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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/004/2025
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 (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-06-03
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 or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Radiopharmaceuticals (including radionuclide kits).

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

Updating the Annex 3 of WDA regarding a change of the Responsible Person.

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.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

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

Union Format for a Wholesale Distribution Authorisation	A027/15/H/004/2025
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