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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-12-05

RTF Template

National Authority of Medicines and Health Products, I.P.

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A018/21/H/002/2022
2. Name of Authorisation Holder	:	Labatec Farmaceutica S.A. (ORG-100034187 / LOC-100054086)
3. Address(es) of Site(s)	:	Rua Republica Da Coreia N 20 20a, Sintra, 2710-705, Portugal

4. Legally registered address of Authorisation Holder	:	Rua Republica Da Coreia N 20 20a, Sintra, 2710-705
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC National legal basis of authorisation: Art. 94.º of Decree-law 176/2006, of 30th August
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-06-02
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: Labatec Farmaceutica S.A.

(ORG-100034187 / LOC-100054086)

, Rua Republica Da Coreia N 20 20a, Sintra, 2710-705, Portugal

Human medicinal products

1. MEDICINAL PRODUCTS

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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Oncological medicinal products

Any restrictions or clarifying remarks (for all users): WDA scope activity - Wholesale Distributor.

Complete Legal and Site Address: Rua República da Coreia, n.º 20 - 20 A,
Zona Industrial de São Carlos - 2710-705 Sintra

Updating of the Annex 3 regarding a change of the Responsible Person.

Reason for Withdrawing:

Updating of the Annex 1 regarding the inclusion of the Herbal medicinal products.

Union Format for a Wholesale Distribution Authorisation	A018/21/H/002/2022
	Page 1

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