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RTF Template

Agency for Medicinal Products and Medical Devices for Croatia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	UP/I-530-01/14-01/15; 381-13-04/162-14-04
2. Name of Authorisation Holder	:	ALKALOID društvo s ograničenom odgovornošću za promet na veliko lijekovima i pomoćnim ljekovitim sredstvima (ALKALOID d.o.o.)
3. Address(es) of Site(s)	:	Utinjska ulica 40, Zagreb, 10020, Croatia

4. Legally registered address of Authorisation Holder	:	Avenija grada Vukovara 226/f, Zagreb, 10000, Croatia
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2014-05-29
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: OKTAL PHARMA d.o.o.

, Utinjska ulica 40, Zagreb, 10020, Croatia

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

*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-530-01/14-01/15; 381-13-04/162-14-04
	Page 1

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