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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	:	801-27/2017-12
2. Name of Authorisation Holder	:	FARMEDICA Trgovsko podjetje d.o.o. Ljubljana (ORG-100000015 / LOC-100001842)
3. Address(es) of Site(s)	:	Leskoskova Cesta 12, Ljubljana, 1000, Slovenia

4. Legally registered address of Authorisation Holder	:	Leskoskova Cesta 12, 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
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2017-07-06
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: FARMEDICA Trgovsko podjetje d.o.o. Ljubljana

(ORG-100000015 / LOC-100001842)

, Leskoskova Cesta 12, 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

2.4. 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

3.4. Other products: Herbal substances

Any restrictions or clarifying remarks (for all users): Warehouse at:
- Kemofarmacija, veletrgovina za oskrbo zdravstva, d.d., Cesta na Brdo 100, Ljubljana,
1000,Slovenia
- SALUS, Veletrgovina, družba za promet s farmacevtskimi, medicinskimi in drugimi
proizvodi, d.o.o., Litostrojska ulica 46A, Ljubljana, 1000, Slovenia

Contract for warehouse premises between FARMEDICA d.o.o. and KEMOFARMACIJA d.d. for indefinite duration.
Contract for warehouse premises between FARMEDICA d.o.o. and SALUS d.o.o. for indefinite duration.

*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	801-27/2017-12
	Page 1

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