Ema Article57 MCP server

@pipeworx/ema-article57

EMA Article 57 product data — every medicine with a valid marketing authorisation anywhere in the European Economic Area (centrally, mutual-recognition, decentralised AND purely nationally authorised), one row per product x authorisation-country, with the marketing-authorisation holder and pharmacovigilance system location for each. Keyless.

Part of Pipeworx — an MCP gateway connecting AI agents to 1683+ live data sources.

This is EMA's WIDE register. The sibling ema-medicines pack covers only the EU centralised-procedure medicines (~1 row per medicine, richer fields — status, indications, approval dates). Article 57 is the opposite trade-off: thinner fields, but every EEA country's nationally authorised products too, which ema-medicines explicitly does not carry.

Tools

• emaarticle57search(query?, activesubstance?, holder?, country?, route?, limit?, offset?) — free-text/filtered search with real offset+limit pagination and a totalmatches count. Answers "which EEA countries is X authorised in", "who is the marketing-authorisation holder for X in country Y", "which products does company Z hold in the EEA".
• emaarticle57product(name, country?) — every authorisation-country record for one product by name (exact match preferred, falls back to substring with match_type marked). Article 57 carries no indication text and no per-product URL, so this returns the authoritative EMA source document URL instead of a paraphrased indication.
• emaarticle57recent_changes(since) — products added to / removed from the register since a date, computed by diffing this pack's own dated snapshots (the source has no change-date column at all — see Gotchas). Returns comparable: false with a stated reason rather than a guessed empty diff when no snapshot covers the requested window.
• emaarticle57dataset_info() — the authoritative EMA bulk-download URL, current row count, this pack's snapshot dates on record, and the full list of distinct authorisation-country values (for exact spelling before filtering by country).

Auth

Keyless.

Data sources

• — the Article 57 database export, linked from EMA's "Public data from Article 57 database" page. Verified live 2026-09-25: HTTP 200, Last-Modified: Thu, 24 Sep 2026 13:38:24 GMT, 7,870,020 bytes, 164,314 data rows. The page states the file carries "EMA/518502/2018 Rev. 88" and is updated "periodically" — there is no published cadence, so Last-Modified is the only real freshness signal.

Architecture — this pack does NOT fetch EMA live

Measured 2026-09-25 against the real file: 7.87 MB compressed unzips to 63.0 MB of sheet1.xml + 4.7 MB of sharedStrings.xml (164,314 rows x 8 columns). Parsing a much smaller EMA export with the same regex-scan approach (ema-medicines's ~0.9 MB report) already measured 123 MB of V8 heap; this file is ~9x bigger and would not fit in a Cloudflare Worker's 128 MB ceiling. So this pack reads a pre-built, pre-compacted dataset from the shared pipeworx-datasets R2 bucket instead of calling EMA per request. scripts/ingest-ema-article57.mjs does the actual fetch + XLSX parse (offline, not in a Worker) and writes:

• ema-article57/latest.json.gz — all 164,314 rows, dictionary-encoded (schema 2: each column is a table of unique strings plus one integer index per row), 6.35 MB raw / 1.42 MB gzipped, read once per isolate.

Shortened. The full README is on GitHub.