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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The WDA has been withdrawn, withdrawn date is: 2025-09-09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	:	801-11/2025-5
2. Name of Authorisation Holder	:	LENIS farmacevtika d.o.o.
3. Address(es) of Site(s)	:	Litostrojska Cesta 52, Ljubljana, 1000, Slovenia

4. Legally registered address of Authorisation Holder	:	Litostrojska cesta 52, Ljubljana, 1000
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	:	2025-04-28
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: LENIS farmacevtika d.o.o.

(ORG-100008841 / LOC-100043724)

, Litostrojska Cesta 52, Ljubljana, 1000, 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

3.3. Other products: (please specify here or make a reference to Annex 5) Immunological medicinal products

Any restrictions or clarifying remarks (for all users): WDA is valid until 30.04.2026.

Warehouse at Kemofarmacija, veletrgovina za oskrbo zdravstva, d.d., Cesta na Brdo 100, Ljubljana, 1000, Slovenia

*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	801-11/2025-5
	Page 1

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