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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-09-09

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A028/14/H/003/2022
2. Name of Authorisation Holder	:	Bluemed Unipessoal Lda. (ORG-100000195 / LOC-100000269)
3. Address(es) of Site(s)	:	Rua Do Rio 32, Nogueira, Maia, 4475-493, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Poeta Adriano Correia De Oliveira 233, Fanzeres, 4510-698
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	:	2022-12-03
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: Bluemed Unipessoal Lda.

(ORG-100000195 / LOC-100076861)

, Rua Do Rio 32, Nogueira, Maia, 4475-493, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

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)

3.2. Medicinal gases

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).

3.2 Medicinal gases – They aren't stored in the facilities of this Wholesale distribuitor; they go directly from the manufacturer to the Wholesale distribuitor customers.

Reason for Withdrawing:

Updating WDA, regarding a renewal of the latest Inspection Date of the Certificate of GDP Compliance and an updating of the Annex 1, due to the withdrawal of the reference to radiopharmaceuticals products and medicinal gases.

Union Format for a Wholesale Distribution Authorisation	A028/14/H/003/2022
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