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RTF Template

National Center For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-CLCP
2. Name of Authorisation Holder	:	CLC Pharma Kft. (ORG-100051306 / LOC-100089867)
3. Address(es) of Site(s)	:	Karolyi Sandor Ut 121, Budapest XV, 1151, Hungary

4. Legally registered address of Authorisation Holder	:	Zsambeki Ut 220/1, Herceghalom, 2053, Hungary
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 Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-07-09
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: CLC Pharma Kft.

(ORG-100051306 / LOC-100089866)

, Karolyi Sandor Ut 121, Budapest XV, 1151, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Any restriction or clarifying remarks related to the scope of these wholesaling operations.
2. Authorised Wholesale Distribution Operation
2.2. Holding:
2.2.1. Room temperature (15-25°C) store-house storage locations:
from H1-01-R1 to H1-20-R7,
from H1-22-R1 to H1-38-R2
from H2-01-R1 to H2-07-R7

separated storage spaces:
from EL-CL-01 to EL-CL-99
from KI-CL-01 to KI-CL-99
from SE-CL-01 to SE-CL-99

2.2.3. Cold chain (2-8°C) store-house storage locations:
from H1-01-C1 to H1-03-C7

separated storage spaces:
from EL-CL-C1 to EL-CL-C9
from KI-CL-C1 to KI-CL-C9
from SE-CL-C1 to SE-CL-C9

Additional provisions based on national requirements
Name of responsible person Number of the diploma
Dr. Rozmanicz Gergő 94/SE-GYTK-GYO-2016 (pharmacist)

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

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