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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-PHNO
2. Name of Authorisation Holder	:	Pharmanox Kft. (ORG-100002438 / LOC-100002813)
3. Address(es) of Site(s)	:	Malom Koz 4, Szod, 2134, Hungary

4. Legally registered address of Authorisation Holder	:	Erdoalja Utca 6, Batorliget, 4343
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	:	2023-01-17
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: Pharmanox Kft.

(ORG-100002438 / LOC-100018204)

, Malom Koz 4, Szod, 2134, 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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: see in restriction part

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
2.2.2. Drugs, which require special storage condition of 2°C - 8°C
2.2.3. Drugs, which require special storage condition of 8°C - 15°C

3. Medicinal products with additional requirements
3.4. Other products
3.4.1. Homeopathic medicinal products

Additional provisions based on national requirements

Name(s) of Responsible Person(s)       diploma No is:
Dr. Zajzonné Dr Boruzs Hedvig                            16/1974 (pharmacist)
Dr. Szép László Levente                                      81/2001 (pharmacist)
Dr. Velicsek Eszter                                      88/2006 (pharmacist)
Dr. Csorba Dóra                                      17/SE-GYTK-GYO/2021 (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-PHNO
	Page 1

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