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Information Messages
  • The WDA has been withdrawn, withdrawn date is: 2026-10-15
  • RTF Template


    National Authority Of Medicines And Health Products

    UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

    Human medicinal products


    1. Authorisation Number

    :

    A023/21/H/003/2024

    2. Name of Authorisation Holder

    :

    Nippon Gases Portugal Unipessoal Lda.

    (ORG-100000459 / LOC-100007343)

    3. Address(es) of Site(s)

    :

    Rua Do Espido S N, Maia, 4470-177, Portugal 

    Rua Real Fabrica De Atanados 1, Vila Franca De Xira, 2600-242, Portugal 

    Estrada Nacional 125 Sitio Dos Virgilios, Salgados CP60Z, Faro, 8005-540, Portugal 

    Lote 105, Zona Industrial, Constantim, Constantim Vrl, 5000-082, Portugal 

    Rua D Lote 89, Parque Industrial Castelo Branco, Castelo Branco, 6000-790, Portugal 




    4. Legally registered address of Authorisation Holder

    :

    Rua Do Espido S N, Maia, 4470-177

    5. Scope of authorisation

    :

    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 wholesale distribution authorisation

    :

    Confidential, Confidential

    8. Signature

    :


    9. Date

    :

    2024-01-29

    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: Nippon Gases Portugal Unipessoal Lda.

    (ORG-100000459 / LOC-100007343)

    , Rua Do Espido S N, Maia, 4470-177, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Any restrictions or clarifying remarks (for all users):  WDA scope activity - Wholesale Distributor.

    This Wholesale Distribution Authorisation does not cover the supply of medicines under the scope of article 2 of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015.

    Updating of the Authorised Sites regarding the inclusion of a new Site.


    Name and address of the site: Nippon Gases Portugal Unipessoal Lda.

    (ORG-100000459 / LOC-100003127)

    , Rua Real Fabrica De Atanados 1, Vila Franca De Xira, 2600-242, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Any restrictions or clarifying remarks (for all users):  WDA scope activity - Wholesale Distributor.

    This Wholesale Distribution Authorisation does not cover the supply of medicines under the scope of article 2 of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015.

    Updating of the Authorised Sites regarding the inclusion of a new Site.


    Name and address of the site: Nippon Gases Portugal Unipessoal Lda.

    (ORG-100000459 / LOC-100074081)

    , Estrada Nacional 125 Sitio Dos Virgilios, Salgados CP60Z, Faro, 8005-540, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Any restrictions or clarifying remarks (for all users):  WDA scope activity - Wholesale Distributor.

    This Wholesale Distribution Authorisation does not cover the supply of medicines under the scope of article 2 of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015.

    Updating of the Authorised Sites regarding the inclusion of a new Site.


    Name and address of the site: Nippon Gases Portugal Unipessoal Lda.

    (ORG-100000459 / LOC-100076270)

    , Lote 105, Zona Industrial, Constantim, Constantim Vrl, 5000-082, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Any restrictions or clarifying remarks (for all users):  WDA scope activity - Wholesale Distributor.

    This Wholesale Distribution Authorisation does not cover the supply of medicines under the scope of article 2 of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015.


    Name and address of the site: Nippon Gases Portugal Unipessoal Lda.

    (ORG-100000459 / LOC-100074080)

    , Rua D Lote 89, Parque Industrial Castelo Branco, Castelo Branco, 6000-790, Portugal   



    Human medicinal products


    1. MEDICINAL PRODUCTS

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


    2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

       2.1. Procurement 

       2.2. Holding 

       2.3. Supply 


    3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

       3.2. Medicinal gases 




    Any restrictions or clarifying remarks (for all users):  WDA scope activity - Wholesale Distributor.

    This Wholesale Distribution Authorisation does not cover the supply of medicines under the scope of article 2 of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015.








    Reason for Withdrawing:

    Updating WDA Header regarding a change in the legal name of the Authorisation Holder.








    Union Format for a Wholesale Distribution Authorisation

    A023/21/H/003/2024


    Page 1





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