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RTF Template


State Institute for Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

13463/3/INS/98

2. Name of Authorisation Holder

:

KC SOLID, spol. s r.o.

3. Address(es) of Site(s)

:

Butovická 35, Praha 5, 158 00, Czech Republic 

Alej Svobody 80, Areál FN, Plzeň, 304 60, Czech Republic 




4. Legally registered address of Authorisation Holder

:

ul. Míru 16, Rokycany, 337 01, 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

:

1998-08-27

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: KC SOLID, spol. s r.o.

, Butovická 35, Praha 5, 158 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 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  site was closed 2007-01-04

sklad byl zrušen 4.1.2007


Name and address of the site: KC SOLID, spol. s r.o.

, Alej Svobody 80, Areál FN, Plzeň, 304 60, 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

     3.1.2. Medicinal products derived from blood 

     3.1.4. Radiopharmaceuticals (including radionuclide kits) 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  site was closed  2007-12-20

sklad byl zrušen 20.12.2007



*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

13463/3/INS/98


Page 1





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