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RTF Template

National Center For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-BIOG
2. Name of Authorisation Holder	:	Biogen Hungary Kft. (ORG-100038861 / LOC-100075376)
3. Address(es) of Site(s)	:	Tunderfurt Utca 13-15, Budapest X, 1106, Hungary

4. Legally registered address of Authorisation Holder	:	Bocskai Ut 134-146 E Ep 2 Em, Budapest, 1113, Hungary
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	:	2024-09-02
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: Biogen Hungary Kft.

(ORG-100038861 / LOC-100063296)

, Tunderfurt Utca 13-15, Budapest X, 1106, 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): Authorised Wholesale Distribution Operation
2.2 Holding:
2.2.1. Room temperature (15-25°C) store-house
-storage locations in D warehouse hall of BLK2 warehouse
D2-10-A-1 – D2-10-G-3
BIHMINTA5-BIHMINTA10

2.2.2 Cold rooms (2-8°C)
-storage locations in E warehouse hall and Cold room I. (2-8°C) of BLK2 warehouse
E2-10-A-1 – E2-10-G-3
E2-11-A-1 – E2-11-G-3
BIHMINTA1- BIHMINTA4

Additional provisions based on national requirements

Name(s) of responsible person(s)                    diploma No is:
Dr. Pogány Glória Angelika                         76/SE-GYTK-GYO/2020 (pharmacist)
Dr. Szabó Gabriella                                     OGY/L-72/2007 (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-BIOG
	Page 1

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