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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-N-4111/77/MP/10
2. Name of Authorisation Holder	:	Phoenix Pharma Polska Sp. z o.o. (ORG-100019895 / LOC-100053766)
3. Address(es) of Site(s)	:	Ul. Poludniowa 2, Oltarzew, Ozarow Mazowiecki, 05-850, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Rajdowa 9, Konotopa, Ozarow Mazowiecki, 05-850
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	:	2010-07-22
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: Phoenix Pharma Polska Sp. z o.o.

(ORG-100019895 / LOC-100072603)

, Ul. Poludniowa 2, Oltarzew, Ozarow Mazowiecki, 05-850, Poland

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

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): Patrz Zastrzeżenia uwaga pkt 2.5

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: 3.4.1, 3.4.2, 3.4.4

Any restrictions or clarifying remarks (for all users): Zastrzeżenia pkt 2.5 - usługi logistyczne w zakresie obrotu hurtowego na rzecz podmiotów odpowiedzialnych, wytwórców, importerów i przedsiębiorców zajmujących się obrotem hurtowym.
Pkt 3.4.2 ograniczony tylko do produktu leczniczego Condyline 5mg/ml roztwór na skórę 3,5 ml

*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	GIF-N-4111/77/MP/10
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