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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-05-26

RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	HU-D-BOEH
2. Name of Authorisation Holder	:	Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe
3. Address(es) of Site(s)	:	Akron utca 1., CP5 Store-house, C08 Cold-chain store-house, Gate 50-56, Budaörs, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Lechner Ödön fasor 10., Budapest, 1095, 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	:	2021-09-15
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: Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe

, Akron utca 1., CP5 Store-house, C08 Cold-chain store-house, Gate 50-56, Budaörs, 2040, 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

3.1.1. Narcotic or psychotropic products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2. Authorised Wholesale Distribution Operation
2.2. Holding
2.2.1. CP5 Room temperature (15-25°C) store-house
2.2.2. C08 Cold chain (2-8°C) store-house

Additional provisions based on national requirements.

Name(s) of responsible person(s)
Dr. Háznagyné Dr. Fekete Rita 29/1977 (pharmacist)
Dr. Jakab Attila 54/2005 (pharmacist)
Dr. Nagy Laura Johanna 68/SE-GYTK-GYO/2017 (pharmacist)

Reason for Withdrawing:

New WDA was given

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

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