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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	:	A002/20/H/003/2024
2. Name of Authorisation Holder	:	Alliance Healthcare S.A. (ORG-100009467 / LOC-100074739)
3. Address(es) of Site(s)	:	Caminho Cerro Do Galo No 18, Almancil, Loule, 8135-028, Portugal Quelha Do Barrocal, Castelo Branco, 6000-128, Portugal Avenida Do Termo De Lisboa 32, Forte Da Casa, 2625-443, Portugal Rua Engenheiro Ferreira Dias 738, Porto, 4100-246, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Do Engenheiro Ferreira Dias 728, Porto, 4149-014, Portugal
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	:	2024-10-27
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: Alliance Healthcare S.A.

(ORG-100009467 / LOC-100064098)

, Caminho Cerro Do Galo No 18, Almancil, Loule, 8135-028, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Cytotoxic and immunological medicinal products.

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

Complete Legal Address: Rua Engenheiro Ferreira Dias, n.º 728, 3º Piso Sul - 4149-014 Porto.

Name and address of the site: Alliance Healthcare S.A.

(ORG-100009467 / LOC-100064097)

, Quelha Do Barrocal, Castelo Branco, 6000-128, 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

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Cytotoxic and immunological medicinal products.

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

Updating of the Annex 1 regarding the inclusion of the Immunological Medicinal Products.

Complete Legal Address: Rua Engenheiro Ferreira Dias, n.º 728, 3º Piso Sul - 4149-014 Porto.

Name and address of the site: Alliance Healthcare S.A.

(ORG-100009467 / LOC-100079887)

, Avenida Do Termo De Lisboa 32, Forte Da Casa, 2625-443, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood; immunological and radiopharmaceuticals (including radionucli

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

Complete Legal Address: Rua Engenheiro Ferreira Dias, n.º 728, 3º Piso Sul - 4149-014 Porto.

Name and address of the site: Alliance Healthcare S.A.

(ORG-100009467 / LOC-100017722)

, Rua Engenheiro Ferreira Dias 738, Porto, 4100-246, 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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal products derived from blood; immunological and radiopharmaceuticals (including radionucli

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

Complete Legal Address: Rua Engenheiro Ferreira Dias, n.º 728, 3º Piso Sul - 4149-014 Porto.

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

Union Format for a Wholesale Distribution Authorisation	A002/20/H/003/2024
	Page 1

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