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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-05-07

RTF Template

Federal Agency For Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	315 H
2. Name of Authorisation Holder	:	Febelco (ORG-100015158 / LOC-100023842)
3. Address(es) of Site(s)	:	Baron De Grubenlaan 3, Wijnegem, 2110, Belgium Industriepark Herdersburg, Gotevlietstraat 94, Brugge, 8000, Belgium Pachtgoedstraat 10, Sint-Niklaas, 9100, Belgium Hezewijk 7, Olen, 2250, Belgium Jan-Baptist Vinkstraat 3, Kortenberg, 3070, Belgium Noordkaai 9, Izegem, 8870, Belgium Dellestraat 57, Heusden-Zolder, 3550, Belgium Rue De L'europe 3, Frameries, 7080, Belgium

4. Legally registered address of Authorisation Holder	:	Eigenlostraat 1, Sint-Niklaas, 9100
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-07-02
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: Febelco

(ORG-100015158 / LOC-100035836)

, Baron De Grubenlaan 3, Wijnegem, 2110, Belgium

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.3: Full line wholesaler
3.3: Authorized temperature for the cold chain : 2-8°C

2.3: Groothandelaar-verdeler
3.3: Toegestane temperatuur voor de koude bewaring : 2-8°C.

Name and address of the site: Febelco

(ORG-100015158 / LOC-100023841)

, Industriepark Herdersburg, Gotevlietstraat 94, Brugge, 8000, Belgium

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.3: Full line wholesaler
3.3: Authorized temperature for the cold chain : 2-8°C

2.3: Groothandelaar-verdeler
3.3: Toegestane temperatuur voor de koude bewaring : 2-8°C.

Name and address of the site: Febelco

(ORG-100015158 / LOC-100035857)

, Pachtgoedstraat 10, Sint-Niklaas, 9100, Belgium

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.3: Full line wholesaler
3.3: Authorized temperature for the cold chain : 2-8°C

2.3: Groothandelaar-verdeler
3.3: Toegestane temperatuur voor de koude bewaring : 2-8°C.

Name and address of the site: Febelco

(ORG-100015158 / LOC-100035837)

, Hezewijk 7, Olen, 2250, Belgium

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.3: Full line wholesaler
3.3: Authorized temperature for the cold chain : 2-8°C

2.3: Groothandelaar-verdeler
3.3: Toegestane temperatuur voor de koude bewaring : 2-8°C.

Name and address of the site: Febelco

(ORG-100015158 / LOC-100035839)

, Jan-Baptist Vinkstraat 3, Kortenberg, 3070, Belgium

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.3: Full line wholesaler
3.3: Authorized temperature for the cold chain : 2-8°C

2.3: Groothandelaar-verdeler
3.3: Toegestane temperatuur voor de koude bewaring : 2-8°C.

Name and address of the site: Febelco

(ORG-100015158 / LOC-100035854)

, Noordkaai 9, Izegem, 8870, Belgium

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.3: Full line wholesaler
3.3: Authorized temperature for the cold chain : 2-8°C

2.3: Groothandelaar-verdeler
3.3: Toegestane temperatuur voor de koude bewaring : 2-8°C.

Name and address of the site: Febelco

(ORG-100015158 / LOC-100035850)

, Dellestraat 57, Heusden-Zolder, 3550, Belgium

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

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.3: Full line wholesaler
3.3: Authorized temperature for the cold chain : 2-8°C

2.3: Groothandelaar-verdeler
3.3: Toegestane temperatuur voor de koude bewaring : 2-8°C.

Name and address of the site: Febelco

(ORG-100015158 / LOC-100078289)

, Rue De L'europe 3, Frameries, 7080, Belgium

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

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): 2.3: Full line whole saler
3.3: Authorized temperature for the cold chain : 2-8°C

2.3: Groothandelaar-verdeler
3.3: Toegestane temperatuur voor de koude bewaring : 2-8°C.

Reason for Withdrawing:

made new WDA due to technical problems with update of the WDA

Union Format for a Wholesale Distribution Authorisation	315 H
	Page 1

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