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RTF Template


State Institute for Drug Control

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

FV-674/18

2. Name of Authorisation Holder

:

LIEK s. r. o.

3. Address(es) of Site(s)

:

Opatovská cesta 4, Bojnice, 97201, Slovakia 




4. Legally registered address of Authorisation Holder

:

Hviezdoslavova 19, Senec, 90301, Slovakia

5. Scope of authorisation

:

ANNEX 1

6. Legal basis of authorisation

:


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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2018-03-19

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: LIEK s. r. o.

, Opatovská cesta 4, Bojnice, 97201, Slovakia   




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 
















Union Format for a Wholesale Distribution Authorisation

FV-674/18


Page 1





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