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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	:	801-4/2023-4
2. Name of Authorisation Holder	:	GENOS, Podjetje za trgovino, zastopstva in storitve d.o.o.
3. Address(es) of Site(s)	:	Trg Osvobodilne Fronte 14, Ljubljana, 1000, Slovenia

4. Legally registered address of Authorisation Holder	:	Trg Osvobodilne fronte 14, Ljubljana, 1000
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	:	2023-04-05
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: Genos d.o.o.

(ORG-100035479 / LOC-100056231)

, Trg Osvobodilne Fronte 14, 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

3.1.4. Radiopharmaceuticals (including radionuclide kits)

Any restrictions or clarifying remarks (for all users): Warehouse at Farmadent trgovina, proizvodnja in storitve d.o.o., Minařikova ulica 6, Maribor, 2000, Slovenia.

Contract for warehouse premises between GENOS d.o.o. and FARMADENT 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	801-4/2023-4
	Page 1

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