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RTF Template

National Centre For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-MERC
2. Name of Authorisation Holder	:	Merck Kft. (ORG-100003696 / LOC-100096270)
3. Address(es) of Site(s)	:	Vasut Utca 11, Budaors, Pest, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Dombovari Ut 25, Budapest XI, 1117
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	:	2025-06-11
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: Merck Kft.

(ORG-100003696 / LOC-100096269)

, Vasut Utca 11, Budaors, Pest, 2040, Hungary

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration 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

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): 2. Authorised Wholesale Distribution Operation
2.2. Holding
2.2.1. Room temperature (15-25°C) storage locations:
from R3:T=ZG01 to A/0-ZG88-G/0
from ZH01-A/0 to ZH16-G/0
NA storage locations:
from R3:T=WZ30-A/0 to R3:T=WZ36-B/0

2.2.2. Cold chain (2-8°C) storehouse locations:
from R3:H=UA17-A/0 to R3:H=UA24-G/0

Additional provisions based on national requirements.

Name(s) of responsible person(s) diploma No is:
Dr. Jakab Mihály 11-20/2011 (pharmacist)

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

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

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