Source: EURLEX
Language: en
Format: md

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

**Interinstitutional File:**

**2023/0132(COD)**

**COVER NOTE**

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

**8759/23**
**ADD 7**

**SAN 217**
**PHARM 63**
**MI 340**
**COMPET 372**
**ENV 428**
**PI 51**
**CODEC 726**
**IA 84**

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

date of receipt: 26 April 2023

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

No. Cion doc.: SWD(2023) 193 final

Subject: COMMISSION STAFF WORKING DOCUMENT EXECUTIVE
SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying
the documents Proposal for a Directive of the European Parliament and
of the Council on the Union code relating to medicinal products for
human use, and repealing Directive 2001/83/EC and Directive
2009/35/EC Proposal for a Regulation of the European Parliament and
of the Council laying down Union procedures for the authorisation and
supervision of medicinal products for human use and establishing rules
governing the European Medicines Agency, amending Regulation (EC)
No 1394/2007 and Regulation (EU) No 536/2014 and repealing
Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and
Regulation (EC) No 1901/2006

Delegations will find attached document SWD(2023) 193 final part 2/2.

Encl.: SWD(2023) 193 final

8759/23 ADD 7 KDB/ng
## LIFE 5 EN

EUROPEAN

COMMISSION

Brussels, 26.4.2023
SWD(2023) 193 final

PART 2/2

**COMMISSION STAFF WORKING DOCUMENT**

**EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT**

_**Accompanying the documents**_

**Proposal for a Directive of the European Parliament and of the Council on the Union**
**code relating to medicinal products for human use, and repealing Directive 2001/83/EC**

**and Directive 2009/35/EC**

**Proposal for a Regulation of the European Parliament and of the Council laying down**

**Union procedures for the authorisation and supervision of medicinal products for**
**human use and establishing rules governing the European Medicines Agency, amending**

**Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing**
**Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No**

**1901/2006**

{COM(2023) 192 final} - {COM(2023) 193 final} - {SEC(2023) 390 final} 
{SWD(2023) 191 final} - {SWD(2023) 192 final}

# **EN EN**