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RTF Template


National Centre 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

:

2025-10-14

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 or registration in EEA country(s)

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 

   2.5. Other activities(s): (please specify) Transport


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 




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)



*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.













Union Format for a Wholesale Distribution Authorisation

HU-D-CELL


Page 1





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