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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	HU-D-BOIR
2. Name of Authorisation Holder	:	Boiron Hungária Gyógyszernagykereskedelmi Korlátolt Felelősségű Társaság
3. Address(es) of Site(s)	:	Akron u. 1., 9. számú raktár (Camel Park), Budaörs, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Márvány utca 18, Budapest, 1012, Hungary
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-12-01
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: Boiron Hungária Gyógyszernagykereskedelmi Korlátolt Felelősségű Társaság

, Akron u. 1., 9. számú raktár (Camel Park), Budaörs, 2040, Hungary

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

3.4. Other products: see in restriction part

Any restrictions or clarifying remarks (for all users): 1. Medicinal products: Exclusively homeopathic medicinal products

2. Authorised Wholesale Distribution Operation
2.1. Procurement: Exclusively homeopathic medicinal products
2.2. Holding
2.2.1. Room temperature (15-25°C) store-house: Exclusively homeopathic medicinal products
2.3. Supply: Exclusively homeopathic medicinal products
2.4. Export: Exclusively homeopathic medicinal products

3. Medicinal products with additional requirements
3.4. Other product
3.4.1. Homeopathic medicinal products

Additional provisions based on national requirements

Name(s) of Responsible Person(s)         diploma No is:
Dr. Slavovné Dr. Gaál Mária                  25/1983 (pharmacist)
Dr. Kiss Krisztina                                  40/2000. (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-BOIR
	Page 1

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