During the registration process quality of medicinal products is assessed on the basis of chemical documentation of active substance and chemical, pharmaceutical and biological documentation of finished product.

In the European Union a common format of documentation – CTD (Common Technical Document) is applicable for every the type of regulatory procedure (centralized procedure CP, decentralized procedure DCP mutual recognition procedure MRP and national procedure NP).

Data concerning quality of medicinal product are included in Module 3.2.S and must contain the following information:

3.2.S.1 General Information

3.2.S.2 Manufacture

3.2.S.3 Characterisation

3.2.S.4 Control of Drug Substance

3.2.S.5 Reference Standards or Materials

3.2.S.6 Container Closure System

3.2.S.7 Stability

There are three possible ways for submission of documentation of quality of the active substance:

· Active Substance Master File (ASMF)

· Certificate of Suitability of the Monographs of the European Pharmacopoeia

· Module 3.2.S

European legislation requires manufacturing of every active substance according to GMP.

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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. The Pharmacopoeia in preparation and assessment of pharmaceutical, chemical and biological documentation of medicinal products
3. EUROPEAN CRITERIA FOR QUALITY ASSESSMENT OF CHEMICAL AND BIOLOGICAL MEDICINAL PRODUCTS DURING THE REGISTRATION PROCESS