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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-10-06

RTF Template

National Centre For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-PHYT
2. Name of Authorisation Holder	:	Phytotec Hungaria Bt. (ORG-100002618 / LOC-100001667)
3. Address(es) of Site(s)	:	Tunderfurt Utca 13-15, Budapest X, 1106, Hungary

4. Legally registered address of Authorisation Holder	:	Szilagyi Erzsebet Fasor 61, Budapest II, 1026
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	:	2025-06-02
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: Phytotec Hungaria Bt.

(ORG-100002618 / LOC-100007513)

, Tunderfurt Utca 13-15, Budapest X, 1106, 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

Any restrictions or clarifying remarks (for all users): .
Any restriction or clarifying remarks related to the scope of these wholesaling operations

2. Authorised Wholesale Distribution Operation
2.2. Holding
2.2.1 Room temperature (15-25°C) store-house storage locations

Additional provisions based on national requirements
Name of Responsible Person Diplom No.
Dr. Tasi Vanda 57/2023/GY (pharmacist)

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

Reason for Withdrawing:

new one issued

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

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