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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-530-03/24-06/30; 381-13-08/364-25-03
2. Name of Authorisation Holder	:	Pharma One d.o.o. (ORG-100041853 / LOC-100079922)
3. Address(es) of Site(s)	:	Berislaviceva Ulica 13, Zagreb, Grad Zagreb, 10000, Croatia

4. Legally registered address of Authorisation Holder	:	Berislaviceva Ulica 13, Zagreb, Grad Zagreb, 10000, 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	:	2025-03-14
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: Pharma One d.o.o.

(ORG-100041853 / LOC-100079922)

, Berislaviceva Ulica 13, Zagreb, Grad Zagreb, 10000, 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

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Entry/import in exceptional cases, Parallel wholesale distribution and Parallel imported medicinal

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between 8 to 15°C

3.3. Other products: (please specify here or make a reference to Annex 5) Please see restrictions or clarifying remarks

Any restrictions or clarifying remarks (for all users): Medicinal products from section 3.3 are:Medicinal products derived from blood, Immunological medicinal products and Biological products.
2.2 Holding is conducted in contracted warehouses located at: OKTAL PHARMA d.o.o. Utinjska ulica 38, 10020 Zagreb, Republika Hrvatska (ORG-100001667 / LOC-100068170) i OKTAL PHARMA d.o.o., Utinjska ulica 40, 10020 Zagreb, Republika Hrvatska (ORG-100001667 / LOC-100008364).OKTAL PHARMA d.o.o. (ORG-100001667 / LOC-100068170), Utinjska ulica 38, 10020 Zagreb, Croatia and OKTAL PHARMA d.o.o., (ORG-100001667 / LOC-100008364) Utinjska ulica 40, 10020 Zagreb, Croatia.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	UP/I-530-03/24-06/30; 381-13-08/364-25-03
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