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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	OGYÉI/48637-6/2017
2. Name of Authorisation Holder	:	MEDI-RADIOPHARMA Kft.
3. Address(es) of Site(s)	:	Gyár utca 2., Budaörs, 2040, Hungary

4. Legally registered address of Authorisation Holder	:	Szamos utca 10-12., Érd, 2030, 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	:	2017-11-06
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: MEDI-RADIOPHARMA Kft.

, Gyár utca 2., 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

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Materials for preparation of „magistral formula" (human medicinal products), 2-8°C, 15-25°C

Any restrictions or clarifying remarks (for all users): Room temperature (15-25°C) storage locations: N-02-K-1-4, N-03-K-1-4, N-02-F-1-4, N-03-F-1-4
Cold chain (2-8°C) storage locations: MRN-06-K-1-2, MRN-08-K-1-2, MRN-05-F-1-2, MRN-07-F-1-2
Additional provisions based on national requirements
Name(s) of responsible person(s)
Responsible person :          diploma No.:
Dr. Kósa Hajnalka      13-36/2013 (pharmacist)
Dr. Jánoki Győző        45/1974 (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	OGYÉI/48637-6/2017
	Page 1

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