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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-01-08

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	:	801-42/2022-3
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
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	:	2022-12-29
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: 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 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

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

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

Reason for Withdrawing:

New WDA.

Union Format for a Wholesale Distribution Authorisation	801-42/2022-3
	Page 1

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