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RTF Template

Danish Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	105525
2. Name of Authorisation Holder	:	Air Liquide Danmark A/S (ORG-100021447 / LOC-100091831)
3. Address(es) of Site(s)	:	Hoeje Taastrup Vej 44, Taastrup, Hovedstaden, 2630, Denmark Energivej 7/9 Paarup, Engesvang, Midtjylland, 7442, Denmark Frejasvej 2, Hedensted, Midtjylland, 8722, Denmark

4. Legally registered address of Authorisation Holder	:	Uraniavej 6, Horsens, Midtjylland, 8700
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	:	2026-09-16
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: Air Liquide Danmark A/S

(ORG-100021447 / LOC-100091880)

, Hoeje Taastrup Vej 44, Taastrup, Hovedstaden, 2630, Denmark

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal gases

Any restrictions or clarifying remarks (for all users): 1.2 Medicinal products under a compassionate use permit received from site Energivej 7-9, Pårup, 7442 Engesvang. Distribution of these medicinal products is restricted to Denmark.

Name and address of the site: Air Liquide Danmark A/S

(ORG-100021447 / LOC-100053475)

, Energivej 7/9 Paarup, Engesvang, Midtjylland, 7442, Denmark

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal gases

Name and address of the site: Air Liquide Danmark A/S

(ORG-100021447 / LOC-100030143)

, Frejasvej 2, Hedensted, Midtjylland, 8722, Denmark

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medicinal gases

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	105525
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