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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-FRME
2. Name of Authorisation Holder	:	FMC Magyarorszag Kft. (ORG-100000549 / LOC-100060668)
3. Address(es) of Site(s)	:	East Gate Business Park Building C, Staircase 3 Unit 6, Fot, 2151, Hungary

4. Legally registered address of Authorisation Holder	:	Arpad Fejedelem Utja 26-28, Budapest II, 1023
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	:	2024-03-19
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: Fresenius Medical Care Magyarorszag Kft.

(ORG-100000549 / LOC-100062795)

, East Gate Business Park Building C, Staircase 3 Unit 6, 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

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Dialysing solutions (s.c. CAPD solutions) applying for continuous ambulant peritoneal dialysis.

Any restrictions or clarifying remarks (for all users): 2. Authorised Wholesale Distribution Operation
2.2. Holding:
2.2.1. Room temperature store-house (15-25°C)
2.2.2. Refrigerator HUTO 1 for Cold chain storage (2-8°C)
2.2.3. Refrigerator HUTO 2 for Cold chain storage (2-8°C)
3. Medicinal products with additional requirements
3.4 Other products:
3.4.1. Dialysing solutions (s.c. CAPD solutions) applying for continuous ambulant peritoneal dialysis.
Additional provisions based on national requirements

Name(s) of responsible person(s) Diploma No.:
Dr. Janicsák Gábor 50/1991 (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-FRME
	Page 1

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