# Supplementary protection certificate for medicinal products

European Parliament procedure 2018/0161(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 8th term, committee ENVI / INTA / JURI). Stage: Procedure completed. 556 committee amendments tabled by 55 Members between 2018-10-17 and 2018-11-28.

## What the amendments focus on

Proposal on the supplementary protection certificate for medicinal products. The amendments revise recitals on a manufacturing exception for generics and biosimilars, allowing making for export to third countries and for day-1 entry to the Union market after the certificate expires, while debating intellectual property and patent rights, affordability of medicines, and safeguards such as notification duties and due-diligence requirements on the maker and its supply chain.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Kosma ZŁOTOWSKI | Poland | ECR | 42 | https://amendeu.com/md/meps/124884.md |
| Alojz PETERLE | Slovenia | PPE | 42 | https://amendeu.com/md/meps/23693.md |
| Christofer FJELLNER | Sweden | PPE | 34 | https://amendeu.com/md/meps/28126.md |
| Tadeusz ZWIEFKA | Poland | PPE | 34 | https://amendeu.com/md/meps/28301.md |
| Soledad CABEZÓN RUIZ | Spain | S&D | 30 | https://amendeu.com/md/meps/125041.md |
| Elisabetta GARDINI | Italy | PPE | 27 | https://amendeu.com/md/meps/58758.md |
| Aldo PATRICIELLO | Italy | PfE | 27 | https://amendeu.com/md/meps/36392.md |
| Andrzej GRZYB | Poland | PPE | 27 | https://amendeu.com/md/meps/23785.md |
| Tiemo WÖLKEN | Germany | S&D | 27 | https://amendeu.com/md/meps/185619.md |
| José Inácio FARIA | Portugal | PPE | 26 | https://amendeu.com/md/meps/125101.md |
| Jean-Marie CAVADA | France | ALDE | 26 | https://amendeu.com/md/meps/28206.md |
| António MARINHO E PINTO | Portugal | ALDE | 26 | https://amendeu.com/md/meps/124742.md |
| Enrico GASBARRA | Italy | S&D | 25 | https://amendeu.com/md/meps/124817.md |
| Sergio Gaetano COFFERATI | Italy | S&D | 24 | https://amendeu.com/md/meps/96915.md |
| Stefano MAULLU | Italy | PPE | 24 | https://amendeu.com/md/meps/133326.md |

## Official source documents

- PE629.448: http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf
- PE630.399: http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf
- PE630.706: http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2018-0161-COD · machine-readable: https://amendeu.com/data/dossiers/2018-0161-COD.json

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Source: AmendEU (amendeu.com), built from Parltrack (ODbL), European Parliament Open Data ((c) European Union) and official Parliament documents. Aggregates CC BY 4.0.
Data refreshed: 2026-07-27. Human-readable version: https://amendeu.com/dossiers/2018-0161-COD
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