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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-12-18

RTF Template

Agency for Medicinal Products and Medical Devices of Croatia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	UP/I-530-01/14-01/37; 381-13-04/162-14-04, 381-13-04/162-15-06
2. Name of Authorisation Holder	:	KRKA-FARMA društvo s ograničenom odgovornošću za trgovinu na veliko i malo i vanjsko-trgovinsko poslovanje
3. Address(es) of Site(s)	:	V. Holjevca 20/E, Jastrebarsko, 10450, Croatia

4. Legally registered address of Authorisation Holder	:	Radnička cesta 48, Zagreb, 10000, Croatia
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2014-09-15
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: KRKA-FARMA d.o.o.

, V. Holjevca 20/E, Jastrebarsko, 10450, Croatia

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.4. Other products: Please see under restrictions or clarifying remarks

Any restrictions or clarifying remarks (for all users): Medicinal products from section 3.4 are:
a) Investigational medical products
d) Parallel wholesale distribution
e) Parallel imported medicinal products
f) Traditional herbal medicinal products

Reason for Withdrawing:

The Authorisation Holder has requested the cancellation of the authorisation.

Union Format for a Wholesale Distribution Authorisation	UP/I-530-01/14-01/37; 381-13-04/162-14-04, 381-13-04/162-15-06
	Page 1

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