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APPENDIX TO THE ANNEX TO THE TRIPS AGREEMENT

APPENDIX TO THE ANNEX TO THE TRIPS AGREEMENT

 

Assessment of Manufacturing Capacities in the Pharmaceutical Sector

 

Least-developed country Members are deemed to have insufficient or no manufacturing capacities in the pharmaceutical sector.

For other eligible importing Members` insufficient or no manufacturing capacities for the produces) in question may be established in either of the following ways:

(i) the Member in question has established that it has no manufacturing capacity in the pharmaceutical sector;

or

(ii) where the Member has some manufacturing capacity in this sector, it has examined this capacity and found that, excluding any capacity owned or controlled by the patent owner, it is currently insufficient for the purposes of meeting its needs. When it is established that such capacity has become sufficient to meet the Member's needs, the system shall no longer apply.