Thu 29 Oct 2026 00:49:50 BST

Search Company

OMS Organisation Identifier:

OMS Location Identifier:

NCA Reference Key:

Address:

Country:

Active Substance

New Active Substance

Search Site

Create Site

Update Site

Current data stored in EudraGMDP database

Current data stored in OMS

DUNS Number:

NCA Reference Key:

Site Name:

OMS Organisation Identifier:

OMS Location Identifier:

Address Line 1:

Address Line 2:

Address Line 3:

Address Line 4:

City:

County:

Postcode:

Country:

Additional Details on Units Inspected

Site under Compliance Management:

Compliance Management comments:

Characters remaining:4000/4000

Overwrite with current OMS data.:

New Active Substance Importation

Active Substance*

Active Substance (English):
Active Substance (NL):
NCA Reference Key:

3rd Country Manufacturer

3rd Country Manufacturer	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

3rd Country Distributor

3rd Country Distributor	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-03-31

RTF Template

National Center For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-CELL
2. Name of Authorisation Holder	:	Celltrion Healthcare Hungary Kft. (ORG-100000826 / LOC-100023306)
3. Address(es) of Site(s)	:	Vasut Utca 13, Budaors, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Westend Office Building B Torony, Vaci Ut 1-3, Budapest VI, 1062
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-06-10
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Celltrion Healthcare Hungary Kft.

(ORG-100000826 / LOC-100023161)

, Vasut Utca 13, Budaors, 2040, Hungary

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Medicinal products with additional requirements
2.2.1. Cold chain store-house ( 2-8 °C)
L004 store-house storage locations:
From E-01-A-01 to E-04-D-02
From G-01-A-01 to G-02-D-02
From G-03-A-01 to G-03-A-03
From G-03-B-01 to G-03-D-03
G-04-B-01, G-04-C-01, G-04-D-01, G-04-E-02, G-04-D-02

BET02 store-house storage locations:
From 2H-01-A-01 to 2H-06-G-03
From 2I-01-A-01 to 2I-06-G-03
From 2J-01-A-01 to 2J-06-G-03
From 2K-01-A-01 to 2K-06-G-03

BET03 store-house storage locations:

From 3A-01-A-01 to 3A-03-H-03
From 3B-01-A-01 to 3B-04-H-03
From 3C-01-A-01 to 3H-08-H-03

Name of responsible person:                 diploma No is:
Dr. Kozik Dávid                                57/2003 (pharmacist)
Dr. Krizbai Sarolta                              621 (pharmacist)

Reason for Withdrawing:

The WD licence was withdrawn because a new modified licence was issued.

Union Format for a Wholesale Distribution Authorisation	HU-D-CELL
	Page 1

Loading, please wait