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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

:

0606

2. Name of Authorisation Holder

:

UAB "Lex ano"

3. Address(es) of Site(s)

:

Vingrių g. 17A, Vilniaus m. sav.,  Vilniaus m., LT-01141, Lithuania 




4. Legally registered address of Authorisation Holder

:

Naugarduko g. 3, Vilniaus m. sav., Vilniaus m., LT-03231, Lithuania

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

:

2017-06-13

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: UAB "Lex ano"

, Vingrių g. 17A, Vilniaus m. sav.,  Vilniaus m., LT-01141, 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 

   2.5. Other activities(s): Parallel import and distributionLygiagretus importas ir platinimas


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     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: Herbal m p. / Homeopathic m. p. / Biological m. p. / cell or gene therapeutics m.p. Augaliniai / Homeopatiniai / Biologiniai preparatai / ląstelių ar genų terapijos preparatai




Any restrictions or clarifying remarks (for all users):  Agreement of 14 April 2006 No. 2006 04 14-1 with  UAB "Alaja" ir Ko, A.Mickevičiaus g. 32A, Kėdainių m., Kėdainių r. sav., Lithuania (Wholesale Distribution Authorisation No.0106). Wholesale distribution operations performed according to the agreement: reception of medicinal products, holding (storage), collection and transportation.

2006-04-14 sutartis  Nr. 2006 04 14-1 su UAB "Alaja" ir Ko, A.Mickevičiaus g. 32A, Kėdainių m., Kėdainių r. sav., (Didmeninio platinimo licencija Nr. 0106). Pagal sutartį vykdomi didmeninio platinimo veiksmai: vaistinių preparatų priėmimas, laikymas (saugojimas), surinkimas ir  transportavimas















Union Format for a Wholesale Distribution Authorisation

0606


Page 1





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