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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-07-16

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A009/21/H/002/2024
2. Name of Authorisation Holder	:	Xpharma Lda. (ORG-100037452 / LOC-100059140)
3. Address(es) of Site(s)	:	Estrada Da Quinta 148 148a, Manique, Alcabideche, 2645-436, Portugal

4. Legally registered address of Authorisation Holder	:	Avenida Das Robineas 10, Rinchoa, Rio De Mouro, 2635-545
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	:	2024-04-10
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: Xpharma Lda.

(ORG-100037452 / LOC-100062811)

, Estrada Da Quinta 148 148a, Manique, Alcabideche, 2645-436, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Cytotoxic medicinal products.

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

Updating of the Annex 1 regarding the inclusion of the Cytotoxic Medicinal Products.

Reason for Withdrawing:

Updating of the Annex 1 regarding the inclusion of the 1.3. and the reference to Narcotic or Psychotropic products.

Union Format for a Wholesale Distribution Authorisation	A009/21/H/002/2024
	Page 1

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