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RTF Template


State Institute For Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

sukls289589/2026

2. Name of Authorisation Holder

:

Stada Pharma CZ s.r.o.

(ORG-100000859 / LOC-100009819)

3. Address(es) of Site(s)

:

Vlastimila Pecha 1278/7, Cernovice, Brno, 627 00, Czechia 

Nova Tovarni 1940, Cesky Tesin, 737 01, Czechia 




4. Legally registered address of Authorisation Holder

:

Siemensova 2717/4, Stodulky, Prague, 155 00

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2026-10-13

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: Stada Pharma CZ s.r.o.

(ORG-100000859 / LOC-100064836)

, Vlastimila Pecha 1278/7, Cernovice, Brno, 627 00, Czechia   



Human medicinal products


1. MEDICINAL PRODUCTS

   1.1. with a Marketing Authorisation or registration 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

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 




Name and address of the site: Stada Pharma CZ s.r.o.

(ORG-100000859 / LOC-100064834)

, Nova Tovarni 1940, Cesky Tesin, 737 01, Czechia   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 
















Union Format for a Wholesale Distribution Authorisation

sukls289589/2026


Page 1





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