Thu 29 Oct 2026 09:20:50 BST

Search Company

OMS Organisation Identifier:

OMS Location Identifier:

NCA Reference Key:

Address:

Country:

Active Substance

New Active Substance

Search Site

Create Site

Update Site

Current data stored in EudraGMDP database

Current data stored in OMS

DUNS Number:

NCA Reference Key:

Site Name:

OMS Organisation Identifier:

OMS Location Identifier:

Address Line 1:

Address Line 2:

Address Line 3:

Address Line 4:

City:

County:

Postcode:

Country:

Additional Details on Units Inspected

Site under Compliance Management:

Compliance Management comments:

Characters remaining:4000/4000

Overwrite with current OMS data.:

New Active Substance Importation

Active Substance*

Active Substance (English):
Active Substance (NL):
NCA Reference Key:

3rd Country Manufacturer

3rd Country Manufacturer	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

3rd Country Distributor

3rd Country Distributor	OMS Location Identifier	OMS Organisation Identifier	Legal Address	NCA Reference Key	Confidential	Edit	Delete
No records found.

Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-02-20

RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	1573 H
2. Name of Authorisation Holder	:	Clinigen Clinical Supplies Management SA
3. Address(es) of Site(s)	:	Watson & Crick Hill, Rue Granbonpré, 11, Mont-Saint-Guibert, 1435, Belgium

4. Legally registered address of Authorisation Holder	:	Watson & Crick Hill, Rue Granbonpré, 11, Mont-Saint-Guibert, 1435, Belgium
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	:	2021-01-21
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: Clinigen Clinical Supplies Management SA

, Watson & Crick Hill, Rue Granbonpré, 11, Mont-Saint-Guibert, 1435, Belgium

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

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 2.1 Also procurement of medicinal products coming from countries of the European Economic Area (EEA) other than Belgium.
3.3 Authorized temperature for the cold chain :
between +2°C and +8°C
between -15°C and -25°C
less than -60 °C
less than -150 °C

2.1 Egalement acquisition de médicaments via d'autres pays de l'Espace économique européen (EEE) que la Belgique.
3.3 Température autorisée pour la chaîne du froid :
entre +2°C et +8°C
entre -15°C et -25°C
inférieur à -60 °C
inférieur à -150 °C

Reason for Withdrawing:

not XDC

Union Format for a Wholesale Distribution Authorisation	1573 H
	Page 1

Loading, please wait