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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	HU-D-BIOS
2. Name of Authorisation Holder	:	BIOSAN Egészségügyi Kereskedelmi és Szolgáltató Kft.
3. Address(es) of Site(s)	:	Szentendrei út 89-95., X. számú épület, F7, Budapest, 1033, Hungary

4. Legally registered address of Authorisation Holder	:	Miklós utca 11., Budapest, 1035, 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	:	2020-12-09
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: BIOSAN Egészségügyi Kereskedelmi és Szolgáltató Kft.

, Szentendrei út 89-95., X. számú épület, F7, Budapest, 1033, 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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Any restriction or clarifying remarks related to the scope of these wholesaling operations
Authorised Wholesale Distribution Operation
2.2 Holding:
2.2.1 Room temperature store-house (15-25°C)
2.2.1 Cold chain chamber (2-8°C)

Additional provisions based on national requirements

Name(s) of Responsible Person(s)
Dr. Janáky Judit 60/1967 (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-BIOS
	Page 1

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