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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-NATU
2. Name of Authorisation Holder	:	NATURLAND Magyarország Termelő és Kereskedelmi Korlátolt Felelősségű Társaság (Naturland Magyarország Kft.)/Naturland Magyarország Ltd.
3. Address(es) of Site(s)	:	Csillagvirág u. 8., Budapest, 1106, Hungary

4. Legally registered address of Authorisation Holder	:	Csillagvirág u. 8., Budapest, 1106
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	:	2025-06-06
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: NATURLAND Magyarország Termelő és Kereskedelmi Korlátolt Felelősségű Társaság/ Naturland Magyarország Ltd.

, Csillagvirág u. 8., Budapest, 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

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) Temperatures between 8 to 15 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Materials for preparation of „magistral formula", Herbal and animal derived drugs

Any restrictions or clarifying remarks (for all users): 2 Authorised Wholesale Distribution Operation
2.2 Holding
2.2.1 Drugs with special storage conditions 8 -15°C

3 Other permitted medicinal products with additional special requirements
3.4 Other products
3.4.1 Materials for preparation of „magistral formula" (human medicinal products)
3.4.2 Herbal and animal derived drugs

Additional provisions based on national requirement.

Name(s) of responsible person(s)
Dr. Vásárhelyi Szilvia 98/SE-GYTK-GYO/2015 (pharmacist)
Dr. Pataki Éva 94/SE-GYTK-GYO/2017 (pharmacist)
Dr. Kürtösi Balázs GYTK-00025/2023/OKL (pharmacist)

Remark: The Wholesale Distribution Authorisation applies only to medicinal products which Marketing Authorisation holder and production site is Naturland Magyarország Ltd.

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

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	HU-D-NATU
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