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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-65/2025
2. Name of Authorisation Holder	:	UNIPHARMA 1 slovenska lekarnicka a.s. (ORG-100009516 / LOC-100014636)
3. Address(es) of Site(s)	:	Opatovska Cesta 4, Bojnice, 972 01, Slovakia Budatinska 18, Petrzalka, Bratislava, 851 06, Slovakia Roznavska 2, Ruzinov, Bratislava, 821 04, Slovakia Safarikova 2/a, Presov, 080 01, Slovakia

4. Legally registered address of Authorisation Holder	:	Opatovska Cesta 4, Bojnice, 972 01
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	:	2025-05-28
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: UNIPHARMA 1 slovenska lekarnicka a.s.

(ORG-100009516 / LOC-100014636)

, Opatovska Cesta 4, Bojnice, 972 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) - 40˚ C

Name and address of the site: UNIPHARMA 1 slovenska lekarnicka a.s.

(ORG-100009516 / LOC-100017918)

, Budatinska 18, Petrzalka, Bratislava, 851 06, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Name and address of the site: UNIPHARMA 1 slovenska lekarnicka a.s.

(ORG-100009516 / LOC-100017921)

, Roznavska 2, Ruzinov, Bratislava, 821 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Name and address of the site: UNIPHARMA 1 slovenska lekarnicka a.s.

(ORG-100009516 / LOC-100017920)

, Safarikova 2/a, Presov, 080 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	D-65/2025
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