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RTF Template

Latvian State Agency of Medicines

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	LPN-34/6
2. Name of Authorisation Holder	:	Sabiedrība ar ierobežotu atbildību "MAGNUM MEDICAL"
3. Address(es) of Site(s)	:	Ulbrokas iela 23, Rīga, LV-1021, Latvia

4. Legally registered address of Authorisation Holder	:	Ulbrokas iela 23, Rīga, LV-1021, Latvia
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	:	2016-11-10
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: Sabiedrība ar ierobežotu atbildību "MAGNUM MEDICAL" zāļu lieltirgotava

, Ulbrokas iela 23, Rīga, LV-1021, Latvia

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

2.5. Other activities(s): distribution of medicinal products of contractual partners

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.1.4. Radiopharmaceuticals (including radionuclide kits)

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: 3.4.1. veterinary medicinal products

Any restrictions or clarifying remarks (for all users): 3.1.1. narcotic and equivalent thereto psychotropic medicinal products or substances or psychotropic medicinal products or substances; 3.1.1.1. psychotropic medicinal products; 3.1.1.3. narcotic and equivalent thereto psychotropic medicinal products

*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	LPN-34/6
	Page 1

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