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RTF Template

National Center For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-QPHA
2. Name of Authorisation Holder	:	Q Pharma Kft. (ORG-100003381 / LOC-100028039)
3. Address(es) of Site(s)	:	Naplas Ut 24, Nagytarcsa, 2142, Hungary

4. Legally registered address of Authorisation Holder	:	Naplas Ut 24, Nagytarcsa, 2142
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-10-09
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: Q Pharma Kft.

(ORG-100003381 / LOC-100028039)

, Naplas Ut 24, Nagytarcsa, 2142, 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

Any restrictions or clarifying remarks (for all users): Authorised Wholesale Distribution Operation
2.2. Holding
2.2.1. Ambient warehouse of 15-25 °C storage locations:
NT-A-1-1 → NT-A-1-9 NT-D-1-1 → NT-D-1-3
NT-A-2-1 → NT-A-2-9 NT-D-2-1 → NT-D-2-3
NT-A-3-1 → NT-A-3-8 NT-D-3-1 → NT-D-3-3
NT-B-1-1 → NT-B-1-3 NT-E-1-1 → NT-E-1-3
NT-B-2-1 → NT-B-2-3 NT-E-2-1 → NT-E-2-3
NT-B-3-1 → NT-B-3-3 NT-E-3-1 → NT-E-3-3
NT-C-1-1 → NT-C-1-6 NT-F-1-1 → NT-F-1-2
NT-C-2-1 → NT-C-2-6 NT-K-1-1 → NT-K-1-4
NT-C-3-1 → NT-C-3-6 NT-K-2-1 → NT-K-2-4
NT-K-4-1 → NT-K-4-4

Storage location of not applicable product:

NT-E-1-4/NMF → NT-E-1-6/NMF
NT-E-2-4/NMF → NT-E-2-6/NMF
NT-E-3-4/NMF → NT-E-3-6/NMF

Damaged medicine storage locations:

NT-A-3-9/NT-SELEJT

Additional provisions based on national requirements

Name(s) of responsible person(s) Number of Diplome
Dr. Körösi Gábor János 54/1999 (pharmacist)

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

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

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