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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-ASTR
2. Name of Authorisation Holder	:	ASTROMEDIC Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
3. Address(es) of Site(s)	:	Gorcsev Ivan Utca 5, Gyal, 2360, Hungary

4. Legally registered address of Authorisation Holder	:	Budai út 49-51. ép. 8. emelet 2., Székesfehérvár, 8000
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	:	2024-02-12
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: Astromedic Kft.

(ORG-100021915 / LOC-100086785)

, Gorcsev Ivan Utca 5, Gyal, 2360, 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

Any restrictions or clarifying remarks (for all users): Any restriction or clarifying remarks related to the scope of these wholesaling operations.
Authorised Wholesale Distribution Operation

2.2.1 Holding

Room temperature (15-25°C) store-house storage locations:

from 16ND0102 to 16ND0107 from 16ND0202 to 16ND0207
from 16ND0302 to 16ND0307 from 16ND0402 to 16ND0407
from 16ND0502 to 16ND0507 from 16ND0602 to 16ND0607
from 16ND0702 to 16ND0707 from 16ND0802 to 16ND0807
from 16ND0902 to 16ND0907

Additional provisions based on national requirements:

Name(s) of responsible person(s): No of diplome:

Dr. Szabó Mihály, 108/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-ASTR
	Page 1

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