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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

:

0899

2. Name of Authorisation Holder

:

UAB ''Vitardus"

3. Address(es) of Site(s)

:

Paupio g. 28, Vilniaus m. sav., Vilniaus m., LT-11341, Lithuania 




4. Legally registered address of Authorisation Holder

:

Vito Gerulaičio g. 1-1, Vilniaus m. Vilniaus m. sav., LT-08200, 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

:

2017-03-15

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 "Vitardus"

, Paupio g. 28, Vilniaus m. sav., Vilniaus m., LT-11341, Lithuania   




1. MEDICINAL PRODUCTS

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

   1.2. without a Marketing Authorisation in the EEA and intended for EEA market

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   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):  Agreement on logistics services of  1 September 2016 No. 2016/09/1 with UAB "GDP sprendimai", Terminalo g. 6, Kuprioniškių k., Nemėžio sen., Vilniaus r. sav., Lithuania (Wholesale distribution authorisation No. 0592). Wholesale distribution operations performed according to the agreement: reception, holding (warehousing) of medicinal products, warehousing of non-saleable medicinal products, receipt of orders for supply of medicinal products, issuing of orders for supply of medicinal products, accountancy of medicinal products (goods) and accountancy of movement on the batch level and traceability.

2016-09-01  logistikos paslaugų sutartis Nr. 2016/09/1 su UAB "GDP sprendimai", Terminalo g. 6, Kuprioniškių k., Nemėžio sen., Vilniaus r. sav. (Didmeninio platinimo licencija Nr. 0592). Pagal sutartį vykdomi didmeninio platinimo veiksmai: vaistinių preparatų priėmimas, laikymas (sandėliavimas), netiektinų vaistų sandėliavimas, užsakymų vaistų tiekimui priėmimas, užsakymų vaistų tiekimui išdavimas, vaistų (prekių) apskaita ir judėjimo apskaita serijos lygmenyje ir atsekamumas.



*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

0899


Page 1





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