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RTF Template


National Authority of Medicines and Health Products, I.P.

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

A034/16/H/005/2022

2. Name of Authorisation Holder

:

Sdg Pharma Lda.

(ORG-100037049 / LOC-100058558)

3. Address(es) of Site(s)

:

Rua Quinta Das Palmeiras 31 A, Oeiras, 2780-149, Portugal 




4. Legally registered address of Authorisation Holder

:

Rua Quinta Das Palmeiras 31 A, Oeiras, 2780-149

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

:

2022-01-17

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: Sdg Pharma Lda.

(ORG-100037049 / LOC-100058558)

, Rua Quinta Das Palmeiras 31 A, Oeiras, 2780-149, 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 

   2.4. Export 



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

Updating of the Annex 3 regarding a change of the Responsible Person.



*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

A034/16/H/005/2022


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