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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-530-03/24-06/02; 381-13-08/382-24-03
2. Name of Authorisation Holder	:	Berlin-Chemie Menarini Hrvatska d.o.o. (ORG-100003356 / LOC-100002683)
2.a. Alternative name of authorisation holder (optional)	:	Berlin-Chemie Menarini Hrvatska d.o.o.
3. Address(es) of Site(s)	:	Horvatova Ulica 80a, Zagreb, 10000, Croatia

4. Legally registered address of Authorisation Holder	:	Horvatova Ulica 80a, Zagreb, 10000
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	:	2024-02-09
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: Berlin-Chemie Menarini Hrvatska d.o.o.

(ORG-100003356 / LOC-100002683)

, Horvatova Ulica 80a, 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

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: 3.4.7 Biological products

Any restrictions or clarifying remarks (for all users): Contract between Berlin-Chemie Menarini Hrvatska d.o.o. and MEDIKA d.d. is in force for wholesale distribution activity: 2.2 Holding.
Contracted warehouse at Medika d.d., Strojarska Cesta 9b, 10361 Sesvetski Kraljevec, Croatia (ORG-100006010 / LOC-100084086)

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	UP/I-530-03/24-06/02; 381-13-08/382-24-03
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