GMP Committee response
European Directive 2001/83/EC, Article 40(2) states that a manufacturing authorisation “shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.” The Glossary of the EU GMP Guide defines ‘Manufacture’ as “All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of medicinal products and the related controls.” So, any partial product manufacture does require a manufacturing authorisation. Starting materials, such as excipients, and packaging materials are not required to be manufactured under a manufacturing authorisation. The manufacture of Active Pharmaceutical Ingredients does not normally require a manufacturing authorisation, but does require a registration with the competent authority of the Member State in which the site is established. However it should be noted that some competent authorities do require the manufacture of biologic/Biotech API, also referred to as Drug Substance, to be performed under a Manufacturing Authorisation. This also applies to the EEA and UK where national legislation is based on this EU Directive. Legislation may differ outside EU/EEA/UK.
In the case of a combination device / product the device should carry CE marking.