Skip to main content
PolicySpeak
← All legislative files
Regulation (EU) 2019/9332018/0161(COD)COM(2018)317

Supplementary protection certificate for medicinal products

Optimising the Internal Market's industrial property legal framework re. SPC and patent research

Stage
In force, reached 11 Jun 2019
In force
In force since 1 Jul 2019 · CELEX 32019R0933
Procedure
Ordinary legislative procedure
Lead DG
DG GROW
Commissioner
Elżbieta Bieńkowska
Last activity
1 Jul 2019
18 entries · record as of 30 Sept 2026

Where it stands

Latest: Publication in the Official Journal, 11 Jun 2019.

Show the earlier record: 10 dates, 28 May 2018 to 11 Feb 2019
  1. 28 May 2018
    • Adoption by Commission
  2. 29 May 2018
    • Discussions within the Council or its preparatory bodies
  3. 15 Jun 2018
    • Discussions within the Council or its preparatory bodies
  4. 2 Jul 2018
    • Referral of the legislative proposal to the EP committee responsible (announced in plenary)
  5. 3 Jul 2018
    • Discussions within the Council or its preparatory bodies
  6. 8 Aug 2018
    • Feedback on adopted proposal closed: Optimising the Internal Market's industrial property legal framework re. SPC and patent research · Commission
  7. 1 Oct 2018
    • Discussions within the Council or its preparatory bodies
  8. 26 Nov 2018
    • Discussions within the Council or its preparatory bodies
  9. 16 Jan 2019
    • Discussions within the Council or its preparatory bodies
  10. 11 Feb 2019
    • Endorsement by EP plenary of the committee decision to start interinstitutional negotiations
  1. 20 Feb 2019
    • Discussions within the Council or its preparatory bodies
  2. 17 Apr 2019
    • EP position at first reading
  3. 30 Apr 2019
    • Discussions within the Council or its preparatory bodies
  4. 6 May 2019
    • Discussions within the Council or its preparatory bodies
  5. 7 May 2019
    • Discussions within the Council or its preparatory bodies
  6. 14 May 2019
    • Approval of the EP's first reading position by the Council (adoption of the legislative act)
  7. 20 May 2019
    • Signature by the president of the EP and by the president of the Council
  8. 11 Jun 2019
    • Publication in the Official Journal
31 amendments

Amendments

Tabled on 12 Apr 2019. The texts are in the amendment documents below.

By committee

  • JURI31

By article

  • Annex2
  • Article 1 – paragraph 1 – point -1 (new)1
  • Article 1 – paragraph 1 – point 11
  • Article 1 – paragraph 1 – point 1 a (new)1
  • Article 1 – paragraph 1 – point 21
  • Article 1 – paragraph 1 – point 31
  • Article 1 – paragraph 1 – point 41
  • Recital 101
  • Recital 111
  • Recital 121
Show 20 more provisions
  • Recital 131
  • Recital 13 a (new)1
  • Recital 141
  • Recital 171
  • Recital 191
  • Recital 19 a (new)1
  • Recital 21
  • Recital 2 a (new)1
  • Recital 201
  • Recital 211
  • Recital 221
  • Recital 31
  • Recital 3 a (new)1
  • Recital 3 b (new)1
  • Recital 41
  • Recital 51
  • Recital 61
  • Recital 71
  • Recital 81
  • Recital 91
11 documents

Documents

Newest first. Each opens at its source.

1 consultation

Consultations on it

The Commission's Have Your Say consultations linked to this file. Each title opens on the Commission's portal.

ConsultationFeedback deadline
8 Aug 2018

Summary

Generated

This in-force regulation streamlines the supplementary protection certificate (SPC) system and improves patent research transparency to reduce legal uncertainty and costs for innovative industries. It primarily affects pharmaceutical, agrochemical, and biotech sectors, as well as generic manufacturers. The framework aims to create a more predictable EU-wide intellectual property environment.

What the workspace adds on this file

Everything above is the public record. In the workspace, subscribers see this file 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: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 30 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.

Hosted in the EU · Security →

By submitting, you agree to our privacy policy.