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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	:	801-56/2024-3
2. Name of Authorisation Holder	:	BAYER farmacevtska druzba d.o.o. (ORG-100000600 / LOC-100008403)
3. Address(es) of Site(s)	:	Bravnicarjeva Ulica 13, Ljubljana, 1000, Slovenia

4. Legally registered address of Authorisation Holder	:	Bravnicarjeva Ulica 13, 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	:	2025-01-07
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: BAYER farmacevtska druzba d.o.o.

(ORG-100000600 / LOC-100008403)

, Bravnicarjeva Ulica 13, 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

3.2. 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) Radiopharmaceuticals (including radionuclide kits)

Any restrictions or clarifying remarks (for all users): WDA is valid until 31.12.2028.

Contract for warehouse premises between BAYER d.o.o. and DSV Transport d.o.o. valid until 31. 12. 2028.
Warehouse at BAYER farmacevtska druzba d.o.o. (ORG-100000600 / LOC-100009591), Struzevo 90, Kranj, 4000, Slovenia

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

Union Format for a Wholesale Distribution Authorisation	801-56/2024-3
	Page 1

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