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RTF Template

National Authority of Medicines and Health Products, I.P.

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	A029/20/H/002/2021
2. Name of Authorisation Holder	:	Leiruz Med., Indústria Química e Farmacêutica, Lda.
3. Address(es) of Site(s)	:	Rua dos Tractores, n.º 647, Terminal 1 e 4, Alto do Estanqueiro - Jardia, Montijo, 2870-607 Montijo, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Francisco Costa, n.º 15, 1.º Esquerdo, Sintra, 2635-309 Rio de Mouro, Portugal
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-09-15
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: Leiruz Med., Indústria Química e Farmacêutica, Lda.

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

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Immunomodulators, Cytostatic and Biological medicinal products.

Any restrictions or clarifying remarks (for all users): National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August.

WDA scope activity - Wholesale Distributor.

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

The Authorisation number A029/20/H/002/2021 replaces the previous one with the Authorisation number A029/20/H/001/2020, of 2020-12-29.

*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	A029/20/H/002/2021
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