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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-530-01/13-01/20; 381-13-08/60-23-26
2. Name of Authorisation Holder	:	Novo Nordisk Hrvatska d.o.o. (ORG-100000863 / LOC-100008362)
3. Address(es) of Site(s)	:	Ulica Damira Tomljanovica - Gavrana 17, Zagreb, Grad Zagreb, 10000, Croatia

4. Legally registered address of Authorisation Holder	:	Ulica Damira Tomljanovica - Gavrana 17, Zagreb, Grad 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	:	2023-08-10
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: Novo Nordisk Hrvatska d.o.o.

(ORG-100000863 / LOC-100008362)

, Ulica Damira Tomljanovica - Gavrana 17, 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

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: See Annex 1 restrictions and clarifying remarks

Any restrictions or clarifying remarks (for all users): Medicinal products from section 3.4. are: Investigational medicinal products and Biological products.
Contract between NOVO NORDISK Hrvatska d.o.o. and MEDICAL INTERTRADE d.o.o. is in force for wholesale distribution activities: 2.2 Holding.
Contracted warehouse at MEDICAL INTERTRADE d.o.o., Plešivička 8, 10431 Sveta Nedjelja, Croatia (ORG-100001426 / LOC-100008327).

*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-530-01/13-01/20; 381-13-08/60-23-26
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