Quality of medicinal product is assessed in the authorization process on the basis of chemical, pharmaceutical and biological documentation attached to the application for granting Marketing Authorization. This documentation forms Module 3 of registration dossier in the format of Common Technical Document - CTD.  CTD indicates only the presentation and format of the data and documentation which should be attached to the application form. The testing procedures documenting the quality of active substance(s), excipient(s), pharmaceutical form and packaging are specified by the European Pharmacopoeia or its Polish version (Polish Pharmacopoeia) and the relevant guidelines. The guidelines are listed in annex to module 3.  They are available on the EMA website: http://www.ema.europa.eu/ htms/human/humanguidelines/quality.htm

Active substance(s) and excipient(s) which have no individual monographs of pharmacopoeia should be compliant to the requirements of the general monograph “Substances for pharmaceutical use”.

In case where the above mentioned monographs are described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia can be accepted. In such cases, the applicant shall submit a copy of the monograph accompanied by the validation of the analytical procedures contained in the monograph and by a translation where appropriate.

The quality standards represented by monographs are valid only where the articles in question are produced within the framework of a suitable quality system.

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1. Experience of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in assessment of quality of medicinal products
2. Registration dossier of chemical active substance
3. EUROPEAN CRITERIA FOR QUALITY ASSESSMENT OF CHEMICAL AND BIOLOGICAL MEDICINAL PRODUCTS DURING THE REGISTRATION PROCESS