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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-11-05

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A005/25/H/001/2025
2. Name of Authorisation Holder	:	Hovione Farmaciencia S.A. (ORG-100001467 / LOC-100000315)
3. Address(es) of Site(s)	:	Campus Do Lumiar Edificio R, Estrada Do Paco Do Lumiar, Lisbon, 1649-038, Portugal

4. Legally registered address of Authorisation Holder	:	Quinta Sao Pedro, Sete Casas, Loures, 2674-506
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	:	2025-02-16
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: Hovione Farmaciencia S.A.

(ORG-100001467 / LOC-100058864)

, Campus Do Lumiar Edificio R, Estrada Do Paco Do Lumiar, Lisbon, 1649-038, 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

2.2. Holding

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

3.2.2. Other temperatures: (please specify) -20ºC

3.3. Other products: (please specify here or make a reference to Annex 5) Investigational medicinal products.

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

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

Reason for Withdrawing:

Updating of the WDA, due to an inclusion of a new site.

Union Format for a Wholesale Distribution Authorisation	A005/25/H/001/2025
	Page 1

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