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

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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 Licenses.

Alternatively, the product may be divested and the product licenses 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

Distribution

Pharmacovigilance

Good Clinical Practice

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

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