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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-MARI
2. Name of Authorisation Holder	:	Mario Pharma Kft. (ORG-100048061 / LOC-100079491)
3. Address(es) of Site(s)	:	Lorinci Ut 154, Airport City Logisztikai Park, D Ep 3. Em., Vecses, 2220, Hungary

4. Legally registered address of Authorisation Holder	:	Dozsa Gyorgy Utca 93, Mor, 8060
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	:	2023-10-11
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: Mario Pharma Kft.

(ORG-100048061 / LOC-100080318)

, Lorinci Ut 154, Airport City Logisztikai Park, D Ep 3. Em., Vecses, 2220, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.2 Holding
D-02-2 room temperature store-house (15-25°C) storage locations

D02-2 28 B1
D02-2 28 A1-1
D02-2 28 A1-2
D02-2 28 A1-3
D02-2 28 A1-4

Waste stocks locations:
D02-2 SCP03

D-02-4 cold chain (2-8°C) store-house storage locations
D02-4 37 A1
D02-4 37 A2
D02-4 37 B1

Name of the responsible person No. Diplom
Dr. Sánta Zsuzsanna 74/1988 (phamracist)

*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-MARI
	Page 1

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