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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-03-04

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	:	801-24/2024-5
2. Name of Authorisation Holder	:	Medica d.o.o. (ORG-100035696 / LOC-100056543)
3. Address(es) of Site(s)	:	Spruha 44, Trzin, 1236, Slovenia

4. Legally registered address of Authorisation Holder	:	Spruha 44, Trzin, 1236
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-05-28
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: Medica d.o.o.

(ORG-100035696 / LOC-100056543)

, Spruha 44, Trzin, 1236, 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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): WDA is valid until 28. 2. 2025.

Warehouse at Salus, Veletrgovina, d.o.o., Litostrojska cesta 46A, 1000 Ljubljana

Contract for warehouse premises between Medica, medicinska zastopstva, trgovina, marketing in posredovanje, d. o. o. and SALUS, Veletrgovina, družba za promet s farmacevtskimi, medicinskimi in drugimi proizvodi, d.o.o. for indefinite duration.

Contract for business premises between Medica, medicinska zastopstva, trgovina, marketing in posredovanje, d. o. o. and ELDRO d.o.o., Špruha 44, 1236 Trzin valid until 28. 2. 2025.

Reason for Withdrawing:

The company did not apply for a prolongation WDA.

Union Format for a Wholesale Distribution Authorisation	801-24/2024-5
	Page 1

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