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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-09-09

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	:	801-13/2025-3
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	:	2025-04-29
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 or registration in EEA country(s)

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration 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): (please specify) Entry of medicinal products from EU to RS, Outwards of medicinal products from RS to EU

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) *** -25⁰C to -15⁰C

3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products, Medicinal products derived from blood

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 28.02.2030.
- 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.
- Kemofarmacija d.d., Cesta na Brdo 100, 1000 Ljubljana
*** Products requiring low temperature handling (-25⁰C to -15⁰C, only in warehouse Kemofarmacija d.d., Cesta na Brdo 100, 1000 Ljubljana).

WDA is valid until 17.05.2026.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

**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	801-13/2025-3
	Page 1

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