Safeguarding public health

Implementation of the new

European Legislation
Dr June Raine 23 November 2005

Impact of new legislation

Choice Empowerment Safety
Slide 2 23 November 2005

Scope of presentation
Data exclusivity for

switch applications
Renewals Progress in UK

implementation
Slide 3 23 November 2005

UK implementation progress
3 legislative provisions implemented early:
switch exclusivity user testing of PILs safety reporting
Slide 4 23 November 2005

Data exclusivity
Article 74a Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for a change of classification of the same substance for one year after the initial change was authorised

Slide 5 23 November 2005

Switch exclusivity guidance

MHRA Guidance on Application for Exclusivity for change in legal status of a medicine - June 2005

developed by UKs Reclassification Strategy Group - stakeholders include professional, industry and patient representatives complementary to EU guidance

Slide 6 23 November 2005

European Guideline
European Commission has published updated

reclassification guideline in draft on website

Parts 1 & 2 are unchanged New part 3 explains which applications would

be eligible for data protection

New part 4 explains procedure to be followed
Slide 7 23 November 2005

What type of data qualifies?

Focus is on the interpretation of

Results of significant pre-clinical tests or clinical trials

Decisions will be made by Competent Authority on case by case basis
Slide 8 23 November 2005

Pre-clinical tests
Additional pre-clinical work later on in the lifecycle of a product may have little practical relevance for a switch application Possible example new in vitro data generated on antimicrobial resistance patterns

Slide 9 23 November 2005

Clinical trials
New data should make unequivocal contribution to decision to reclassify
Examples include data that: Demonstrates safe use in non-prescription setting Identifies target population Involves patients / consumers in a pharmacy based trial and results in guidance on safe effective use by pharmacist
Slide 10 23 November 2005

Summary MHRA position

Applicants encouraged to include data in applications which are essential for a successful switch and will be exclusive to the applicant The data cannot be used in consideration of subsequent applications for same substance for period of one year. Grant of an authorisation, supported by exclusivity evidence, will be published on the MHRA website
Slide 11 23 November 2005

Renewals - legislation
Marketing authorisation renewed after 5 years on

basis of re-evaluation of risk-benefit

Renewal submission - consolidated quality,

safety and efficacy, including all variations at least 6 months before expiry
Once renewed, MA will be valid for unlimited

period unless justified on grounds relating to pharmacovigilance, to proceed with one additional five-year renewal
Slide 12 23 November 2005

Renewals guidelines
in Centralised Procedure

Processing of Renewals

Processing of Renewals

in MR and Decentralised

Volume 9 A of the Rules

Governing Medicinal Products in the European Union

Slide 13 23 November 2005

Transitional arrangements
For products not yet renewed - current

PSUR cycle to be maintained up to first renewal

For products already renewed at least once

PSURs to be submitted no later than 30 October 2008 - 3 years after implementation

MHRA will not be asking for further renewal

for national products

Slide 14 23 November 2005

Summary
New legislation supports

choice,empowerment, safety
UK guidance, EU Guidelines

complementary
New climate of opportunity

for OTC manufacturers

Slide 15 23 November 2005

Safeguarding public health

Implementation of the new European Legislation

Dr June Raine 23 November 2005