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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-530-01/21-01/06
2. Name of Authorisation Holder	:	Carso Pharm d.o.o. (ORG-100041252 / LOC-100067910)
3. Address(es) of Site(s)	:	Ulica grada Vukovara 284, Zagreb, 10000, Croatia Zelena Aleja 45, Vukovina, Velika Gorica, 10410, Croatia

4. Legally registered address of Authorisation Holder	:	Ulica Grada Vukovara 284, 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	:	2022-10-12
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: CARSO pharm d.o.o.

, Ulica grada Vukovara 284, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Please see clarifications under Annex 1 Remarks

Any restrictions or clarifying remarks (for all users): Medicinal products from section 3.4 are: Investigational medicinal products, Homoeopathic products, Vaccines, Parallel wholesale distribution, Parallel imported medicinal products and Traditional herbal medicinal products.

Name and address of the site: PHOENIX Farmacija d.o.o.

(ORG-100013354 / LOC-100073075)

, Zelena Aleja 45, Vukovina, Velika Gorica, 10410, Croatia

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Please see clarifications under Annex 1 Remarks

*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-530-01/21-01/06
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