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Produto: Medicamentos
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O Ponto Focal da Austrália respondeu o seguinte sobre exportação de Medicamentos:
Produto: Medicaments Humanos (HS 3004):
The Therapeutic Goods Administration (TGA), located within the Department of Health and Ageing, is responsible for the regulation of medicines in Australia. Most products for which therapeutic claims are made must be listed or registered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. There are specific requirements for prescription medicines, non-prescription medicines and complementary medicines. For detailed information, please consult the website of the TGA:
The Therapeutic Goods Administration (TGA):
www.tga.gov.au/import/index.htm
or email the TGA information service:
tga-information-officer@health.gov.au
Produto: Veterinary medicines (HS 3004.90):
In most cases, before agricultural and veterinary chemical products can be sold, supplied, distributed or used in Australia, they must be registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Veterinary chemical product' includes any substance administered or applied to an animal to: prevent, diagnose, cure or alleviate a disease, condition or pest infestation; cure or alleviate an injury; or modify the physiology.
It also includes: any substance that modifies the effect of another veterinary chemical product; vitamins, minerals and additives if they are used for any of the purposes mentioned above; allergenic substances, medicated blocks and licks, enzymes for animals, direct-fed microbial products and sheep branding substances, and stockfood non-active constituents unless listed in Agvet Code Stockfood and Non-active constituent order.
Non-medicated licks and blocks, stockfoods and stockfood additives (feed supplements) must be registered if they carry claims about therapeutic effect, performance or productivity enhancement.
For information about the registration process, including application forms, please consult the APVMA website:
Australian Pesticides and Veterinary Medicines Authority (APVMA): Registering Products:
www.apvma.gov.au/registration/registering.shtml
Please note that for products manufactured overseas, the registrant needs to provide evidence of compliance with good manufacturing practice (GMP) at the time of registration. Acceptable evidence of GMP compliance might include: a current GMP certificate from an overseas agency or Australian agency recognised by the APVMA (eg US Food and Drug Administration where the manufacturer has been audited by them for the purposes of supplying to the USA); or a satisfactory audit report from an auditor from an overseas agency recognised by the APVMA or otherwise assessed by APVMA as being competent, or an APVMA- authorised GMP auditor, confirming that the premises complies with a GMP Code recognised by the APVMA as comparable to the Australian GMP Code.
The APVMA will consider audit reports from: an APVMA-authorised GMP auditor from Australia (list available from APVMA website); a Therapeutic Goods Administration (TGA) auditor from Australia; an auditor from one of overseas competent authorities recognised by the APVMA (ie EU, USA, Canada NZ, or a member of PIC/S).
In certain circumstances, the APVMA may consider an audit report from an alternative quality assurance certifying body that is internationally recognised (eg SGS). However, agreement must be obtained from the APVMA's Quality Assurance and Compliance Section before the audit takes place.
Detailed information on GMP requirements, including a list of AMPVA-authorised GMP auditors, is available at:
Australian Pesticides and Veterinary Medicines Authority (APVMA): The Overseas GMP Scheme:
www.apvma.gov.au/qa/mls_overseas.shtml
For advice on import requirements for specific products, exporters are advised to contact the APVMA directly at: enquiryline@apvma.gov.au
Utilize a base de informações do Ponto Focal para saber sobre novas notificações e inscreva-se no Alerta Exportador!
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