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RTF Template

Chief Pharmaceutical Inspectorate

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	NZOH.5100.61.2023.MG.4
2. Name of Authorisation Holder	:	Reckitt Benckiser (Poland) S.A. (ORG-100003666 / LOC-100006785)
3. Address(es) of Site(s)	:	Ul. Logistyki 3, Mszczonow, 96-320, Poland

4. Legally registered address of Authorisation Holder	:	Ul. Okunin 1, Nowy Dwor Mazowiecki, 05-100
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-08-23
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: Reckitt Benckiser (Poland) S.A.

(ORG-100003666 / LOC-100082819)

, Ul. Logistyki 3, Mszczonow, 96-320, Poland

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

Any restrictions or clarifying remarks (for all users): Asortyment produktów leczniczych ograniczony do produktów leczniczych, dla których podmiotem odpowiedzialnym jest Reckitt Benckiser (Poland) S.A. – dotyczy produktów leczniczych marki Nurofen, Strepsils, Gaviscon, które mają kategorię OTC (wydawane bez przepisu lekarza) i nie są objęte serializacją w myśl rozporządzenia Delegowanego Komisji (UE) 2016/161 z dnia 2 października 2015 r.

*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	NZOH.5100.61.2023.MG.4
	Page 1

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