Sun 1 Nov 2026 07:43:50 BST

Search Company

OMS Organisation Identifier:

OMS Location Identifier:

NCA Reference Key:

Address:

Country:

Active Substance

New Active Substance

Search Site

Create Site

Update Site

Current data stored in EudraGMDP database

Current data stored in OMS

DUNS Number:

NCA Reference Key:

Site Name:

OMS Organisation Identifier:

OMS Location Identifier:

Address Line 1:

Address Line 2:

Address Line 3:

Address Line 4:

City:

County:

Postcode:

Country:

Additional Details on Units Inspected

Site under Compliance Management:

Compliance Management comments:

Characters remaining:4000/4000

Overwrite with current OMS data.:

New Active Substance Importation

Active Substance*

Active Substance (English):
Active Substance (NL):
NCA Reference Key:

3rd Country Manufacturer

3rd Country Manufacturer	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

3rd Country Distributor

3rd Country Distributor	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-21

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	:	801-3/2024-5
2. Name of Authorisation Holder	:	Swixx Biopharma trgovsko podjetje d.o.o. (ORG-100034450 / LOC-100054588)
3. Address(es) of Site(s)	:	Pot K Sejmiscu 35, Crnuce, Ljubljana, 1231, Slovenia

4. Legally registered address of Authorisation Holder	:	Pot K Sejmiscu 35, Crnuce, Ljubljana, 1231
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	:	2024-02-19
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: Swixx Biopharma trgovsko podjetje d.o.o.

(ORG-100034450 / LOC-100054588)

, Pot K Sejmiscu 35, Crnuce, Ljubljana, 1231, 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

2.4. 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

3.1.1. Narcotic or psychotropic products

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:
- Pot k sejmišču 35, 1231 Ljubljana-Črnuče. Contract for warehouse premises between Swixx Biopharma d.o.o. and NEPREMIČNINE EP d.o.o. valid until 28.02.2025.
- Schenker mednarodna špedicija d.d., Brnčičeva ulica 51, Ljubljana-Črnuče, 1231, Slovenia. Contract for warehouse premises between Swixx Biopharma d.o.o. and Schenker d.d. is valid for indefinite duration.

WDA is valid until 28.02.2025.

Reason for Withdrawing:

New WDA.

Union Format for a Wholesale Distribution Authorisation	801-3/2024-5
	Page 1

Loading, please wait