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RTF Template

National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	OGYÉI/14150-4/2016
2. Name of Authorisation Holder	:	UCB Magyarország Kereskedelmi Kft.
3. Address(es) of Site(s)	:	Árpád fejedelem útja 26-28., Budapest, 1023, Hungary

4. Legally registered address of Authorisation Holder	:	Árpád fejedelem útja 26-28., Budapest, 1023, 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	:	2016-08-22
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: UCB Magyarország Gyógyszerforgalmazó Zrt.

, Árpád fejedelem útja 26-28., Budapest, 1023, 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

2.4. Export

2.5. Other activities(s): without carrying out storage activities

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Additional provisions based on national requirements:

Responsible person is: diploma No is:
Dr. Radeczky Géza Zoltán oklevél száma 65/1982 (gyógyszerész)

*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/14150-4/2016
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