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RTF Template

Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	801-37/2024-12
2. Name of Authorisation Holder	:	TOROPHARMA distribucija zdravil d.o.o. (ORG-100052785 / LOC-100093022)
3. Address(es) of Site(s)	:	Trzaska Cesta 330, Ljubljana, 1000, Slovenia

4. Legally registered address of Authorisation Holder	:	Trzaska Cesta 330, Ljubljana, 1000, Slovenia
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 Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-11-22
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: TOROPHARMA distribucija zdravil d.o.o.

(ORG-100052785 / LOC-100093022)

, Trzaska Cesta 330, Ljubljana, 1000, Slovenia

Human medicinal products

Veterinary 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

2.5. Other activities(s): (please specify) of medicinal products from EU to RS, Outwards of medicinal products from RS to EU

Any restrictions or clarifying remarks (for all users): Warehouse at: Kemofarmacija d.d., Cesta na Brdo 100, 1000 Ljubljana

Wda is valid until 31.12.2028

*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	801-37/2024-12
	Page 1

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