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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-02-21

RTF Template

National Center For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-ZENT
2. Name of Authorisation Holder	:	Zentiva Pharma Kft.
3. Address(es) of Site(s)	:	Kenderföldek utca 3., Csongrád, 6640, Hungary

4. Legally registered address of Authorisation Holder	:	Könyves Kálmán körút 11/C, Budapest, 1097
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	:	2023-10-11
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: Zentiva Pharma Kft.

, Kenderföldek utca 3., Csongrád, 6640, 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

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.Authorised Wholesale Distribution Operation
2.2. Holding
2.2.1. Room temperature (15-25°C) store-house storage locations:

A-001-A to A-038-D
C-007-A to C-030-D
C-031-A to C-054-D
C-007-E to C-012-E
C-052-E to C-054-E
D-001-A to D-090-D
D-001-E to D-012-E
D-079-E to D-090-E
E-001-A to E-094-D
E-001-E to E-012-E
E-083-E to E-094-E
G-001-A to G-009-E
G-010-A to G-027-D
G-032-A to G-046-D
G-047-A to G-052-E

2.2.2. Cold chain (2-8°C) store-house storage locations:

X-007-A to X-012-F

Additional provisions based on national requirements:

Name(s) of responsible person(s)    diploma No is:

Seresné Dr. Terjék Aranka                       88/2004 (pharmacist)
Szólik Vivien                                          BMESZ-0425/2023

Reason for Withdrawing:

The WD licence was withdrawn because a new modified licence was issued.

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

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