Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional Files:**

**2023/0128(COD)**
**2023/0126(COD)**
**2023/0127(COD)**
**2023/0130(COD)**

**COVER NOTE**

**Brussels, 28 April 2023**
**(OR. en)**

**8887/23**
**ADD 5**

**PI 55**
**PHARM 67**
**COMPET 383**
**MI 351**
**IND 204**
**IA 88**
**CODEC 746**

From: Secretary-General of the European Commission, signed by Ms Martine
DEPREZ, Director

date of receipt: 27 April 2023

To: Ms Thérèse BLANCHET, Secretary-General of the Council of the
European Union

No. Cion doc.: SWD(2023) 119 final

Subject: COMMISSION STAFF WORKING DOCUMENT EXECUTIVE
SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying
the documents Proposal for a Regulation of the European Parliament
and of the Council on the supplementary protection certificate for
medicinal products (recast) and Proposal for a Regulation of the
European Parliament and of the Council on the supplementary
protection certificate for plant protection products (recast) and Proposal
for a Regulation of the European Parliament and of the Council on the
unitary supplementary protection certificate for medicinal products, and
amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006
as well as Regulation (EU) No 608/2013 and Proposal for a Regulation
of the European Parliament and of the Council on the unitary
supplementary protection certificate for plant protection products

Delegations will find attached document SWD(2023) 119 final.

Encl.: SWD(2023) 119 final

8887/23 ADD 5 BM/ps
## COMPET.1 EN

EUROPEAN

COMMISSION

Brussels, 27.4.2023
SWD(2023) 119 final

**COMMISSION STAFF WORKING DOCUMENT**

**EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT**

_**Accompanying the documents**_

**Proposal for a Regulation of the European Parliament and of the Council on the**

**supplementary protection certificate for medicinal products (recast)**

**and**

**Proposal for a Regulation of the European Parliament and of the Council on the**

**supplementary protection certificate for plant protection products (recast)**

**and**

**Proposal for a Regulation of the European Parliament and of the Council on the unitary**

**supplementary protection certificate for medicinal products, and amending Regulation**
**(EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013**

**and**

**Proposal for a Regulation of the European Parliament and of the Council on the unitary**

**supplementary protection certificate for plant protection products**

{COM(2023) 221 final} - {SEC(2023) 172 final} - {SWD(2023) 117 final} 
{SWD(2023) 118 final}

# **EN EN**

1 [Council conclusions on IP policy of 10 November 2020 https://www.consilium.europa.eu/media/46671/st](https://www.consilium.europa.eu/media/46671/st-12750-2020-init.pdf)
[12750-2020-init.pdf](https://www.consilium.europa.eu/media/46671/st-12750-2020-init.pdf)
2 European Parliament, Committee on Legal Affairs, Report on an intellectual property action plan to support
[the EU’s recovery and resilience (2021/2007(INI)), https://www.europarl.europa.eu/doceo/document/A-9-](https://www.europarl.europa.eu/doceo/document/A-9-2021-0284_EN.html)
[2021-0284_EN.html](https://www.europarl.europa.eu/doceo/document/A-9-2021-0284_EN.html)

1

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|Col1|€ per applicant|Savings compared to the<br>baseline|
|---|---|---|
|Filing fees|38,800|-30,000|
|Maintenance fees for 5 years|71,900|111,100|
|Translation costs|0|4,000|
|Agent/attorney’s fees|2,000|52,000|
|Total|112,700|137,100|

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