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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

Human medicinal products


1. Authorisation Number

:

0949

2. Name of Authorisation Holder

:

Basmeda UAB

(ORG-100045544 / LOC-100075047)

3. Address(es) of Site(s)

:

Ilgoji G. 58, Vilniaus R. Sav., Lindiniskiu K., 14181, Lithuania 




4. Legally registered address of Authorisation Holder

:

Ilgoji G. 58, Vilniaus R. Sav., Lindiniskiu K., 14181

5. Scope of authorisation (complete for each site under 4)

:

ANNEX 1

6. Legal basis of authorisation

:

Art. 77(1) of Directive 2001/83/EC

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2022-08-08

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: Basmeda UAB

(ORG-100045544 / LOC-100075047)

, Ilgoji G. 58, Vilniaus R. Sav., Lindiniskiu K., 14181, Lithuania   



Human medicinal products


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

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  Address of the acivity site: Vilniaus rajono sav., Avižienių sen., Avižienių k., Lubinų g. 12A, LT-14198, Lithuania.

Agreement on logistics serives No. ENT/LPS/2022/04/01  of 1 April 2022 with Uždaroji akcinė bendrovė „ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav., Lithuania (Wholesale distribution authorisation No. 0105). Wholesale distribution operations performed according to the Agreement: reception, holding (warehousing), collection, release and transportation of medicinal products.
/

Veiklos vietos adresas: Vilniaus rajono sav., Avižienių sen., Avižienių k., Lubinų g. 12A, LT-14198.

2022-04-01 logistikos paslaugų sutartis Nr. ENT/LPS/2022/04/01 su Uždarąja akcine bendrove „ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav. (Didmeninio platinimo licencija Nr. 0105). Pagal sutartį vykdomi didmeninio platinimo veiksmai: vaistinių preparatų priėmimas, laikymas (saugojimas), surinkimas, išdavimas, transportavimas.



*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

0949


Page 1





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