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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-06-05

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A027/15/H/003/2023
2. Name of Authorisation Holder	:	Iberlab Solucoes Para Laboratorios Lda. (ORG-100020097 / LOC-100057259)
3. Address(es) of Site(s)	:	Rua Dos Tractores N 647, Jardia, Alto Estanqueiro-Jardia, 2870-607, PORTUGAL

4. Legally registered address of Authorisation Holder	:	Praceta Da Castanheira 78, Maia, 4475-019
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	:	2023-10-17
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: Iberlab Solucoes Para Laboratorios Lda.

(ORG-100020097 / LOC-100065663)

, Rua Dos Tractores N 647, Jardia, Alto Estanqueiro-Jardia, 2870-607, 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)

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.

Complete Site Address: Rua dos Tractores, n.º 647, Terminal 1 e 4, Alto do Estanqueiro-Jardia -
2870-607 Montijo.

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

Reason for Withdrawing:

Withdraw, due to an updating of the Annex 3 of WDA regarding a change of the Responsible Person.

Union Format for a Wholesale Distribution Authorisation	A027/15/H/003/2023
	Page 1

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