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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-07-10

RTF Template

National Authority Of Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	A023/14/H/005/2024
2. Name of Authorisation Holder	:	Janssen Cilag Farmaceutica Lda. (ORG-100002627 / LOC-100044071)
3. Address(es) of Site(s)	:	Praceta Vale Da Fonte Coberta 153 And 167, Alcochete, 2894-002, Portugal

4. Legally registered address of Authorisation Holder	:	Edificio 9, Lagoas Park, Porto Salvo, 2740-262, Portugal
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	:	2024-08-07
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: Janssen Cilag Farmaceutica Lda.

(ORG-100002627 / LOC-100075476)

, Praceta Vale Da Fonte Coberta 153 And 167, Alcochete, 2894-002, Portugal

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

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Cytotoxic medicinal products.

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

Updating of the Authorised Site, regarding a toponymy change in the Address of the Site.

Reason for Withdrawing:

Updating of the Annex 1 regarding the inclusion of the reference to CAR-T Cell Products.

Union Format for a Wholesale Distribution Authorisation	A023/14/H/005/2024
	Page 1

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