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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-11-11

RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-KOMT
2. Name of Authorisation Holder	:	Komtur Pharmaceuticals Hungary Kft. (ORG-100038712 / LOC-100060802)
3. Address(es) of Site(s)	:	Rakospalotai Hatarut 2, Budapest XV, 1152, Hungary

4. Legally registered address of Authorisation Holder	:	Szabadfold Ut 79, Budapest XVI, 1164
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-11-18
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: Komtur Pharmaceuticals Hungary Kft.

(ORG-100038712 / LOC-100063366)

, Rakospalotai Hatarut 2, Budapest XV, 1152, 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

3.3. 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 No. 3.01
2.2.2 Cold chain (2-8°C) store-house No. 2.02

Additional provisions based on national requirements.

Name(s) of responsible person(s)
Kiss Ferencné Dr. 67/1983 (pharmacist)

Reason for Withdrawing:

because new WDA was given

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

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