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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-10-12

RTF Template

National Public Health And Pharmaceutical Centre

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-OXIM
2. Name of Authorisation Holder	:	Oximio Hungary Kft. (ORG-100038546 / LOC-100060575)
3. Address(es) of Site(s)	:	Topark Utca 1/a, Torokbalint, 2045, Hungary

4. Legally registered address of Authorisation Holder	:	Topark Utca 1/a, Torokbalint, 2045
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-05-15
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: Oximio Hungary Kft.

(ORG-100038546 / LOC-100060575)

, Topark Utca 1/a, Torokbalint, 2045, 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

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Authorized Wholesale Distribution Operation
2.2 Holding
2.2.1 Room temperature (15-25°C) store-house
2.2.2 Cold chain (2-8°C) store-house
2.2.3 Frozen storage (-15 – - 25°C)
2.2.4 Ultra frozen storage (-70 ± 10°C)

Additional provisions based on national requirements

Name(s) of responsible person(s) Diploma No.
Dr. Takács Márta 96/1984 (Pharmacist)

Reason for Withdrawing:

new one issued

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

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