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RTF Template

State Agency Of Medicines

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	L00148
2. Name of Authorisation Holder	:	Mylab SIA (ORG-100052611 / LOC-100100024)
3. Address(es) of Site(s)	:	Ziemelu Iela 4, Lidosta Riga, Marupes Pagasts, Marupes Novads, Riga, LV-1053, Latvia

4. Legally registered address of Authorisation Holder	:	Roberta Hirsa Iela 1, Riga, LV-1045
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	:	2025-12-12
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: Mylab SIA

(ORG-100052611 / LOC-100093687)

, Ziemelu Iela 4, Lidosta Riga, Marupes Pagasts, Marupes Novads, Riga, LV-1053, Latvia

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*

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) between 8°C and 15°C

3.3. Other products: (please specify here or make a reference to Annex 5) medicinal products derived from human blood and plasma, immunological medicinal products

Any restrictions or clarifying remarks (for all users): psychotropic medicinal products,

holding of medicinal products in Ziemeļu iela 4, Lidosta "Rīga", Mārupes pagasts, Mārupes novads, LV-1053, Latvia (site of contract wholesale distribution SIA "GP TERMINALS", number of authorisation Nr.L00112)

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

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

Union Format for a Wholesale Distribution Authorisation	L00148
	Page 1

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