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RTF Template


State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

0592

2. Name of Authorisation Holder

:

UAB "GDP sprendimai"

3. Address(es) of Site(s)

:

Terminalo g. 6, Kuprioniškių k., Nemėžio sen., Vilniaus r. sav., LT-13279, Lithuania 




4. Legally registered address of Authorisation Holder

:

Konstitucijos pr. 9-123, Vilnius, LT-09308, Lithuania

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

:

2006-01-19

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: UAB "GDP sprendimai"

, Terminalo g. 6, Kuprioniškių k., Nemėžio sen., Vilniaus r. sav., LT-13279, Lithuania   




1. MEDICINAL PRODUCTS

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

   1.3. without a Marketing Authorisation in the EEA and intended for exportation


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 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 

   3.4. Other products: Traditional herbal medicinal products Tradiciniai augaliniai vaistiniai preparatai





*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

0592


Page 1





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