# The Human Medicines Regulations 2012, Regulation 37A: Manufacturing and assembly of MM medicinal products: additional requirements


In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (MM) must ensure that—
(a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the modular units specified in the MM master file; and
(b) only the MM medicinal products specified in the licence are manufactured or assembled at the modular units specified in the MM master file.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/37A (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-37A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.