Sun 25 Oct 2026 01:50:13 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.

RTF Template

National Centre 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, Hungary
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	:	2025-01-30
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 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2.1. Temperatures between 2 to 8 °C

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:

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-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

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

**Without prejudice to further authorisations as may be required according to national legislation.

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

Loading, please wait