1998/0240(COD)

Orphan Medicinal Products Regulation

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

Stage: In force, reached 22 Jan 2000
In force: In force since 22 Jan 2000 · CELEX 32000R0141
Procedure: Regulation · Ordinary legislative procedure
Last activity: 22 Jan 2000

1 act

Delegated and implementing acts beneath it

By status: 1 published.

Act	Kind	Status	Adoption
Commission Implementing Regulation (EU) 2018/781	Implementing · Regulation	Published

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

12 documents

Documents

Newest first. Each opens at its source.

Report · A4-0078/1999Parliament
Report · A5-0080/1999Parliament
OJ C 101 12.04.1999, p. 0037Commission
OJ C 175 21.06.1999, p. 0004Commission
OJ C 194 11.07.2000, p. 0006Commission
OJ C 276 04.09.1998, p. 0007Commission
OJ C 296 18.10.2000, p. 0035-0091Commission
OJ C 317 04.11.1999, p. 0034Commission
Text adopted · OJ L 018 22.01.2000, p. 0001Commission
Text adopted · Regulation 2000/0141Commission
SEC(2006)0832Commission
Text adopted · T5-0148/1999Parliament

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.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 30 Sept 2026. Something wrong on this page? Report an error.

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