Ministry of Health and Family Welfare has amended the Drugs and Cosmetics Rules, 1945 vide notification No. G.S.R. 101(E) dated 11-02-2020 regarding the Marketer. These rules may be called the Drugs and Cosmetics (Amendment) Rules, 2020.
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Q1. Weather Medical Representative is responsible for the quality of dugs of the manufacturer or marketer as per above notification.
Ans: No, as per notification Medical Representative is not responsible for the quality of drugs.
Q2. Shall Marketer be responsible for the quality of drugs ?
Ans: Marketer shall be responsible for the quality of drugs as well as other regulatory compliances along with the manufacturer.
Q3. From which date this notification shall come into force ?
Ans: This notification shall come into force on the 1st day of March, 2021.
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Q4. Whether an agreement is required between the Manufacturer and Marketer ?
Ans: Yes, an agreement is required between the manufacture and the marketer.
Q5. Can marketer label or affix his name and address on the labels of the drug ?
Ans: Yes, Marketer can label or affix his name and address on the labels of the drug.
FAQs – on Notification: Marketer of drugs
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