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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

:

A003/23/H/002/2025

2. Name of Authorisation Holder

:

Sanina & Sanina Lda.

(ORG-100045433 / LOC-100074898)

3. Address(es) of Site(s)

:

Rua Quinta Do Pinheiro 5, Alverca Do Ribatejo, 2615-184, Portugal 




4. Legally registered address of Authorisation Holder

:

Avenida Da Republica 6 1.º Esq., Lisbon, 1050-191, 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

:

2025-02-05

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: Sanina & Sanina Lda.

(ORG-100045433 / LOC-100095023)

, Rua Quinta Do Pinheiro 5, Alverca Do Ribatejo, 2615-184, 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

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   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) Immunological medicinal products and contrast media for image.




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

Updating of the WDA due to a Transfer of Facilities.



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













Union Format for a Wholesale Distribution Authorisation

A003/23/H/002/2025


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