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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-05-15

RTF Template

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

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	A036/15/H/006/2021
2. Name of Authorisation Holder	:	Biols - Pharmaceuticals, Unipessoal, Lda. (Zona Franca da Madeira)
3. Address(es) of Site(s)	:	Avenida Marginal, Cais dos Bacalhoeiros, Armazém n.º 214, Ílhavo, 3830-552 Gafanha da Nazaré, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Alferes Veiga Pestana, 1 L, Escritório 39, Funchal, Ilha da Madeira, 9050-079 Funchal, Portugal
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-03-03
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: Biols - Pharmaceuticals, Unipessoal, Lda. (Zona Franca da Madeira)

, Avenida Marginal, Cais dos Bacalhoeiros, Armazém n.º 214, Ílhavo, 3830-552 Gafanha da Nazaré, 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: Cytostatic, Cytotoxic, Biological and Investigational 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 and 3 PL (Third Party Logistics Providers).

Updating of the Annex 1 regarding the inclusion of the Cytostatic, Cytotoxic, Biological and Investigational medicinal products.

The Authorisation number A036/15/H/006/2021 replaces the previous one with the Authorisation number A036/15/H/005/2020, of 2020-06-25.

Reason for Withdrawing:

Updating of the Annex 1 of WDA regarding the withdrawal of the Narcotic or Psychotropic products
and an updating of Annex 3, due to a change of the Responsible Person.

Union Format for a Wholesale Distribution Authorisation	A036/15/H/006/2021
	Page 1

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