Orphan Medicinal Products Regulation

Proposal for a EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) on orphan medicinal products

Stage: In force
In force: In force since 22 Jan 2000 · CELEX 32000R0141
Procedure: Regulation
Last activity: 16 Dec 1999

1 act

Delegated and implementing acts beneath it

By status: 1 published.

Act	Kind	Status	Adoption
Commission Delegated Regulation (EU) 2013/877	Implementing · Regulation	Published

Titles link to EUR-Lex where the act has been published.

Summary

Generated

Regulation (EC) No 141/2000 sets a Community procedure for designating orphan medicinal products and provides incentives, including 10-year market exclusivity (reducible to six years). It applies to sponsors seeking designation for conditions affecting not more than five in 10,000 persons. The regulation is in force; the current consolidated version dates from 26 July 2019.

What the workspace adds on this file

Everything above is the public record. Subscribers see this page with their own layer on top.

Why it matters to you

What this file means for your organization, assessed against your own priorities.

What moved

When this file moves, it reaches your own briefing, with a link to its source.

Your contacts on it

Your team's contacts logged against this file: who you met, what was said and the next step.

A first draft

A statement, a member update or a meeting brief on this file, in your organization's voice, with its sources.

Sources: EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

Request access

See this file with your own layer on top: why it matters to you, your contacts on it and a first draft. We’ll schedule a 20-minute walkthrough.

EU-hosted · GDPR-compliant · Trust Center →

By submitting, you agree to our privacy policy.