{
  "url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.2/division-3.2.2/division-3.2.2.2",
  "json_url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.2/division-3.2.2/division-3.2.2.2.json",
  "legislation": "eudr/2001/83",
  "legislation_title": "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use",
  "legislation_url": "https://openlegislation.uk/eu-directive-2001-83",
  "path": "annex/I/part/I/division/3/division/3.2/division/3.2.2/division/3.2.2.2",
  "kind": "division",
  "number": "3.2.2.2",
  "heading": "Pharmaceutical development",
  "text": "This chapter shall be devoted to information on the development studies conducted to establish that the dosage form, the formulation, manufacturing process, container closure system, microbiological attributes and usage instructions are appropriate for the intended use specified in the marketing authorisation application dossier.\nThe studies described in this chapter are distinct from routine control tests conducted according to specifications. Critical parameters of the formulation and process attributes that can influence batch reproducibility, medicinal product performance and medicinal product quality shall be identified and described. Additional supportive data, where appropriate, shall be referenced to the relevant chapters of Module 4 (Non Clinical Study Reports) and Module 5 (Clinical Study Reports) of the marketing authorisation application dossier.\na)) The compatibility of the active substance with excipients as well as key physicochemical characteristics of the active substance that can influence the performance of the finished product or the compatibility of different active substances with each other in the case of combination products, shall be documented.\nb)) The choice of excipients, in particular relative to their respective functions and concentration shall be documented.\nc)) A description of the development of the finished product shall be provided, taking into consideration the proposed route of administration and usage.\nd)) Any overages in the formulation(s) shall be warranted.\ne)) As far as the physiochemical and biological properties are concerned, any parameter relevant to the performance of finished product shall be addressed and documented.\nf)) The selection and optimisation of the manufacturing process as well as differences between the manufacturing process(es) used to produce pivotal clinical batches and the process used for manufacturing the proposed finished medicinal product shall be provided.\ng)) The suitability of the container and closure system used for the storage, shipping and use of the finished product shall be documented. A possible interaction between medicinal product and container may need to be considered.\nh)) The microbiological attributes of the dosage form in relation with non-sterile and sterile products shall be in accordance with and documented as prescribed in the European Pharmacopoeia.\ni)) In order to provide appropriate and supportive information for the labelling the compatibility of the finished product with reconstitution diluent(s) or dosage devices shall be documented.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/3/division/3.2/division/3.2.2/division/3.2.2.2",
    "retrieved_at": "2026-11-01T15:22:59.083752+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}