E-drug: Registration of nearly-off-patent drugs?
Dear E-druggers,
Generic drug companies in South Africa are requesting registration of
their products ahead of the day that the original patent expires.
What are the regulations or practices in other countries: at what date
before patent expiry will a Drug Regulatory Authority entertain a
generic drug application?
Would a Drug Regulatory Authority breach any patent laws by investigating
efficacy, safety and quality of the proposed generic competitor ahead of
patent expiry?
Obviously marketing of an approved generic can only start from the day the
original patent expires.
Bada Pharasi
Chief Director,
Dept of Health,
South Africa
Fax +27-12-3244525
Email: hall032@hltrsa.pwv.gov.za
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