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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	:	A002/15/H/005/2023
2. Name of Authorisation Holder	:	Laboratorios Diater S.A. (ORG-100019003 / LOC-100079884)
3. Address(es) of Site(s)	:	Edificio Logista, Parque Industrial Do Passil 1 A, Alcochete, 2894-002, Portugal

4. Legally registered address of Authorisation Holder	:	Bloco B, Alameda Fernao Lopes 16 Floor 7, Miraflores, Alges, 1495-190
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	:	2023-06-06
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: Laboratorios Diater S.A.

(ORG-100019003 / LOC-100038410)

, Edificio Logista, Parque Industrial Do Passil 1 A, Alcochete, 2894-002, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

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.

Complete Legal Address: Alameda Fernão Lopes, n.º 16 e 16 A (Bloco B), Piso 7, Escritório 3, Miraflores - 1495-190 Algés.

Complete Site Address: Edifício Logísta, Praceta da Fonte Coberta, 153 e 167 - 2894-066 Carnaxide.

*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	A002/15/H/005/2023
	Page 1

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