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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-11-27

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A018/24/H/001/2024
2. Name of Authorisation Holder	:	Cardiva Portugal Unipessoal Lda. (ORG-100052749 / LOC-100092947)
3. Address(es) of Site(s)	:	Rua Quinta Do Pinheiro 5, Alverca Do Ribatejo, 2615-184, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Calouste Gulbenkian Lote 1 Nº 52 E 4, Porto, 4050-144, Portugal
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	:	2024-11-06
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: Cardiva Portugal Unipessoal Lda.

(ORG-100052749 / LOC-100093893)

, 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)

1.3. 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) Medicinal products derived from blood; Immunological medicinal products; Radiopharmaceuticals.

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

Complete Site Address: Quinta do Pinheiro, n.º 5 - 2615-184 Alverca do Ribatejo.

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

Reason for Withdrawing:

Updating WDA due to a change in the legally registered address of Authorisation Holder.

Union Format for a Wholesale Distribution Authorisation	A018/24/H/001/2024
	Page 1

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