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RTF Template

Federal Agency for Medicines and Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	1747 H
2. Name of Authorisation Holder	:	Leo Pharma NV
3. Address(es) of Site(s)	:	Duwijckstraat 17, Lier, 2500, Belgium

4. Legally registered address of Authorisation Holder	:	Duwijckstraat 17, Lier, 2500, 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	:	2019-01-21
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: Leo Pharma NV

, Duwijckstraat 17, Lier, 2500, Belgium

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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 : 2-8°C

2.1.: Alsook het verkrijgen van geneesmiddelen uit landen van de Europese Economische Ruimte (EER) anders dan België.
3.3.: Toegestane temperatuur voor de koude bewaring : 2-8°C

*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	1747 H
	Page 1

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