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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-IZIN
2. Name of Authorisation Holder	:	Izinta Kereskedelmi Kft. (ORG-100005726 / LOC-100002265)
3. Address(es) of Site(s)	:	Konkoly-Thege Miklos Ut 29-33, Budapest XII, 1121, Hungary

4. Legally registered address of Authorisation Holder	:	Konkoly-Thege Miklos Ut 29-33, Budapest XII, 1121
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	:	2025-06-16
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: Izinta Kereskedelmi Kft.

(ORG-100005726 / LOC-100002265)

, Konkoly-Thege Miklos Ut 29-33, Budapest XII, 1121, 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

3.3. Other products: (please specify here or make a reference to Annex 5) Radiopharmaceuticals (including radionuclide kits)

Any restrictions or clarifying remarks (for all users): The warehouses were located in
Building XV. Ground Floor 19.
Building XXVIII/A

Additional provisions based on national requirements
Responsible person: diploma No is:
Dr. Szabó Gabriella 90/2002 (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-IZIN
	Page 1

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