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RTF Template

National Centre For Public Health And Pharmacy

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	HU-D-MEGO
2. Name of Authorisation Holder	:	Medigo Pharma Zrt. (ORG-100038669 / LOC-100091824)
3. Address(es) of Site(s)	:	Erdomenti Ut 3, Budapest XV, 1152, Hungary

4. Legally registered address of Authorisation Holder	:	Bercsenyi Utca 21, Kerulet, Budapest XI, 1117
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	:	2025-06-02
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: Medigo Pharma Zrt.

(ORG-100038669 / LOC-100096754)

, Erdomenti Ut 3, Budapest XV, 1152, Hungary

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Transport

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Homeopathic medicinal products

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

2.2 Holding:
2.2.1 15-25°C) store-house
I-A-01-01-01, I-A-10-05-03, I-B-01-01, I-R-01-09, E-A-01-01, E-R-01-12

2.2.2 Cold chain store-chamber (temperature: 2°C - 8°C):
HK 03 hűtőkamra: I-H-01-01-01, I-H-03-05-03, E-H-01-01-01, E-H-01-05-03

3. Other permitted medicinal products with additional special requirements /
3.4 Other products:
Homeopathic medicinal products

Additional provisions based on national requirements
Name(s) of responsible person(s)
Dr. Szénási Zsolt (pharmacist)
Dr. Rozmanicz Gergő (pharmacist)

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

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

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