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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-530-03/23-06/21; 381-13-08/353-25-07
2. Name of Authorisation Holder	:	Belupo d.d. (ORG-100003053 / LOC-100007886)
3. Address(es) of Site(s)	:	Ulica Danica 5, Koprivnica, 48000, Croatia

4. Legally registered address of Authorisation Holder	:	Ulica Danica 5, Koprivnica, 48000, Croatia
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	:	2025-02-26
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: Belupo d.d.

(ORG-100003053 / LOC-100007886)

, Ulica Danica 5, Koprivnica, 48000, Croatia

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*

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. 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) Please see Any restrictions or clarifying remarks

Any restrictions or clarifying remarks (for all users): Medicinal products from section 3.3. are: Investigational medicinal products.

Annex 2 Address(es) of contract wholesale distribution sites
2.2 Holding is conducted in a contracted warehouse located at PHOENIX Farmacija d.o.o., 10410 Vukovina, Velika Gorica, Zelena aleja 45, Croatia (ORG-100013354/LOC-100073075), for medicinal products with additional requirement listed under sections 3.1 and 3.3.

*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.

Union Format for a Wholesale Distribution Authorisation	UP/I-530-03/23-06/21; 381-13-08/353-25-07
	Page 1

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