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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	HU-D-IZOT
2. Name of Authorisation Holder	:	Izotóp Intézet Kutató, Fejlesztő, Termelő és Szolgáltató Korlátolt Felelősségű Társaság
3. Address(es) of Site(s)	:	Konkoly-Thege M. út 29-33., Budapest, 1121, Hungary

4. Legally registered address of Authorisation Holder	:	Konkoly-Thege M. út 29-33., Budapest, 1121, 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	:	2021-10-12
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: Izotóp Intézet Kutató, Fejlesztő, Termelő és Szolgáltató Korlátolt Felelősségű Társaság

, Konkoly-Thege M. út 29-33., Budapest, 1121, 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

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2. Authorised Wholesale Distribution Operation
2.2 Holding
2.2.1 Room temperature (15-25°C) store-house
2.2.2 Cold chain (2-8°C) store-house
2.2.3 Medicinal products should be stored at ≤ -18°C

Additional provisions based on national requirements.

Name(s) of Responsible Person(s)
Dr. Korpás Gábor                              47/1980 (pharmacist)
Dr. Balogh Beáta                                 8/2004 (pharmacist)
Dr. Perjéssy-Végh Krisztina Emese      94/2009 (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-IZOT
	Page 1

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