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The WDA has been withdrawn, withdrawn date is: 2026-03-25

RTF Template

State Agency Of Medicines

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	49
2. Name of Authorisation Holder	:	Tamro Eesti OÜ (ORG-100019516 / LOC-100028286)
3. Address(es) of Site(s)	:	Saue Vald, Parnu Mnt 501, Laagri Alevik, 76401, Estonia

4. Legally registered address of Authorisation Holder	:	Saue Vald, Parnu Mnt 501, Laagri Alevik, 76401, Estonia
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-01-11
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: Tamro Eesti OÜ

(ORG-100019516 / LOC-100028286)

, Saue Vald, Parnu Mnt 501, Laagri Alevik, 76401, Estonia

Human medicinal products

Veterinary 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

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) procurement and supply of radiopharmaceuticals

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.3. Other products: (please specify here or make a reference to Annex 5) Ref to Annex 1 Remarks below

Any restrictions or clarifying remarks (for all users): Annex 1, section 3.3 as follows:
Medicinal products derived from blood,
Immunological medicinal products,
Radiopharmaceuticals (including radionuclide kits)

*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.

Reason for Withdrawing:

changed with decision nr KTM-7/26/28

Union Format for a Wholesale Distribution Authorisation	49
	Page 1

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