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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-07-01

RTF Template

Agency For Medicinal Products And Medical Devices Of Croatia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	UP/I-530-01/14-01/15; 381-13-08/365-23-14
2. Name of Authorisation Holder	:	Alkaloid d.o.o. (ORG-100001037 / LOC-100018723)
3. Address(es) of Site(s)	:	Slavonska Avenija 6 A, Zagreb, Grad Zagreb, 10000, Croatia

4. Legally registered address of Authorisation Holder	:	Slavonska Avenija 6 A, Zagreb, Grad Zagreb, 10000
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	:	2023-11-15
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: Alkaloid d.o.o.

(ORG-100001037 / LOC-100018723)

, Slavonska Avenija 6 A, Zagreb, Grad Zagreb, 10000, Croatia

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): Contract between ALKALOID d.o.o. and OKTAL PHARMA d.o.o. is in force for wholesale distribution activity: 2.2 Holding. Contracted warehouse at OKTAL PHARMA d.o.o., Utinjska ulica 40, 10000 Zagreb, Croatia (ORG-100001667 / LOC-100008364).

Reason for Withdrawing:

WDA licence has been superseded by a new document due to adding new categories of medicinal products and adding contracted warehouse location.

Union Format for a Wholesale Distribution Authorisation	UP/I-530-01/14-01/15; 381-13-08/365-23-14
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