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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	:	NNGYK/31343-8/2024
2. Name of Authorisation Holder	:	Pharma Pack Hungary Kft. (ORG-100004980 / LOC-100089055)
3. Address(es) of Site(s)	:	Building B, Raktarvarosi Ut 9, Torokbalint, 2045, Hungary

4. Legally registered address of Authorisation Holder	:	Building B, Raktarvarosi Ut 9, Torokbalint, 2045
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	:	2025-05-15
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: Pharma Pack Hungary Kft.

(ORG-100004980 / LOC-100089055)

, Building B, Raktarvarosi Ut 9, Torokbalint, 2045, 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): 2. Authorised Wholesale Distribution Operation
2.2 Holding

2.2.1 Room temperature (15-25°C) store-house storage locations:

H01-01-A01-tól – H01-08-E02-ig
H01-01-F01-tól – H01-02-F03-ig
C02-A1-A01-tól – C02-02-A03-ig

Additional provisions based on national requirements

Name of responsible person Number of the diploma

Dr. Szelezsán János    Number of the diploma: GYTk-00066/2012/OKL (pharmacist)
Urbánné dr. Csorba Dóra   Number of the diploma: 17/SE-GYTK-GYO/2021 (pharmacist)
Dr. Király Krisztián            Number of the diploma: 31/2015 (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	NNGYK/31343-8/2024
	Page 1

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