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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	OGYÉI/4390-2/2020
2. Name of Authorisation Holder	:	BUS-OXY Egészségügyi Gázforgalmazó Szolgáltató és Kereskedelmi Kft.
3. Address(es) of Site(s)	:	Északi Ipartelep I., Alsónémedi, 2351, Hungary Rákóczi F. u. 29., Kisbér, 2870, Hungary Dinnyés u. 5., Szeged, Kiskundorozsma, 6791, Hungary Juhász Gy. u. 4., Dombóvár, 7200, Hungary Eperfa u. 12., Jászberény, 5100, Hungary Kossuth Lajos u. 2.A, Sümegprága, 8351, Hungary Árpád u. 18., Polgár, 4090, Hungary

4. Legally registered address of Authorisation Holder	:	Kanyargó u. 25., Budapest, 1221, Hungary
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-01-29
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: BUS-OXY Egészségügyi Gázforgalmazó Szolgáltató és Kereskedelmi Kft.

, Északi Ipartelep I., Alsónémedi, 2351, Hungary

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

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): Name of responsible person                 diploma No :
Tancsikné dr. Molnár Lujza                    77/1968 (pharmacist)
dr. Morvay Malgorzata Rozália               2639 (pharmacist)
dr. Kovács Zsuzsanna                           44/1979 (pharmacist)
dr. Sárkány Ferenc                                97/1994 (pharmacist)

Name and address of the site: BUS-OXY Egészségügyi Gázforgalmazó Szolgáltató és Kereskedelmi Kft.

, Rákóczi F. u. 29., Kisbér, 2870, Hungary

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

3.2. Medicinal gases

Name and address of the site: BUS-OXY Egészségügyi Gázforgalmazó Szolgáltató és Kereskedelmi Kft.

, Dinnyés u. 5., Szeged, Kiskundorozsma, 6791, Hungary

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

3.2. Medicinal gases

Name and address of the site: BUS-OXY Egészségügyi Gázforgalmazó Szolgáltató és Kereskedelmi Kft.

, Juhász Gy. u. 4., Dombóvár, 7200, Hungary

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

3.2. Medicinal gases

Name and address of the site: BUS-OXY Egészségügyi Gázforgalmazó Szolgáltató és Kereskedelmi Kft.

, Eperfa u. 12., Jászberény, 5100, Hungary

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

3.2. Medicinal gases

Name and address of the site: BUS-OXY Egészségügyi Gázforgalmazó Szolgáltató és Kereskedelmi Kft.

, Kossuth Lajos u. 2.A, Sümegprága, 8351, Hungary

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

3.2. Medicinal gases

Name and address of the site: BUS-OXY Egészségügyi Gázforgalmazó Szolgáltató és Kereskedelmi Kft.

, Árpád u. 18., Polgár, 4090, Hungary

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

3.2. Medicinal gases

*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	OGYÉI/4390-2/2020
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