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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-NEUR
2. Name of Authorisation Holder	:	Neuraxpharm Hungary Kft. (ORG-100046794 / LOC-100077235)
3. Address(es) of Site(s)	:	East Gate Business Park A1 Ep, Akacos Utca 0221/12, Fot, 2151, Hungary

4. Legally registered address of Authorisation Holder	:	Szervita Ter 8, Budapest V, 1052
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	:	2023-09-20
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: Neuraxpharm Hungary Kft.

(ORG-100046794 / LOC-100082435)

, East Gate Business Park A1 Ep, Akacos Utca 0221/12, Fot, 2151, 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

Any restrictions or clarifying remarks (for all users): Authorised Wholesale Distribution Operation

Allopathic medicinal products with storage conditions: "This medicinal product does not require any special storage conditions", "Store below 30°C", "Store below 25°C"

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

D-550-A – D-566-E
D-549-A – D-569-E

*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-NEUR
	Page 1

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