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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-11-28

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A041/12/H/004/2025
2. Name of Authorisation Holder	:	Ratiopharm Comercio E Industria De Produtos Farmaceuticos Lda. (ORG-100001113 / LOC-100004619)
3. Address(es) of Site(s)	:	Terminal 1, Rua Dos Tractores N 647, Jardia, Alto Estanqueiro-Jardia, 2870-607, Portugal

4. Legally registered address of Authorisation Holder	:	Edificio 5 A, Lagoas Park 2, Porto Salvo, 2740-245
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	:	2025-04-21
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: Ratiopharm Comercio E Industria De Produtos Farmaceuticos Lda.

(ORG-100001113 / LOC-100065311)

, Terminal 1, Rua Dos Tractores N 647, Jardia, Alto Estanqueiro-Jardia, 2870-607, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

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) Biological medicinal products.

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

Updating WDA, regarding a a renewal of the latest Inspection Date of the Certificate of GDP Compliance.

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

Reason for Withdrawing:

Updating WDA with the complet site address.

Union Format for a Wholesale Distribution Authorisation	A041/12/H/004/2025
	Page 1

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