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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-09-02

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	:	801-13/2014-2
2. Name of Authorisation Holder	:	NACIONALNI INSTITUT ZA JAVNO ZDRAVJE (ORG-100035800 / LOC-100056693)
3. Address(es) of Site(s)	:	Trubarjeva Cesta 2, Ljubljana, 1000, Slovenia

4. Legally registered address of Authorisation Holder	:	Trubarjeva Cesta 2, 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	:	2014-03-19
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: NACIONALNI INSTITUT ZA JAVNO ZDRAVJE

(ORG-100035800 / LOC-100056693)

, Trubarjeva Cesta 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Warehouse at:
- Nacionalni inštitut za javno zdravje, Trubarjeva cesta 2, Ljubljana, 1000, Slovenia
- SALUS, Veletrgovina, družba za promet s farmacevtskimi, medicinskimi in drugimi proizvodi,
d.o.o., Litostrojska ulica 46A, Ljubljana, 1000, Slovenia

*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

Reason for Withdrawing:

New WDA.

Union Format for a Wholesale Distribution Authorisation	801-13/2014-2
	Page 1

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