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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	:	801-28/2023-3
2. Name of Authorisation Holder	:	InnoPharma trgovina in storitve d.o.o. (ORG-100035516 / LOC-100083068)
3. Address(es) of Site(s)	:	Tehnoloski Park 20, Ljubljana, 1000, Slovenia

4. Legally registered address of Authorisation Holder	:	Tehnoloski Park 20, 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	:	2023-08-23
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: InnoPharma trgovina in storitve d.o.o.

(ORG-100035516 / LOC-100083068)

, Tehnoloski Park 20, Ljubljana, 1000, 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

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

Any restrictions or clarifying remarks (for all users): Conract for bussines premises between InnoPharma trgovina in storitve d.o.o., Tehnološki park 20, 1000 Ljubljana and Jaka Lindič, poslovno svetovanje s.p., Bergantova 10, 1000 Ljubljana is valid for idenfinite duration.
Contract for warehouse premises between InnoPharma trgovina in storitve d. o. o., Tehnološki park 20, 1000 Ljubljana and Kemofarmacija, veletrgovina za oskrbo zdravstva, d.d., Cesta na Brdo 100, 1000 Ljubljana is valid for indefinite duration.
WDA is valid 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	801-28/2023-3
	Page 1

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