AUSTRALIA
Medicines
In most cases Australian manufacturers
of medicines must hold a licence. To obtain a licence to manufacture medicines,
a manufacturer must demonstrate, during a factory audit, compliance with
manufacturing principles, which include the Australian Codes of Good
Manufacturing Practice (GMP).
Overseas manufacturers must demonstrate
that they meet similar standards before imported goods may be registered.
Many applications for registration or
listing of medicines on the Australian Register of Therapeutic Goods (ARTG) are
either delayed or rejected due to a lack of acceptable evidence of the standard
of manufacture of medicines. Sponsors are requested to obtain GMP clearance of
overseas manufacturers prior to submitting an application for registration,
listing or variation of a product.
GMP Certification may be accepted for
manufacturers in countries with which Australia has a mutual Recognition
Agreement. Only the original EU, & EFTA countries, Switzerland and Canada,
have these agreements with Australia. Manufacturers from newer EU countries,
New Zealand and USA must provide extensive documentation and undergo a
"desk audit". If acceptable GMP evidence cannot be obtained, and for
all other countries, an inspection by Australian auditors will be required.
All documentation required for
Manufacturing & GMP can be found on the TGA website, please see
"Useful Links" below.
Medical
Devices
Australian manufacturers of all classes
of medical devices, except Class 1, are required to undergo conformity
assessment of their manufacturing quality system by the TGA before the goods
are eligible for inclusion on the ARTG. Overseas manufacturers must either hold
acceptable CE Certification of their Quality System from a European Notified
Body or undergo conformity assessment by the TGA.
ADVANTAGE MPC can assist you with all
documentation, applications etc. required before TGA audit/conformity
assessment.
NEW
ZEALAND
ADVANTAGE MPC can provide a similar
service for New Zealand clients.
Getting
Started…
Advantage MPC can arrange to undertake
the following services for you:
- Assess overseas Certifications and
documentation
- Arrange for TGA Audits
- Carry out pre-assessment audits
- Assist with the preparation of
Site Master Files and Validation Master Plans
- Arrange applications for
Pre-Clearances of Overseas manufacturers (Medicines) or Manufacturer
Certification (Medical devices).
To get started, you need to refer to
the websites listed below and complete the Free Online Consultation Form.
Useful Links:
http://www.tga.gov.au/industry/manuf.htm
http://www.tga.gov.au/industry/manuf-overseas-medicines-gmp-clearance.htm
