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The WDA has been withdrawn, withdrawn date is: 2025-02-21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

Human medicinal products

1. Authorisation Number	:	HU-D-MEDG
2. Name of Authorisation Holder	:	MEDIMPEX Gyógyszer-nagykereskedelmi Zártkörűen Működő Részvénytársaság
3. Address(es) of Site(s)	:	Rákospalotai határút 2., 2-es, 2.01-es, 2.02-es raktár, 1-es és 2-es kapu, Budapest, 1158, Hungary Tündérfürt u. 13-15., Budapest, 1106, Hungary

4. Legally registered address of Authorisation Holder	:	Rákospalotai határút 2., Budapest, 1158
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	:	2022-09-08
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: Medimpex Gyógyszer-nagykereskedelmi Zártkörűen Működő Részvénytársaság

, Rákospalotai határút 2., 2-es, 2.01-es, 2.02-es raktár, 1-es és 2-es kapu, Budapest, 1158, 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)

3.4. Other products: 3.4.1 Homeopathic medicinal products; 3.4.2 Drugs requiring special storage conditions of 8-15 °C

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
Storage location of not applicable product
2.2.2 Drugs, which requires special storage condition (8°C-15°C)
2.2.3 Drugs, which requires special storage condition (2°C-8°C)

Additional provisions based on national requirements.

Name(s) of responsible person(s)
dr. Péter-Ölbey Katalin 63/2010 (Pharmacist))
dr. Kiss Ferencné 67/1983 (pharmacist)

Name and address of the site: Medimpex Gyógyszer-nagykereskedelmi Zártkörűen Működő Részvénytársaság

, Tündérfürt u. 13-15., Budapest, 1106, 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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal 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
2.2.2 Drugs, which requires special storage condition (2°C-8°C)

Additional provisions based on national requirements

Name(s) of responsible person(s)
dr. Husanyica Henrietta 30/2000 (pharmacist)

Reason for Withdrawing:

The WD licence was withdrawn because a new modified licence was issued.

Union Format for a Wholesale Distribution Authorisation	HU-D-MEDG
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