The PDC (Product Detail Country) segment describes a product as it is marketed in a specific country. It carries the manufacturer or distributor, the country of marketing authorisation, the brand and generic names, model and catalogue identifiers, and shelf-life dates — the regulatory fingerprint of the product implicated in a post-market surveillance report.
Purpose
PDC tells the receiving regulator exactly which national variant of a product was involved in an adverse experience. The same medicine or device is often marketed under different brand names, package configurations, or marketing-authorisation IDs in different countries; PDC pins those facts down so that the report can be matched to the correct registration dossier.
Used in
PDC appears in product-experience / post-market surveillance PEX messages reporting adverse drug or device events to regulators such as the FDA, EMA, or MHRA. A PEX transaction may include several PDC segments when the same product is registered in multiple jurisdictions or when several products are implicated.
Field-by-field
Each row below reflects the HAPI HL7 v2.5.1 javadoc for PDC. Required fields are marked R; everything else is optional. Repeating fields are flagged Y. Data type names link to their reference page; lengths are not standardised at the segment level for v2.5.1 and are shown as "—".
| Seq | Name | Data Type | Length | Req | Repeat | Table # | Description |
|---|---|---|---|---|---|---|---|
| PDC-1 | Manufacturer/Distributor | xon | — | R | Y | — | Organisation marketing the product |
| PDC-2 | Country | ce | — | R | — | — | Country of marketing authorisation |
| PDC-3 | Brand Name | st | — | R | — | — | Brand name as marketed in country |
| PDC-4 | Device Family Name | st | — | O | — | — | Family or product line name |
| PDC-5 | Generic Name | ce | — | O | — | — | Coded generic or non-proprietary name |
| PDC-6 | Model Identifier | st | — | O | Y | — | Manufacturer model identifier |
| PDC-7 | Catalogue Identifier | st | — | O | — | — | Catalogue or part number |
| PDC-8 | Other Identifier | st | — | O | Y | — | Additional product identifiers |
| PDC-9 | Product Code | ce | — | O | — | — | Regulatory product classification code |
| PDC-10 | Marketing Basis | id | — | O | — | HL70330 | Regulatory basis for marketing |
| PDC-11 | Marketing Approval ID | st | — | O | — | — | Marketing authorisation identifier |
| PDC-12 | Labeled Shelf Life | cq | — | O | — | — | Shelf life as printed on the label |
| PDC-13 | Expected Shelf Life | cq | — | O | — | — | Manufacturer's expected shelf life |
| PDC-14 | Date First Marketed | ts | — | O | — | — | Date product first sold in country |
| PDC-15 | Date Last Marketed | ts | — | O | — | — | Date product withdrawn from market |
Examples
Minimal
A PDC with only the three required fields — manufacturer, country, and brand name.
PDC|Helios Pharmaceuticals^^L|US^United States^ISO3166|Cardiozen
Fully populated
PDC|Helios Pharmaceuticals^^L|US^United States^ISO3166|Cardiozen|Cardiozen XR|N02BE01^Metoprolol^ATC|CZ-50-XR~CZ-100-XR|CAT-50441|NDC-71744-0050-1|N|NDA-214412|24^months^UCUM|36^months^UCUM|20180915000000|
Annotated breakdown
PDC
|Helios Pharmaceuticals^^L PDC-1 Manufacturer (required)
|US^United States^ISO3166 PDC-2 Country (required)
|Cardiozen PDC-3 Brand name (required)
|Cardiozen XR PDC-4 Device/product family
|N02BE01^Metoprolol^ATC PDC-5 Generic name (coded)
|CZ-50-XR~CZ-100-XR PDC-6 Model identifier (repeats)
|CAT-50441 PDC-7 Catalogue identifier
|NDC-71744-0050-1 PDC-8 Other identifier
|N PDC-9 Product code (regulatory)
|N PDC-10 Marketing basis (NDA)
|NDA-214412 PDC-11 Marketing approval ID
|24^months^UCUM PDC-12 Labeled shelf life
|36^months^UCUM PDC-13 Expected shelf life
|20180915000000 PDC-14 Date first marketed
| PDC-15 Date last marketed (still on market)
In context — PEX message excerpt 1
A PEX report identifying a US-marketed cardiac drug implicated in a hypotensive episode.
MSH|^~&|MEDWATCH|CLINIC-OH|FDA-AERS|FDA|20260601120000||PEX^P07^PEX_P07|MSG00012741|P|2.5.1
EVN|P07|20260601120000
PID|1||PT-44871^^^CLINIC-OH^MR||Okafor^Adaeze^M||19620318|F
PES|Riverford Cardiology^^L|Adekoya^Tomi^J^^Dr.|140 Clinic Way^^Riverford^OH^45402^USA|^WPN^PH^^^937^5550199|SE-2026-7741|1|||20260601090500|20260601120000|I|P|R
PEO|AE-2026-7741^Severe Hypotension^L|R55^Syncope^I10|20260601084500
PCR|N02BE01^Metoprolol^ATC|P|||20260601083000
PDC|Helios Pharmaceuticals^^L|US^United States^ISO3166|Cardiozen|Cardiozen XR|N02BE01^Metoprolol^ATC|CZ-50-XR|CAT-50441|NDC-71744-0050-1||N|NDA-214412|24^months^UCUM|36^months^UCUM|20180915000000
In context — PEX message excerpt 2
A PEX report covering an infusion pump device involved in an over-delivery event in Canada.
MSH|^~&|SAFETY|VENDOR-MFR|HC-CV|HEALTH-CANADA|20260418161500||PEX^P07^PEX_P07|MSG00012088|P|2.5.1
EVN|P07|20260418161500
PID|1||PT-77321^^^HOSP-ON^MR||Singh^Rohan^||19770212|M
PES|MediFlow Devices Canada^^L|Nguyen^Phuc^^^Ms.|22 Bayfront Rd^^Toronto^ON^M5J2N8^CAN|^WPN^PH^^^416^5550188|SE-2026-9088|1|Pump over-delivered 18 mL bolus||20260415130000|20260418160000|I|N|R
PEO|AE-2026-9088^Drug Over-Delivery^L|T88.7^Adverse effect of drug^I10|20260415132000
PCR|DEV-INF-PUMP^Infusion pump^L|D|||20260415130000
PDC|MediFlow Devices Inc^^L|CA^Canada^ISO3166|FlowMaster|FlowMaster 4000|DEV-INF-PUMP^Infusion pump^L|FM4000-V3~FM4000-V3A|CAT-FM-4000|LIC-104412|D|D|MDL-104412|36^months^UCUM|60^months^UCUM|20191101000000
Implementation notes
- PDC-1, PDC-2, and PDC-3 (manufacturer, country, brand name) are required by the standard. Without all three a regulator cannot reliably identify which national registration the report concerns.
- PDC-6 (Model Identifier) and PDC-8 (Other Identifier) repeat to allow several model or part numbers when the same incident spans configurations.
- For drug products, PDC-10 typically carries the marketing basis (e.g. NDA) and PDC-11 the approval number; for device products, the equivalent licence or 510(k) number is placed in PDC-11.
- Leave PDC-15 (Date Last Marketed) empty while the product is still on the market; populate it only after withdrawal.
Related segments
- PEO — describes the clinical observation tied to this product.
- PES — identifies the sender filing the report.
- PEX message — the trigger event that carries PDC end-to-end.
