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RTF Template


National Institute of Pharmacy and Nutrition

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

HU-D-VDIS

2. Name of Authorisation Holder

:

"VIRIDIS-PHARMA" Gyógyszer-nagykereskedelmi, Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság

3. Address(es) of Site(s)

:

Béke út 15-17., Bekecs, 3903, Hungary 

Keleti Márton út 12. - 2019 hrsz., MASPED Észak Pesti Logisztika Központ „B" terminál, (MÉPLK „B"), 1-es csarnokhoz tartozó „RÓNA" raktárrész és iroda (142m2), Fót, 2151, Hungary 




4. Legally registered address of Authorisation Holder

:

Béke út 15-17., Bekecs, 3903, Hungary

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

:

2020-09-10

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: "VIRIDIS-PHARMA" Gyógyszer-nagykereskedelmi, Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság

, Béke út 15-17., Bekecs, 3903, Hungary   




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 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


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: see in restriction part




Any restrictions or clarifying remarks (for all users):  2. Authorised Wholesale Distribution Operation
2.2 Holding:
2.2.1 Room temperature (15-25°C) store-house
2.2.2 Cool chain (8-15°C) store-house
2.2.3 Cold chain (2-8°C) store-house

3. Medicinal products with additional requirements
3.4 Other products:
3.4.1 Homeopathic medicinal products

Additional provisions based on national requirements.
Name(s) of responsible person(s)                                
Dr. Nyitrai Andrea                                                         79/2003 (pharmacist)


Name and address of the site: "VIRIDIS-PHARMA" Gyógyszer-nagykereskedelmi, Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság

, Keleti Márton út 12. - 2019 hrsz., MASPED Észak Pesti Logisztika Központ „B" terminál, (MÉPLK „B"), 1-es csarnokhoz tartozó „RÓNA" raktárrész és iroda (142m2), Fót, 2151, Hungary   




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 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


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: see in restriction part




Any restrictions or clarifying remarks (for all users):  2. Authorised Wholesale Distribution Operation
2.2 Holding:
2.2.1 Room temperature (15-25°C) store-house
2.2.2 Cool chain (8-15°C) store-house
2.2.3 Cold chain (2-8°C) store-house

3. Medicinal products with additional requirements
3.4 Other products:
3.4.1 Homeopathic medicinal products

Additional provisions based on national requirements.
Name(s) of responsible person(s)                                
Dr. Nyitrai Andrea                                                  79/2003 (pharmacist)



*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

HU-D-VDIS


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