Medicines and Healthcare products Regulatory Agency

WHOLESALE DISTRIBUTION AUTHORISATION

(MEDICINAL PRODUCTS FOR HUMAN USE)

WHOLESALE DISTRIBUTION AUTHORISATION (MEDICINAL PRODUCTS FOR HUMAN USE)
1. Authorisation NumberUK WDA(H) 23056
2. Name of Authorisation HolderSCHWABE PHARMA (UK) LIMITED
3. Legally registered address of Authorisation Holder SCHWABE PHARMA (UK) LIMITED, ALEXANDER HOUSE, MERE PARK, DEDMERE ROAD, MARLOW, SL7 1FX, UNITED KINGDOM
4. Address(es) of Site(s)

SCHWABE PHARMA (UK) LIMITED, ALEXANDER HOUSE, MERE PARK, DEDMERE ROAD, MARLOW, SL7 1FX, UNITED KINGDOM

5. Scope of authorisation (complete for each site under 4) ANNEX 1
6. Legal basis of authorisation Regulation 18 of the Human Medicines Regulations 2012
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation Confidential
8. Date07/09/2021
9. 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 Additional provisions
ANNEX 1
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site:

SCHWABE PHARMA (UK) LIMITED, ALEXANDER HOUSE, MERE PARK, DEDMERE ROAD, MARLOW, SL7 1FX, UNITED KINGDOM

Site Details for 4.6 Homeopathic products
1. MEDICINAL PRODUCTS
  1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration)
2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS
  2.1 Procurement
  2.6 Products imported from countries on a list
  2.6a Products certified under Article 51 of Directive 2001/83/EC
Any restrictions or clarifying remarks (for all users)
4 Categories of Products Handled at this Site: 4.5 Traditional Herbal Medicinal products