Module Head: Prof. Dr. Harald G. Schweim, Prof. Dr. Barbara Sickmüller

	Topics
	Maintaining marketing authorization: formal aspects Application for extending marketing authorization Renewal of marketing authorization as per § 31 AMG (German Drug Law) Renewal of registration as per § 39 AMG Application form Attachments to the application form Deadlines according to the German Drug Law Failure to meet deadlines Legal options if a deadline is missed Harmonization of renewal data (common renewal date) national / EU Decision by authority Imposed conditions Grounds for denial Legal options in the case of a rejection Significance of the Federal Gazette EU procedures: renewal: MRP (CMS/RMS), centralized procedure Traditional pharmaceutical products Homeopathic products Authorization-maintaining measures Notices of variation / Variations Updating the regulatory dossier Pharmacovigilance Pharmacovigilance planning and evaluation during the post-authorization period Step Plan procedure (national / EU-wide) ADR reporting procedures (national / EU-wide)