Step 1.3 (b) Patent and Data Exclusivity status

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For the purpose of registration of generic products, PRH shall provide patent declarations as below:

i) PRH shall comply with all legal provisions in Malaysia;

ii) The government/ authority is not liable for any offence committed by the PRH as a result of any breach of any law; and

iii) PRH shall indemnify the government if any claim is made against the government as a result of any breach of any law by the applicant whether intentionally or otherwise.

PRH shall conform to Patent Act 1983 (Act 291) and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration is yet to expire.