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RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	1619 H
2. Name of Authorisation Holder	:	Galliker Transports SA Liège (Belgique)
3. Address(es) of Site(s)	:	Avenue du Parc Industriel, Herstal (Milmort), 4041, Belgium

4. Legally registered address of Authorisation Holder	:	Avenue du Parc Industriel, Herstal (Milmort), 4041, Belgium
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-05-06
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: Galliker Transports SA liège (Belgique)

, Avenue du Parc Industriel, Herstal (Milmort), 4041, 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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: storage of manufacturing intermediates (semi-finished products) on behalf of clients Stockage d'intermédiaires de fabrication (produits semi-finis) pour le compte de donneurs d'ordre

Any restrictions or clarifying remarks (for all users): 3.3 (2-8)° C / (-20 à -24)°C

The MILTE warehouse is limited to storage in ambient conditions.

3.3 (2-8)° C / (-20 à -24)°C

L'entrepôt MILTE est limité au stockage en conditions ambiantes.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	1619 H
	Page 1

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