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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

1. Authorisation Number	:	801-8/2024-6
2. Name of Authorisation Holder	:	KUEHNE + NAGEL globalni logisticni servis d.o.o. (ORG-100035625 / LOC-100056422)
3. Address(es) of Site(s)	:	Zgornji Brnik 300, Aerodrom, Brnik, 4210, Slovenia

4. Legally registered address of Authorisation Holder	:	Zgornji Brnik 300, Aerodrom, Brnik, 4210
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
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-04-18
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: KUEHNE + NAGEL globalni logisticni servis d.o.o.

(ORG-100035625 / LOC-100056422)

, Zgornji Brnik 300, Aerodrom, Brnik, 4210, Slovenia

Human medicinal products

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

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

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Flammable substances, dangerous substances and herbal substances

Any restrictions or clarifying remarks (for all users): WDA is valid until 1.7.2028.

Contract for registered office and business premises between KUEHNE + NAGEL, d.o.o. and SCPI CORUM ORIGIN, 1 rue Euler, 75008 Pariz, Francija. is valid until 1.7.2028.

Contract for warehouse premises between KUEHNE + NAGEL,d.o.o. and SCPI CORUM ORIGIN, 1 rue Euler, 75008 Pariz, Francija is valid until 1.7.2028.

*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	801-8/2024-6
	Page 1

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