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RTF Template

State Institute for Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	sukls142858/2013
2. Name of Authorisation Holder	:	Merck Sharp & Dohme s.r.o.
3. Address(es) of Site(s)	:	warehouse is in PHOENIX lékárenský velkoobchod, a.s., K pérovně 945/7, Praha 10 - Hostivař, 102 00, Czech Republic warehouse is in PHOENIX lékárenský velkoobchod, a.s.,Vinohradská 72, Brno, 618 00, Czech Republic warehouse is in PHOENIX lékárenský velkoobchod, a.s., U Seřadiště 198, Plzeň, 326 00, Czech Republic warehouse is in PHOENIX lékárenský velkoobchod, a.s., Třeboňská 229, Ševětín, 376 63, Czech Republic warehouse is in PHOENIX lékárenský velkoobchod, a.s., Fibichova 143/II, Vysoké Mýto, 566 17, Czech Republic warehouse is in PHOENIX lékárenský velkoobchod, a.s., Stará cesta 8, Ostrava - Hrušov, 711 00, Czech Republic

4. Legally registered address of Authorisation Holder	:	Evropská 2588/33a, Praha 6 - Dejvice, 160 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	:	2013-09-02
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: Merck Sharp & Dohme s.r.o.

, warehouse is in PHOENIX lékárenský velkoobchod, a.s., K pérovně 945/7, Praha 10 - Hostivař, 102 00, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: Merck Sharp & Dohme s.r.o.

, warehouse is in PHOENIX lékárenský velkoobchod, a.s.,Vinohradská 72, Brno, 618 00, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: Merck Sharp & Dohme s.r.o.

, warehouse is in PHOENIX lékárenský velkoobchod, a.s., U Seřadiště 198, Plzeň, 326 00, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: Merck Sharp & Dohme s.r.o.

, warehouse is in PHOENIX lékárenský velkoobchod, a.s., Třeboňská 229, Ševětín, 376 63, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: Merck Sharp & Dohme s.r.o.

, warehouse is in PHOENIX lékárenský velkoobchod, a.s., Fibichova 143/II, Vysoké Mýto, 566 17, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: Merck Sharp & Dohme s.r.o.

, warehouse is in PHOENIX lékárenský velkoobchod, a.s., Stará cesta 8, Ostrava - Hrušov, 711 00, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

*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	sukls142858/2013
	Page 1

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