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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-09-24

RTF Template

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

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	801-36/2023-3
2. Name of Authorisation Holder	:	AMGEN ZDRAVILA trzenje zdravil d.o.o. (ORG-100010971 / LOC-100073553)
3. Address(es) of Site(s)	:	Ameriska Ulica 2, Ljubljana, 1000, Slovenia

4. Legally registered address of Authorisation Holder	:	Ameriska Ulica 2, Ljubljana, 1000
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	:	2023-10-23
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: AMGEN ZDRAVILA trzenje zdravil d.o.o.

(ORG-100010971 / LOC-100073553)

, Ameriska Ulica 2, Ljubljana, 1000, Slovenia

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): WDA is valid until 31.10.2025.

Warehouse at SALUS Veletrgovina d.o.o., Ljubljana, Litostrojska cesta 46A, 1000 Ljubljana.

Contract for warehouse premises between Amgen zdravila, trženje zdravil, d.o.o. and SALUS Veletrgovina d.o.o., valid until 31.10.2025.

Reason for Withdrawing:

New WDA.

Union Format for a Wholesale Distribution Authorisation	801-36/2023-3
	Page 1

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