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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NZOH.5100.93.2022.AKE.6
2. Name of Authorisation Holder	:	Astellas Pharma Sp. z o.o. (ORG-100002208 / LOC-100073928)
3. Address(es) of Site(s)	:	Pass 28, Blonie, 05-870, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Zwirki I Wigury 16c, Warsaw, 02-092
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	:	2022-12-07
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: Astellas Pharma Sp. z o.o.

(ORG-100002208 / LOC-100073728)

, Pass 28, Blonie, 05-870, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: cytotoxic medicinal products, medicinal products with very strong effect cytostatyki, produkty lecznicze bardzo silnie dziłajace

Any restrictions or clarifying remarks (for all users): Obrót produktami leczniczymi, dla których Astellas Pharma Sp. z o. o. jest podmiotem
odpowiedzialnym lub przedstawicielem podmiotu odpowiedzialnego – spółki Astellas Pharma Europe
B.V.
Obrót produktami leczniczymi z zimnego łańcucha dostaw obejmujący wyłącznie cytostatyczne
produkty lecznicze.

*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	NZOH.5100.93.2022.AKE.6
	Page 1

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