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Explanatory note

Original text. Later amendments are not shown.

These Regulations amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 by adding two new Schedules containing further standard provisions which may be incorporated in licences, namely—

  • (a) standard provisions for manufacturer's licences relating to all vaccines, smallpox vaccine, BCG vaccine, toxins and sera, and

  • (b) standard provisions for product licences relating to medicinal products which contain the substances listed in paragraphs 1 to 35 of Schedule 1 to the Medicines (Control of Substances for Manufacture) Order 1971, being substances the purity and potency of which cannot be tested by chemical means.