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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-09-05

RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-NOVA
2. Name of Authorisation Holder	:	Novartis Hungaria Kft. (ORG-100001356 / LOC-100001620)
3. Address(es) of Site(s)	:	Kamaraerdo, Vasut Utca 13, Budaors, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Bartok Bela Ut 43-47, Budapest XI, 1114
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	:	2023-07-07
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: Novartis Hungaria Kft.

(ORG-100001356 / LOC-100007412)

, Kamaraerdo, Vasut Utca 13, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Medicines requiring deep freezing without storage

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 locations:
From A-09-11 to F-11-36
From A-16-11 to F-16-22
From A-41-11 to E-41-11
From A-07-11 to G-07-40
From A-00-01 to D-00-03
From CSOM-11 to CSOM-44

2.2.2 Cold chain (2-8°C) store-house locations:
From A-54-11 to C-55-21

2.2.3 Narcotic or psychotropic products locations:
From A-60-15

Additional provisions based on national requirements.

Name(s) of responsible person(s)

Dr. Pongrácz Zita 52/1999 (pharmacist)
Dr. Dobai Szilvia 12-18/2012(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-NOVA
	Page 1

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