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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-GLAC
2. Name of Authorisation Holder	:	Glaxosmithkline-Consumer Kft. (ORG-100001858 / LOC-100001668)
3. Address(es) of Site(s)	:	Kamaraerdo, Akron Utca 1, Budaors, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Csorsz Utca 43/XII, XII Kerulet, Budapest, 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: Glaxosmithkline-Consumer Kft.

(ORG-100001858 / LOC-100007438)

, Kamaraerdo, Akron Utca 1, Budaors, 2040, 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

Any restrictions or clarifying remarks (for all users): 2.Authorised Wholesale Distribution Operation
2.2. Holding
2.2.1. Room temperature store-house (15-25°C ) .
Room temperature store-house (15-25°C) No CP9. :
9J01A-9J23J, 9J57A-9J76J, 9I01A-9I76H, 9H01A-9H76H, 9G01A-9G76H, 9F01A-9F73H, 9A01A-9A76H, 9B01A-9B17H, 9B50A-9B73H, 9D25A-9D52H
9D21D-9D24H, 9D76A-9D73G, 9D56D-9D53H, 9C01C-9C24G, 9C76A-9C53H, 9B35A-9B18H, 9B36A-9B49H
Room temperature store-house (15-25°C) No CP4. :
4J01A-4J76H, 4I01A-4I76H, 4H01A-4H76h, 4G01A-4G76H

Additional provisions based on national requirements

Name(s) of responsible person(s)
Dr. Auner Alíz                       87/1997 (pharmacist)
Dr. Simon Edit                      88/2002 (pharmacist)
Dr. Joó Barbara                    29/2008 (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-GLAC
	Page 1

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