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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-10-01

RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-MAGN
2. Name of Authorisation Holder	:	Magnapharm Hungary Kft. (ORG-100031206 / LOC-100048977)
3. Address(es) of Site(s)	:	Akacos, Hrsz 0221/12 A1 building 17 Gate No 19, Fot, 2151, Hungary

4. Legally registered address of Authorisation Holder	:	Gizella Ut 42-44, Budapest Xiv, 1143
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	:	2022-02-07
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: Magnapharm Hungary Kft.

(ORG-100031206 / LOC-100064409)

, Akacos, Hrsz 0221/12 A1 building 17 Gate No 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): 2.2.1 Holding
Room temperature (15-25°C) storehouse storage locations
FG-8 cold chain (2-8°C) storehouse storage locations

Name of responsible person Diploma No.
Dr. Ladányi Gabriella 38/1997 (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

Reason for Withdrawing:

new WDA was given

Union Format for a Wholesale Distribution Authorisation	HU-D-MAGN
	Page 1

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