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RTF Template

State Institute for Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	sukls138331/2015
2. Name of Authorisation Holder	:	OMEGA PHARMA a.s.
3. Address(es) of Site(s)	:	warehouse is in Alliance Healthcare s.r.o., Evropská 871 a 872, Modřice, 664 42, Czech Republic warehouse is in Alliance Healthcare s.r.o., Podle Trati 624/7, Praha 10 - Malešice, 108 00, Czech Republic

4. Legally registered address of Authorisation Holder	:	Drážní 253/7, Brno - Slatina, 627 00, Czech Republic
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	:	2015-08-24
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: OMEGA PHARMA a.s.

, warehouse is in Alliance Healthcare s.r.o., Evropská 871 a 872, Modřice, 664 42, Czech Republic

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

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)