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Regulatory Roadmap for the development of human medicinal Products (Europe focus)

Just click on the various stages below to reveal the information.

	Terminate Licence
DESCRIPTION	The voluntary, or otherwise, termination of the licence to manufacture and market a particular product; At the end of the product life-cycle, i.e. when the product is off-patent and generic competition has eroded product revenue, the product may be removed from sale following withdrawal of the product from the supply chain and termination of all existing product licences. Alternatively, the product may be divested and the product licences transferred to the new owner of the product.
INPUTS	Product Licence Submission for Termination / Transfer Request Product Divestment
PROCESSES	GMP : Product Manufacturing GMP : Distribution GCP, GMP & GPVP : Post Marketing Studies GCP & GPVP : Pharmacovigilance
REGULATIONS	Control of Substances Hazardous to Health (COSHH) Commission Regulation EC/2141/96 regarding transfer of a marketing authorisation Commission Regulation EC/1084/2003 regarding variations Commission Regulation EC/ 1085/2003/ regarding variations Commission Regulation (EC) No 1234/2008 regarding variations Commission Directive 2009/53/EC (amending Directive 2001/82/EC and 2001/83/EC) regarding variations to marketing authorisations UK Medicines Act 1968 Product Manufacturing MHRA Orange Guide Distribution MHRA Good Distribution practice Pharmacovigilance Regulation EC/726/2004 Commission Regulation EC/540/95 regarding suspected adverse reactions which are not serious Commission Directive 2001/83/EC Guideline on the definition of a potential serious risk to public health 2006/C 133/05 Good Clinical Practice Directive 2001/20/EC Commission Directive 2003/94/EC regarding GMP of IMPs Commission Directive 2005/28/EC
GUIDANCE	Volume 9A of the Rules Governing Medicinal Products in the EU MHRA The Good Pharmacovigilance Practice Guide (Purple Guide) publication Eudralex Volume 2 Notice to Applicants Eudralex Volume 10 Clinical trial guidelines Computer Systems Validation GAMP5 FDA Guidelines for Computer Systems Validation
OUTPUTS	Confirmation of Cancellation of Licence Or Agreement of Licence Transfer
RQA Courses/Seminars/eLearning	Professional Development Courses and Seminars eLearning
RQA Publications	Good Clinical Laboratory Practice (GCLP) Good Clinical Practice Regulatory Authority Inspections The Role of the Monitor in Veterinary Clinical Studies Pharmacovigilance Auditing Pharmacovigilance Inspection Guidance

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