What will be the transition process for Australian and New Zealand manufacturers of prescription and OTC medicines?
Manufacturers of medicines that were licensed by either the TGA or Medsafe prior to the commencement of the Agency will be granted a transitional manufacturing licence that will be valid for two years. These Australian and New Zealand based manufacturers will need to apply to the Agency for a full Agency manufacturing licence within nine months of commencement of the Agency. Following the application period, audits of manufacturing sites will be scheduled. These audits will ensure compliance with the Agency code of GMP and will be completed within two years of commencement of the Agency. Products manufactured by these manufacturers, under an interim manufacturing licence, would be eligible for a full Agency product licence provided that all other Agency requirements were met. Under these circumstances, the full Agency product licence would be subject to the condition that failure to obtain a full manufacturing licence by an agreed date would result in suspension of the product licence.
