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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

:

0920

2. Name of Authorisation Holder

:

UAB "Nordfarma"

3. Address(es) of Site(s)

:

Verkių g. 31 A, Vilniaus m. sav., Vilniaus m., LT-09108, Lithuania 




4. Legally registered address of Authorisation Holder

:

Verkių g. 31 A, Vilniaus m. sav., Vilniaus m., LT-09108, 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

:

2019-07-17

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 "Nordfarma"

, Verkių g. 31 A, Vilniaus m. sav., Vilniaus m., LT-09108, 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 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 

   3.4. Other products: Herbal, homeopathic, biologic (animal or human origin), cell or gene therapeutic products Augaliniai, homeopatiniai, biologiniai, biotechnologiniai, ląstelių ar genų terapijos preparatai



Any restrictions or clarifying remarks (for all users):  Agreement on service of 17 April 2019 No. ENT/PAS/2019/04/17 with  UAB „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 (storage), and collection of medicinal products.

2019-04-17  paslaugos sutartis Nr. ENT/PAS/2019/04/17 su UAB „ENTAFARMA", Klonėnų vs. 1, Jauniūnų sen., Širvintų r. sav. (Didmeninio platinimo licencija Nr. 0105). Pagal sutartį atliekami didmeninio platinimo veiksmai : vaistinių preparatų priėmimas, laikymas (saugojimas) ir surinkimas.



*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

0920


Page 1





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