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Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Paracetamol (Pharmacare)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: Sterling Healthcare Limited, Pune, India
Note: This consent is given subject to the following conditions:
  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other paracetamol tablet, 500mg with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or under supply arrangements with PHARMAC.
Note: This consent is valid for two years from the date of publication of this notice.


Dated this 31st day of May 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

Publication Date
3 Jun 2021

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2021-go2141
Title
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