freely be used as starting points.

Log the data items that have been used here (should not need a login):


The participants are encouraged to work with the resources in any way they would like, some potential ideas have been listed below as inspiration.

  • Create a product and associate package definitions to the product
  • Create a Substance Definition
  • Create a links between product(s), ingredient(s) and substance(s)
  • Update an existing product to increase the scope or details, such as adding additional package types
  • Create regulated authorizations

Connectathon Scenario

To further/mature the Medication Definition resources scenarios that fully or partially represent medicinal products should be tested during the Connectathon. The intent is gain general experience with the resources thereby identifying issues and concerns.

This would be done by creating /updating one or more of the following resources, any of the following can be used and the step number does not represent an order it is solely included to assist with references, as in some cases the attributes point to existing resources and some aspects of the resources build upon other resources.

  1. MedicinalProductDefinition
    1. Optionally browse the server for existing product data
    2. Create your own product, using provided example data, or your own, to populate as much content as possible.
      Examples: product names, dose form, classifications, characteristics, legal status, manufacturers, relationships to other products and so on. Note that some data can be described using other linked resources, as below.
    3. Track leads and other participants can advise on mappings
    4. Resources can be reviewed by others, in XML format (or JSON)
    5. Resources can be uploaded to the server(s) where they can be viewed, downloaded and reviewed by others
    6. Repeat for other products
    7. Extend the product definition using other linked resources, as below
  2. PackagedProductDefinition
    1. Add a package description to a product from step 1
    2. Use provided data, or your own to populate as much data as possible
      g., just the basics – the name of a package (e.g., “WonderDrug 20mg 50 tablet pack”), or the full package configuration (using PackagedProductDefinition.package) to show pack contents, materials etc.
    3. Usually the package references (“links to”) the MedicinalProductDefinition using PackagedProductDefinition.subject
    4. Upload this to the server, review.
    5. Repeat for another package type for the same product, or a different one.
  3. ManufacturedItemDefinition
    1. Add a manufactured packaged item (e.g., a tablet, liquid, or co-packaged device) to the package from step 2. Upload, review, repeat etc
  4. Ingredient
    1. Add an ingredient to a manufactured item from step 3 (via PackagedProductDefinition.package.containedItem) , or directly to a product (from step 1) using MedicinalProductDefinition.ingredient
  5. SubstanceDefinition
    1. Add a substance definition and optionally link to the Ingredient from step 4
  6. AdministrableProductDefinition
    1. Add a resource describing the “ready to administer” form of the product and link it to the product from step 1 via administrableProduct.product (or by using AdministrableProductDefinition.subject)
  7. RegulatedAuthorization 
    1. Add the record of a regulated authorization and link it to the relevant product or substance definition from step 1 or 5 respectively using RegulatedAuthorization.subject.
    2. Establish observations on a facility resource and then adding a RegulatedAuthorization to describe them. This represents a simulated site inspection and the results.
    3. Try applying for licences relating to controlled substances, regulated parties, or regulated activities.
  8. ClinicalUseIssue
    1. Add information related to an indication or contraindication for the product.
  9. DeviceDefinition
    1. Add information related to a device accompanying the administrable product and assign it to the packaged product as well as a contained item.


Due to the information access model on this Proof of Concept environment it is critical that everyone uses artificial information (i.e. no real people, products, organizations, etc. should be included in the information provided or used).

Security and Privacy Considerations:

The server requires a login.  A number of free accounts have been created and will be issued to participants. Please ask for one if you need it.