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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	GIF-P-Z-4302-37/RB/05
2. Name of Authorisation Holder	:	NEUCA S.A.
3. Address(es) of Site(s)	:	Ul. Olchowa 5, Koszalin, 75-136, Poland

4. Legally registered address of Authorisation Holder	:	Forteczna 35-37, Toruń, kujawsko-pomorskie, 87-100, Poland
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	:	2005-09-20
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: Neuca S.A.

(ORG-100019408 / LOC-100037200)

, Ul. Olchowa 5, Koszalin, 75-136, 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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.5. Other activities(s): *Patrz Zastrzeżenia - Uwaga 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, 3.4.3, 3.4.4, 3.4.5

Any restrictions or clarifying remarks (for all users): * Uwaga 2.5 - Usługi logistyczne w zakresie obrotu hurtowego na rzecz podmiotów odpowiedzialnych, wytwórców, importerów i przedsiębiorców zajmujących się obrotem hurtowym produktami leczniczymi.

*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-P-Z-4302-37/RB/05
	Page 1

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