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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-12-11

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A069/06/H/003/2023
2. Name of Authorisation Holder	:	Isotopos E Derivados (Isoder) S.A. (ORG-100036416 / LOC-100082777)
3. Address(es) of Site(s)	:	Edifício Decopharma, Estrada Do Pau Queimado Afonseiro, Montijo, 2870-100, PORTUGAL

4. Legally registered address of Authorisation Holder	:	Rua Doutor Antonio Loureiro Borges N 9 5 Piso, Alges, 1495-131
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	:	2023-10-30
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: Isotopos E Derivados (Isoder) S.A.

(ORG-100036416 / LOC-100087229)

, Edifício Decopharma, Estrada Do Pau Queimado Afonseiro, Montijo, 2870-100, PORTUGAL

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

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

This Wholesale Distribution Authorisation does not cover the supply of medicines under the scope of article 2 of the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015.

Updating of the WDA Header regarding a change in the legal address of the Authorisation Holder.
Updating of the WDA scope activity.
Transfer of Facilities.

Reason for Withdrawing:

Updating of the WDA Header regarding a change in the legal address of the Authorisation Holder.

Union Format for a Wholesale Distribution Authorisation	A069/06/H/003/2023
	Page 1

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