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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-530-03/24-06/26; 381-13-08/353-24-02
2. Name of Authorisation Holder	:	PHOENIX Farmacija d.o.o. (ORG-100013354 / LOC-100091836)
3. Address(es) of Site(s)	:	Jezdovecka Ulica 143, Jezdovec, Lucko, 10250, Croatia

4. Legally registered address of Authorisation Holder	:	Jezdovecka Ulica 143, Jezdovec, Lucko, 10250, Croatia
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	:	2024-11-26
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: PHOENIX Farmacija d.o.o.

(ORG-100013354 / LOC-100091836)

, Jezdovecka Ulica 143, Jezdovec, Lucko, 10250, 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*

1.3. without a Marketing Authorisation or registration 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. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.3. Other products: (please specify here or make a reference to Annex 5) See Annex 1 Remarks

Any restrictions or clarifying remarks (for all users): Medicinal products from section 3.3 are: Medicinal products derived from blood, Immunological medicinal products, Investigational medicinal products, Homoeopathic products, Vaccines, Parallel wholesale distribution, Parallel imported medicinal products, Traditional herbal medicinal products, Biological products and Advance Therapeutic Medicinal products.

*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-530-03/24-06/26; 381-13-08/353-24-02
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