# The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (revoked) S.I. 2005/2789 · made 10 October 2005 · revised to 14 August 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PDFs: Printed copy https://openlegislation.uk/medicines-for-human-use-manufacturing-wholesale-dealing-and-miscellaneous-amendments-regulations-2005-revoked/pdf/uksi_20052789_en.pdf; Explanatory Memorandum https://openlegislation.uk/medicines-for-human-use-manufacturing-wholesale-dealing-and-miscellaneous-amendments-regulations-2005-revoked/pdf/uksiem_20052789_en.pdf ## Introductory text MEDICINES Made 10th October 2005 Laid before Parliament 10th October 2005 Coming into force 30th October 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 1 Citation, commencement and interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Requirement that manufacturer's licence holders comply with certain obligations in relation to the manufacture and assembly of relevant medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Requirement that manufacturer's licence holders comply with certain obligations in relation to the import from a third country of relevant medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Requirements as to qualified persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Offence relating to the sale and supply of starting materials for use in the manufacture of relevant medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Standard provisions for manufacturer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Additional standard provisions for manufacturers licences which relate to vaccines, toxins and sera . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Requirement that holders of wholesale dealer's licences comply with certain obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Requirement that wholesale dealers deal only with specified persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Requirement as to responsible persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Standard provisions for wholesale dealer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Application of these Regulations to manufacturer's and wholesale dealer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Consequential and other amendments to enactments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Revocations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Transitional provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 1: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE MANUFACTURE AND ASSEMBLY OF RELEVANT MEDICINAL PRODUCTS ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 2: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE IMPORT OF RELEVANT MEDICINAL PRODUCTS FROM A THIRD COUNTRY ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 3: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO VACCINES, TOXINS OR SERA ### Part 1: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO VACCINES ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO SMALLPOX VACCINES ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO BCG VACCINES ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 4: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO TOXINS ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 5: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO SERA ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 4: STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A WHOLESALE DEALER'S LICENCE ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 5: CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS ### Part 1: AMENDMENTS TO THE ACT ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: AMENDMENTS TO ORDERS AND REGULATIONS ## 1 Amendments to the Standard Provisions Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Amendments to the Applications Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Amendments to the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Amendments to the Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 6: TRANSITIONAL PROVISIONS ## 1 Wholesale dealer's licences granted before 30th October 2005 relating to the import of medicinal products from third countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Applications for wholesale dealer's licences made before 30th October 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Manufacturer's and wholesale dealer's licences granted before 30th October 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Explanatory note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . --- Source: https://www.legislation.gov.uk/uksi/2005/2789 (the official version) Page: https://openlegislation.uk/medicines-for-human-use-manufacturing-wholesale-dealing-and-miscellaneous-amendments-regulations-2005-revoked Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.