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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-02-21

RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	HU-D-EGIS
2. Name of Authorisation Holder	:	Egis Gyógyszergyár Zrt./Egis Pharmaceuticals Plc.
3. Address(es) of Site(s)	:	Bökényföldi út 116-120. „805-806. épület", Budapest, 1165, Hungary Károlyi Sándor u. 121. "O épület/1. raktár", Budapest, 1151, Hungary

4. Legally registered address of Authorisation Holder	:	Keresztúri út 30-38., Budapest, 1106, Hungary
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-02-09
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: Egis Gyógyszergyár Zrt./Egis Pharmaceuticals Plc.

, Bökényföldi út 116-120. „805-806. épület", Budapest, 1165, Hungary

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)

3.4. Other products: See in restriction part.

Any restrictions or clarifying remarks (for all users): 3.3 Cold chain products 2-8 °C
3.4.3 Drugs with special storage conditions 8-15°C
Additional provisions based on national requirements
Name of responsible person:                             diploma No :
Dr. Wiszkidenszky Alice Zsuzsanna            124/1994 (pharmacist)
Dr. Rácz Rita                                             49/2006 (pharmacist)

Name and address of the site: Egis Gyógyszergyár Zrt./Egis Pharmaceuticals Plc.

, Károlyi Sándor u. 121. "O épület/1. raktár", Budapest, 1151, Hungary

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

2.2. Holding

Any restrictions or clarifying remarks (for all users): Additional provisions based on national requirements
Name of responsible person: diploma No :
Csizi Júlia Ivett 144/2005 (chemist), BMESZ-0538/2020 (specialized training)

Reason for Withdrawing:

The WD licence was withdrawn because a new modified licence was issued.

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

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