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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-ASTE
2. Name of Authorisation Holder	:	Astellas Pharma Kft. (ORG-100004439 / LOC-100052693)
3. Address(es) of Site(s)	:	Keleti Marton Utca 19, Fot, 2151, Hungary

4. Legally registered address of Authorisation Holder	:	Csorsz Utca 43, Budapest XII, 1124
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	:	2022-10-11
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 Kft.

(ORG-100004439 / LOC-100063257)

, Keleti Marton Utca 19, Fot, 2151, Hungary

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Operation
2.2. Holding:
2.2.1. Room temperature (15-25°C) store-house
2.2.2. Cold chain (2-8°C) store-house

Additional provisions based on national requirements:

Name(s) of responsible person(s)        diploma No is:

Dr. Hegedűs Hanna                                32/1995 (pharmacist)
Dr. Cs. Szabó András                            57/ 2009 (pharmacist)

*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	HU-D-ASTE
	Page 1

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