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RTF Template

State Institute For Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	D-56/2025
2. Name of Authorisation Holder	:	PHOENIX Zdravotnicke zasobovanie a.s. (ORG-100019671 / LOC-100028427)
3. Address(es) of Site(s)	:	Pribylinska 2 A, Raca, Bratislava, 831 04, Slovakia Lipova 13 And 15, Nesvady, 946 51, Slovakia Presovska Cesta 4, Stare Mesto, Kosice, 040 01, Slovakia Hala Dc6, Dialnicna Cesta 4431, Senec, 903 01, Slovakia Moyzesova 37, Zvolen, 960 01, Slovakia

4. Legally registered address of Authorisation Holder	:	Pribylinska 2 A, Raca, Bratislava, 831 04
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-11-05
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: PHOENIX Zdravotnicke zasobovanie a.s.

(ORG-100019671 / LOC-100028427)

, Pribylinska 2 A, Raca, Bratislava, 831 04, Slovakia

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

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. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Name and address of the site: PHOENIX Zdravotnicke zasobovanie a.s.

(ORG-100019671 / LOC-100088617)

, Lipova 13 And 15, Nesvady, 946 51, Slovakia

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

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. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Name and address of the site: PHOENIX Zdravotnicke zasobovanie a.s.

(ORG-100019671 / LOC-100088654)

, Presovska Cesta 4, Stare Mesto, Kosice, 040 01, Slovakia

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

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. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Name and address of the site: PHOENIX Zdravotnicke zasobovanie a.s.

(ORG-100019671 / LOC-100088653)

, Hala Dc6, Dialnicna Cesta 4431, Senec, 903 01, Slovakia

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

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. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Name and address of the site: PHOENIX Zdravotnicke zasobovanie a.s.

(ORG-100019671 / LOC-100052807)

, Moyzesova 37, Zvolen, 960 01, Slovakia

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

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. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Union Format for a Wholesale Distribution Authorisation	D-56/2025
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