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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-EURH
2. Name of Authorisation Holder	:	European Pharma Hub Ltd. (ORG-100014094 / LOC-100053291)
3. Address(es) of Site(s)	:	Gorcsev Ivan Utca 5, Gyal, 2360, Hungary

4. Legally registered address of Authorisation Holder	:	Gorcsev Ivan Utca 5, Gyal, 2360
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	:	2022-03-24
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: European Pharma Hub Ltd.

(ORG-100014094 / LOC-100053291)

, Gorcsev Ivan Utca 5, Gyal, 2360, 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

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

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:

16NB1601-02
16NB1701-02

2.2.2. Cold chain (2-8°C) store-house No. 6. storage locations:

16HB1001
16HB1101

Additional provisions based on national requirements:
Name(s) of responsible person(s)                         Diploma No(s)
         Dr. Radeczky Kristóf          83/SE-GYTK-GYO/2018 (pharmacist)
         Dr. Balogh Lili                          4/SE-GYTK-GYO/2019 (pharmacist)
         Dr. Laurinyecz Róbert          30/2009 (pharmacist)
         Dr. Radeczky Géza          65/1982 (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-EURH
	Page 1

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