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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-530-01/16-01/01
2. Name of Authorisation Holder	:	Betamed d.o.o. (ORG-100038238 / LOC-100060200)
3. Address(es) of Site(s)	:	Ksaver 120, Zagreb, 10000, Croatia

4. Legally registered address of Authorisation Holder	:	Ksaver 120, 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	:	2016-03-02
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: BETAMED d.o.o., 10000 Zagreb, Ksaver 120

, Ksaver 120, Zagreb, 10000, Croatia

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: see restrictions and remarks field

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 and kept in a cold place 8 to 15 °C.

Medicinal products from section 3.4 are:
a) Medicinal products for clinical trials
b) Homeopathic products
c) Vaccines
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-530-01/16-01/01
	Page 1

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