Therapeutic Goods Administration (TGA)
R2 Pharma Solutions can assist with your product registration with the TGA for market entry into Australia. Our TGA consultants will guide you through the process and costs involved. We specialise in complementary medicines, listed medicines, over-the-counter medicines and medical device regulations within the TGA.
Listed and Complementary medicines
These are the class of products that is often known as supplements. For example vitamin supplements, herbal tablets/capsules, traditional medicines etc. When entered into ARTG, product will have an AUST L number. This is the popular, cost effective and less time consuming pathway for majority of the medicines approved by TGA. We can assist with complete compliance against the TGA regulation of listed medicines including clinical evidence package and if required GMP clearance for overseas manufacturing facility.
AICIS – Industrial Chemical Regulations
Formally known as NICNAS, all chemicals that are not regulated by the TGA or APVMA are regulated under AICIS. All industrial chemicals must be reviewed against the regulation of AICIS. We can assist in reviewing your product against AICIS compliance. We can also assist with new chemical categorisation or assessment applications with AICIS.
Globally Harmonised System (GHS) and Australian Dangerous Goods (ADG) Regulations
We can assist in preparation of safety data sheets that comply with Australia and other countries as per GHS regulations for hazardous chemicals. We can author large number of SDS in short amount of time using our expert tools to create SDS. Where required we can assist companies establish internal systems for ongoing SDS management and train staff if needed.
We also specialise in New Zealand regulations and can assist with harmonised launches for Australia and New Zealand. We specialise in New Zealand EPA, Medsafe, ACVM and MPI regulations.