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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-MAGI
2. Name of Authorisation Holder	:	Magilab Kft. (ORG-100034433 / LOC-100060718)
3. Address(es) of Site(s)	:	Bogancsvirag Utca 13-15, Budapest X, 1106, Hungary

4. Legally registered address of Authorisation Holder	:	Kiraly Utca 12, Budapest VI, 1061
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	:	2025-07-23
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: Magilab Kft.

(ORG-100034433 / LOC-100054559)

, Bogancsvirag Utca 13-15, Budapest X, 1106, 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) 3.3.1 Materials for preparation of „magistral formula" (human medicinal products) (2-8°C)

Any restrictions or clarifying remarks (for all users): Any restrictions or clarifying remarks (for all users):
2. Authorised Wholesale Distribution Operation
2.2 Holding
2.2.1 Cold chain (2-8°C) store-house number 10
2.2.3 Non controlled area

3. Other permitted medicinal products with additional special requirements
3.3.1 Materials for preparation of „magistral formula" (human medicinal products) (2-8°C)
3.3.2 Herbal drugs

Additional provisions based on national requirements.

Name(s) of responsible person(s) diploma No is:
Dr. Kőmíves Zsuzsanna 2-15/2002 DEOEC GYTI (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-MAGI
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