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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	:	A004/16/H/004/2025
2. Name of Authorisation Holder	:	Sdsb Farmaceutica Lda. (ORG-100017763 / LOC-100082750)
3. Address(es) of Site(s)	:	Bloco C-F9 Penedo Park Centro Empresarial De Talaide, Estrada Octavio Pato, Sao Domingos De Rana, 2785-723, Portugal

4. Legally registered address of Authorisation Holder	:	Bloco C-F9 Penedo Park Centro Empresarial De Talaide, Estrada Octavio Pato, Sao Domingos De Rana, 2785-723, 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	:	2025-01-10
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: Sdsb Farmaceutica Lda.

(ORG-100017763 / LOC-100082750)

, Bloco C-F9 Penedo Park Centro Empresarial De Talaide, Estrada Octavio Pato, Sao Domingos De Rana, 2785-723, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

3.1. 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 human blood or plasma; immunological; radiopharmaceuticals.

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

Updating of the Annex 1 of WDA.

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

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

Union Format for a Wholesale Distribution Authorisation	A004/16/H/004/2025
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