Regulation 37 Manufacturing and assemblyF1

those substances have been manufactured in accordance with good manufacturing practice for active substances; and

those substances have been distributed in accordance with the guidelines on good distribution practice for active substances.

that the manufacturer or distributor of an active substance used by the licence holder has complied with the requirements of good manufacturing practice and good distribution practice for active substances by means of audits performed—

that unless the active substance is imported into Great Britain from a country other than an approved country for import or into Northern Ireland from a country other than an EEA State from a third country, any manufacturers, importers or distributors supplying active substances to the licence holder—

the authenticity and quality of the active substance.

excipients are suitable for use in a medicinal product by—

the suitability of the excipient is ascertained on the basis of a formalised risk assessment as described F4F5... in the guidelines which apply under or by virtue of regulation C17 F6(including in the case of a listed NIMAR product for sale or supply from Great Britain to Northern Ireland) ;

the assessment under sub-paragraph (b) takes account of—

the authenticity and quality of any excipient used is verified; and

the measures taken under this paragraph are documented by the licence holder.

the manufacturer’s licence; F7...

in the case of a product for supply as an EAMS medicinal product, the conditions attached to the EAMS scientific opinion in respect of the product; F9...

in the case of an MM medicinal product, the MM master file;

in the case of a POC medicinal product, the POC master file; and

F11in the case of a product for sale or supply—

applying to the medicinal products.

the standards of quality and safety specified in F14the Blood Quality and Safety Regulations 2005; or

equivalent standards.

knows or suspects; or

has reasonable grounds for knowing or suspecting,