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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	:	A016/20/H/004/2024
2. Name of Authorisation Holder	:	Medzediz Unipessoal Lda. (ORG-100018531 / LOC-100058128)
3. Address(es) of Site(s)	:	Lote 3, Estrada Consiglieri Pedroso Nº 80, Armazem A2 Queluz de Baixo, Oeiras, 2730-056 BARCAR, Portugal Lote 1, Lugar de Crasto Zona Industrial II, Penafiel, 4560-657, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Rodrigo Da Fonseca 103 1 Andar, Lisbon, 1070-239
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	:	2024-06-06
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: Medzediz Unipessoal Lda.

(ORG-100018531 / LOC-100064056)

, Lote 3, Estrada Consiglieri Pedroso Nº 80, Armazem A2 Queluz de Baixo, Oeiras, 2730-056 BARCAR, 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

3.1.1. 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)

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

Complete Site Address: Estrada Consiglieri Pedroso, n.º 80, Queluz Park, Lote 3, Armazém A2, Queluz de Baixo - 2730-056 Barcarena

Name and address of the site: Medzediz Unipessoal Lda.

(ORG-100018531 / LOC-100064070)

, Lote 1, Lugar de Crasto Zona Industrial II, Penafiel, 4560-657, 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

3.1.1. 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)

Any restrictions or clarifying remarks (for all users): WDA scope activity - Wholesale Distributor and 3 PL (Third Party Logistics Providers).

*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	A016/20/H/004/2024
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