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RTF Template


National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

A008/03/H/003/2025

2. Name of Authorisation Holder

:

Vipfarma Logistica Farmaceutica Lda.

(ORG-100037435 / LOC-100059116)

3. Address(es) of Site(s)

:

Rua Das Industrias 18, Venda Do Pinheiro, 2665-628, Portugal 




4. Legally registered address of Authorisation Holder

:

Rua Das Industrias 18, Venda Do Pinheiro, 2665-628, Portugal

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
National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.

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

:

Confidential, Confidential

8. Signature

:


9. Date

:

2025-02-21

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: Vipfarma Logistica Farmaceutica Lda.

(ORG-100037435 / LOC-100059116)

, Rua Das Industrias 18, Venda Do Pinheiro, 2665-628, Portugal   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

   3.3. Other products: (please specify here or make a reference to Annex 5) Derived from blood; Immunological and Radiopharmaceuticals.




Any restrictions or clarifying remarks (for all users):  WDA scope activity - 3 PL (Third Party Logistics Providers).

Complete scope of WDA for other category of medicinal products: cytostatic; biological; Immunomodulators and investigational medicinal products.



*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

**Without prejudice to further authorisations as may be required according to national legislation.













Union Format for a Wholesale Distribution Authorisation

A008/03/H/003/2025


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