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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-530-01/14-01/09; 381-13-04/162-14-04; 381-10-05/284-17-06
2. Name of Authorisation Holder	:	LIGULA PHARMA d.o.o. za promet lijekovima, trgovinu i usluge (LIGULA PHARMA d.o.o.)
3. Address(es) of Site(s)	:	Iblerov trg 7, Zagreb, 10000, Croatia Utinjska ulica 40, Zagreb, 10020, Croatia Plešivička 8, Sveta Nedelja, 10431, Croatia

4. Legally registered address of Authorisation Holder	:	Iblerov trg 7, 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	:	2014-05-23
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: LIGULA PHARMA d.o.o.

, Iblerov trg 7, Zagreb, 10000, Croatia

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

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

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 cool place 8 to 15°C.

Name and address of the site: MEDICAL INTERTRADE d.o.o.

, Plešivička 8, Sveta Nedelja, 10431, Croatia

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

3.3. Cold chain products(requiring low temperature handling)

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.

*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-530-01/14-01/09; 381-13-04/162-14-04; 381-10-05/284-17-06
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