Regulation 50 Accompanying material

in the case of an application under the unfettered access route—

in all other cases, the material specified in Schedule 8,

a general description of the system together with a detailed description of the components of the system which may affect the composition or quality of the daughter nucleid preparation; and

qualitative and quantitative particulars of the eluate or the sublimate.

in the case of a UKMA(NI) or a F6UKMA(UK)(Category 2), is liable to be imported from a country other than an EEA State, or

in the case of a F7UKMA(UK)(Category 1), is liable to be imported,

guidance on the presentation and content of the material specified in Schedule 8;

scientific guidelines relating to the quality, safety and efficacy of medicinal products; and

guidelines describing the active substance manufacturing process and process controls.

the guidance published by the European Commission in the rules governing medicinal products in the European Community, Volume 2B, Notice to Applicants, Medicinal Products for human use, Presentation and content of the dossier, Common Technical Document;

the scientific guidelines relating to the quality, safety and efficacy of medicinal products as adopted by the Committee for Medicinal Products for Human Use and published by the EMA and the other pharmaceutical Community guidelines published by the European Commission in the different volumes of the rules governing medicinal products in the European Community; and

guidelines published by the EMA for the purposes of paragraph 3.2.1.2 of Part I of Annex I to the 2001 Directive.

regulation 50A (requirement for certain applications to include results of paediatric investigation plan);

regulation 50E (application for paediatric use marketing authorisation);

regulation 50F (other applications including paediatric indications);

regulation 50G (applications relating to orphan medicinal products);

regulation 50H (applications relating to advanced therapy medicinal products);

regulation 50I (applications relating to conditional marketing authorisations);

regulation 50J (applications relating to medicinal products containing or consisting of genetically modified organisms);

regulation 51 (application for UKMA(NI) relating to generic medicinal products);

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regulation 51B (application for UKMA(UK) relating to generic medicinal products);

regulation 52 (application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc);

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regulation 52B (application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc);

regulation 53 (application for UKMA(NI) relating to similar biological medicinal products);

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regulation 53B (application for UKMA(UK) relating to similar biological medicinal products);

regulation 54 (applications relating to products in well-established medicinal use);

regulation 55 (applications relating to new combinations of active substances);

regulation 56 (applications containing information supplied in relation to another medicinal product with consent); and

Schedule 10 (applications relating to national homoeopathic products).