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RTF Template

Medicines and Healthcare Products Regulatory Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	UK WDA(H) 15184
2. Name of Authorisation Holder	:	LEXON (UK) LIMITED
3. Address(es) of Site(s)	:	UNIT 10, PALMERS ROAD, EAST MOONS MOAT, REDDITCH, B98 0RF, United Kingdom UNIT 3, PHILIPPA WAY, LEEDS, LS12 6LS, United Kingdom 3A YOUNG PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0TD, United Kingdom UNIT 18, OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, B98 0RE, United Kingdom NORCHEM HOUSE, CHILTON INDUSTRIAL ESTATE, CHILTON, FERRYHILL, DL17 0PD, United Kingdom UNIT 11, PALMERS ROAD, EAST MOONS MOAT, REDDITCH, B98 0RF, United Kingdom

4. Legally registered address of Authorisation Holder	:	UNIT 18, OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, B98 0RE, United Kingdom
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-12-08
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: LEXON (UK) LIMITED

, UNIT 10, PALMERS ROAD, EAST MOONS MOAT, REDDITCH, B98 0RF, United Kingdom

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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

Any restrictions or clarifying remarks (for all users): 4. CATEGORIES OF PRODUCTS HANDLED AT THIS SITE
4.1 Prescription Only Medicines
4.2 General Sales List
4.4 Pharmacy

Name and address of the site: LEXON (UK) LIMITED

, UNIT 3, PHILIPPA WAY, LEEDS, LS12 6LS, United Kingdom

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): 4. CATEGORIES OF PRODUCTS HANDLED AT THIS SITE
4.1 Prescription Only Medicines
4.2 General Sales List
4.4 Pharmacy
4.5 Traditional Herbal Medicinal products

Name and address of the site: LEXON (UK) LIMITED

, 3A YOUNG PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0TD, United Kingdom

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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: LEXON (UK) LIMITED

, UNIT 18, OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, B98 0RE, United Kingdom

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

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

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: LEXON (UK) LIMITED

, NORCHEM HOUSE, CHILTON INDUSTRIAL ESTATE, CHILTON, FERRYHILL, DL17 0PD, United Kingdom

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

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Name and address of the site: LEXON (UK) LIMITED

, UNIT 11, PALMERS ROAD, EAST MOONS MOAT, REDDITCH, B98 0RF, United Kingdom

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

*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	UK WDA(H) 15184
	Page 1

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