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RTF Template

Icelandic Medicines Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	012
2. Name of Authorisation Holder	:	Linde Gas ehf. (ORG-100029281 / LOC-100082447)
3. Address(es) of Site(s)	:	Budahella 8, Hafnarfjoerdur, 221, Iceland

4. Legally registered address of Authorisation Holder	:	Budahella 8, Hafnarfjoerdur, 221
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC The Icelandic Medicinal Products Act No 100/2020, Art. 28.
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-06-07
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: Linde Gas ehf.

(ORG-100029281 / LOC-100082447)

, Budahella 8, Hafnarfjoerdur, 221, Iceland

Human medicinal products

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

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): 1.2 Sale (Supply) of medicinal products exempted from MA by the Icelandic Medicines Agency is only approved for patients in Iceland.

2. This wholesale distribution authorization is restricted to distribution of medicinal gases.

*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	012
	Page 1

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