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RTF Template

Agency for Medicinal Products and Medical Devices of Croatia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	UP/I-530-01/14-01/71; 381-13-04/162-14-06
2. Name of Authorisation Holder	:	KAJFEŠPHARM d. o. o. za trgovinu
3. Address(es) of Site(s)	:	Črnjina 44, Pula, 52100, Croatia

4. Legally registered address of Authorisation Holder	:	Liburnijska 13, Pula, 52100, 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	:	2014-05-15
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: KAJFEŠPHARM d. o. o.

, Črnjina 44, Pula, 52100, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Annex 1 Remarks

Any restrictions or clarifying remarks (for all users): Medicinal products from section 3.3 that require cold chain storage are kept in a very cool place 2 to 8°C.

Medicinal products from section 3.4.:
b)Homeopathic products
c) Vaccines
d) Parallel wholesale distribution
e) Parallel imported medicinal products
f) Traditional herbal medicinal 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-530-01/14-01/71; 381-13-04/162-14-06
	Page 1

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