ABSTRACT
INTRODUCTION Information on the container-closure system is required in a dossier for a marketing authorisation application (MAA) and the relevant information will be included in a number of places in the Common Technical Document (CTD) format (1). The primary placement of information on container-closure systems is in Module 3 at Section 3.2.S.6 (for the drug substance) and at Section 3.2.P.7 for the drug product (dosage form). In addition, there will be some information included in Module 2.3 (Quality Overall Summary) based on the information in Module 3. A certain amount of information will also need to be added to Module 1-perhaps in the application form but certainly in the product information (which may be intended for the prescriber or the patient or both).
