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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-02-06

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A017/19/H/004/2024
2. Name of Authorisation Holder	:	Ocp Portugal Produtos Farmaceuticos S.A. (ORG-100019830 / LOC-100028573)
3. Address(es) of Site(s)	:	Zona Industrial Constantim 224, Vila Real, 5000-082, Portugal Rua Coronel Edgar Pereira Da Costa Cardoso 3e 3a, Vila Franca De Xira, 2615-382, Portugal Zona Industrial De Cotoas, Torres Novas, 2350-484, Portugal Crestins, Rua Do Barreiro 179, Moreira, 4470-573, Portugal Estrada Do Aerodromo 45, Viseu, 3515-342, Portugal Lote 1d Ribeiro Meirinho, Loteamento Industrial Algarpark, Silves, 8375-071, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Do Barreiro N 235, Crestins - Moreira, 4470-573 MAIA, Portugal
5. Scope of authorisation	:	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 wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-06-23
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: Ocp Portugal Produtos Farmaceuticos S.A.

(ORG-100019830 / LOC-100090203)

, Zona Industrial Constantim 224, Vila Real, 5000-082, 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

3.1.3. 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 and 3 PL (Third Party Logistics Providers).

Transfer of Facilities.

Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

(ORG-100019830 / LOC-100065356)

, Rua Coronel Edgar Pereira Da Costa Cardoso 3e 3a, Vila Franca De Xira, 2615-382, 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

3.1.3. 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 and 3 PL (Third Party Logistics Providers).

Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

(ORG-100019830 / LOC-100065353)

, Zona Industrial De Cotoas, Torres Novas, 2350-484, 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

3.1.3. 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 and 3 PL (Third Party Logistics Providers).

Updating of the Authorised Site regarding the expansion of the Facilities / Address of the Site.

Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

(ORG-100019830 / LOC-100038468)

, Crestins, Rua Do Barreiro 179, Moreira, 4470-573, 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

3.1.3. 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 and 3 PL (Third Party Logistics Providers).

Complete Site Address: Rua do Barreiro, n.º 179, Fração F, G e H, Crestins-Moreira - 4470-573 Maia.

Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

(ORG-100019830 / LOC-100038466)

, Estrada Do Aerodromo 45, Viseu, 3515-342, 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

3.1.3. 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 and 3 PL (Third Party Logistics Providers).

Complete Site Address: Zona Empresarial do Campo, Estrada do Aeródromo, n.º 45 - 3515-342 Viseu.

Name and address of the site: Ocp Portugal Produtos Farmaceuticos S.A.

(ORG-100019830 / LOC-100063923)

, Lote 1d Ribeiro Meirinho, Loteamento Industrial Algarpark, Silves, 8375-071, 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

3.1.3. 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 and 3 PL (Third Party Logistics Providers).

Complete Site Address: Loteamento Industrial Algarpark, Lote 1 D, Ribeiro Meirinho - 8375-071 São Bartolomeu de Messines

Reason for Withdrawing:

Updating the Annex 1 of the WDA regarding a change in the WDA scope activity.

Union Format for a Wholesale Distribution Authorisation	A017/19/H/004/2024
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