Contract manufacturing is the core business of GMP Pharmaceuticals. GMP has over ten years experience serving the health food industry worldwide.

GMP Pharmaceuticals has three TGA/GMP licensed factories in Australia, New Zealand and China. GMP has the facilities to manufacture soft gel and hard shell capsules, coated and uncoated tablets, powders, liquids, creams and ointments.

GMP is the only contract manufacturer in Australia or New Zealand with three TGA/GMP licensed factories. Three factories in three different countries allows GMP Pharmaceuticals to offer flexibility on "Country of Origin", delivery time, freight cost, market approach, regulatory compliance and cost.

GMP Pharmaceuticals has the facilities and equipment to pack products in almost any form. Packaging options include bottles, jars, steel cans, vials, blisters (aluminium/aluminium or aluminium/pvdc), tubes and sachets. GMP Pharmaceuticals has close relationships with many major packaging material manufacturers and suppliers worldwide. This extensive packing supplier network allows GMP to meet clients’ specific needs for new and existing products.

Three TGA and GMP licensed factories also offers more flexibility and cost-saving options for packing product closer to the market, quicker delivery and regulatory compliance.

GMP Pharmaceuticals has research and development laboratories in Australia, New Zealand and China. At these labs, highly qualified and experienced teams are not only familiar with the latest technical and regulatory issues but they also have a deep understanding of market trends, especially in the fast growing East Asian markets. With support from GMP Pharmaceuticals advanced laboratories, GMP staff can set up all documentation including formulations, specifications, testing methods, and stability testing reports. These reports can be used for product registration, listing and product market launches.

Most dietary supplement products are classified as complementary medicines in Australia. Products must be registered or listed with the Australian Therapeutic Goods Administration (TGA) before they are introduced into the Australian market. GMP Pharmaceuticals regulatory team has extensive experience assisting clients with all issues related to the registration and listing processes.

Other countries also require listing or registration with their regulatory authority before introducing the product into their markets. GMP Pharmaceuticals has strong regulatory expertise, especially in East Asian countries.

The GMP regulatory team can assist clients in preparing for these processes or GMP can handle the entire process on the client’s behalf.

Stability testing is now required by most government agencies that regulate complementary medicines and medicinal dietary supplements. Stability testing requires the product to be stored for years so this process is very time consuming.

Stability studies (based on an acceptable potency test) are required to establish the validity of the expiry date that appears on the product package. In order to estimate stability to determine a provisional expiry date, a new product may be subjected to accelerated stability tests, for example incubating at 37°C for 1 week for each year of dating. Such estimates must be confirmed by periodic real-time potency tests on at least three different batches throughout the period of time indicated by the expiry date, and 3–6 months beyond.

Testing on products containing viable organisms is done at the time of release and at the approximate expiry date until a statistically valid record has been established. Stability testing provides the opportunity to test for residual moisture and for other important parameters, such as the stability of adjuvant emulsions.

GMP Pharmaceuticals has set up special laboratories and organised teams in New Zealand and China to conduct professional and efficient stability testing. These teams ensure that all tests meet the technical and regulatory requirements.

Top quality product packaging is critical to the success of your product in today’s competitive market place.

GMP Pharmaceuticals has close relationships with many major packaging material manufacturers and suppliers worldwide. This extensive packing supplier network allows GMP to meet clients' specific needs for new and existing products. Through this network, GMP is able to source almost any packaging form including bottles, jars, steel cans, vials, blisters (aluminium/aluminium or aluminium/pvdc), tubes and sachets in almost every shape, size and material available.

Sourcing pure ingredients is essential to manufacturing premium quality pharmaceuticals.

Through offices in Sydney, Auckland, Beijing and Hong Kong, GMP Pharmaceuticals has built an international network of highly reputable raw material suppliers.

Australia and New Zealand are producing an increasing number of popular and unique ingredients for the world dietary supplement market. GMP Pharmaceuticals is supported by many local raw material producers. GMP factory locations in Australia and New Zealand gives GMP an advantage in sourcing genuine Australian and New Zealand raw materials.

Under GMP Pharmaceuticals standard procedures, all suppliers and manufacturers must be inspected and evaluated before becoming an approved supplier. All material must also be tested prior to being released for processing or supplied to clients.

GMP is your one stop Pharmaceutical manufacturing shop. That means we do everything from having your product professionally manufactured through to a good-looking product on the shelf that will inspire customers to buy.

This means we can help with your label design, box design and even point of sale design. We work harder for your success by doing everything possible to ensure your product sells more.

Great graphic design jumps out at consumers and lands right in their shopping basket.

Call GMP today to ask about how we can help you with your graphic design.

Export Certificate: Click Here


For Details Please Contact:

Australia:
Please contact:
Tel:61-2-9636 1111
Email: info@gmp.com.au
New Zealand:
Please contact:
John Lee
Tel: +64 9 272 1111
Mob: +64 21-686-863
Email: john@gmp.net.nz

Working closely with Austrade and the regulatory laws of the lands you wish to export to, GMP can offer assistance with the paperwork required for each country and also advise on what products are allowed in each one and what their particular testing requirements are.

For example GMP knows and understands how to make products so that they pass each country’s very different regulatory standards.

The technical documents required by regulatory bodies can be extremely difficult to source, time consuming to prepare and hard to understand unless you work with them every day.

Let GMP Pharmaceuticals take the hassle out of compiling technical documents so you can concentrate on what you do best, selling manufactured complementary healthcare products.

Every country has different laws, regulations and requirements. At GMP we work harder for your success by helping you understand the requirements of each country to which you export and completing the relevant documents on your behalf.

As a GMP manufacturer, GMP Pharmaceuticals is able to supply a FREE SALE CERTIFICATE (where applicable) to goods manufactured by us, which clearly states that the product manufactured is compliant, safe and legally allowed to be sold.

At GMP Pharmaceuticals we work harder for your success by saving you time and money.

In some cases a Pre-clearance of goods is needed to reach those super tight deadlines we all work towards. Your GMP-manufactured products come with the option of a Pre-clearance certificate.

Health Food Registration Process

Health food are commonly know as functional foods or dietary supplements. The definition of health food in China is “food with special health functions”, meaning it is consumed in food form and it adjusts the body functioning but does not cure diseases.
Based on this definition health food must have three properties:

   • food properties
   • functional properties
   • non-medicinal properties

Besides health foods, nutritional supplement products such as vitamins and minerals must also apply for a variety of licences, including a health food license and a license for making health claims.

Producing, selling or importing any product or nutritional supplement with health function claims without approval from the State Food and Drug Administration (SFDA) is prohibited.

Health Food Registration Application Procedure

To register a product as a health food, it must be tested and a variety of application materials must be arranged. After these materials are all filed final judgment will be made by the relevant regulatory body. The below outline shows the steps in the process.

1. Importer or Agent

   • Fills out application forms
   • Provides additional documentation
   • Provides samples

2. The Health Food Judgment Committee, Ministry of Health - Performs a variety of tests on the product including:

   • Hygienic test
   • Stability test
   • Safety test
   • Functional test

3. Institute of Food Safety Control and Inspection, Ministry of Health – Issues a judgment based on the application and the above tests.

4. State Food and Drug Administration – The judgment is reviewed by an administrative judge. If the administrative judge agrees with the judgment of the Institute of Food Safety Control and Inspection judge then an import permit and free sale certificate will be awarded.

Frequently Asked Questions

1. Which product categories must apply for health food registration?

Health food can commonly be called “functional food” or “dietary supplement". The definition of health food in China is “food with special health functions”, meaning it is consumed in food form and it adjusts the body’s function but does not cure diseases.

Based on this definition health food must have three properties:
   • food properties
   • functional properties
   • non-medicinal properties
Besides health foods, nutritional supplement products such as vitamins and minerals must also apply for a variety of licences, including a health food license and a license for making health claims.

Producing, selling or importing any product or nutritional supplement with health function claims without approval from the State Food and Drug Administration (SFDA) is prohibited.

2. Which health claims can be made on health food products in China?

The following health claims are accepted by the State Food and Drug Administration:

1. Enhancing Immune System
2. Assisting Blood Lipid Reduction**
3. Assisting Blood Sugar Reduction**
4. Antioxidant**
5. Assisting Memory Improvement**
6. Alleviating Eye Fatigue*
7. Alleviating Lead Excretion**
8. Clearing the Throat**
9. Assisting Blood Pressure Reduction**
10. Sleep Improvement
11. Facilitating Milk Secretion**
12. Alleviating Physical Fatigue#
13. Enhancing Endurance
14. Assisting Irradiation Hazard Protection
15. Weight Control**#
16. Improving Child Growth**
17. Increasing Bone Density
18. Improving Nutritional Anaemia**
19. Assisting Protection Against Chemical Injury of the Liver
20. Eliminating Acne*
21. Eliminating Skin Chloasma*
22. Improving Skin Water Content*
23. Improving Skin Oil Content*
24. Regulating Gastrointestinal Tract Flora**
25. Facilitating Digestion**
26. Facilitating Excretion of Faeces**
27. Assisting the Protection of Gastric Mucosa**

**Must prove claim though tests on humans and animals.
* Must prove claim though tests on humans.
# Must prove claim though tests for addiction.

3. What materials are necessary for health food registration?

The following materials are necessary for health food registration:

1)Health Food Registration Application Form.
2) Copy of the applicant’s Business License.
3) Materials proving that the common name of the health food for application and registration is different from the name of any drugs already approved and registered.This information is obtained though a search of the State Food and Drug Administration Bureau database.
4) Letter of Guarantee stating that the application does not infringe upon any patents.
5) If the trademark is registered, the applicant must provide proof of the trademark.
6) Product R&D Report, including a list of research and development on the product as well as the function selection and anticipated effect.
7)Product formula including both raw and supplementary materials as well as the formula basis; origin and usage basis of both raw and supplementary materials.
8) Information on the effective component/symbolic component, content, and testing methods for the effective component/symbolic component.
9) Diagram of production method including detailed explanations and research materials.
10) Product quality standards and explanations for these standards, including the quality standards for raw and supplementary materials.
11) Packing material category, name, quality standard and safety information on material.
12) Test Report and related materials issued by the national product testing authority.
13) Materials issued by national authority in the country of production proving that the product manufacturer conforms to the national production quality management standard.
14) If registration is applied for by a representative office of an Australian or New Zealand company in China, a copy of the company's “Registration Certificate of Representative Office of Foreign Company Permanently Resided in China” must be provided. If the registration is applied for by an agent entrusted by an overseas manufacturer, the company must provide the original notarised Letter of Trust and Business License of the agent.
15) Certificate for products sold for more than one year in the country of production. This certificate must be notarised in the country of production and confirmed by Chinese Embassy or Consulate in the country of production.
16) Certification of relative standard by country of production or by an international organization.
17) Samples of packaging, label, and specification used by products in country of production.
18) Samples of the product.

The above declared information should be translated into Chinese and the original text should be included. Information in a foreign language may be attached for reference. The Chinese version should notarised in the country of origin. Quality standard of products applying for registration in Chinese shall meet the quality standard of Chinese health food.

4. What testing labs can be used for imported products?

Products must be tested by the Institute of Food Safety Control Inspection, Ministry of Health in China.

5. What are the imported heath food testing periods?

Stability and hygienic testing will last for at least 6 months. Toxicological testing purity periods last between 35 and 50 days. Most functional tests will last 35-50 days, but if a body test is used the periods will last longer.

6. How long is the period of judgment for the State Food and Drug Administration:

There will be a judgment meeting once a month held by State Food and Drug Administration (SFDA) once per month.

Regulations and Standards of Health Food in China

Health Food Import Licence applications must conform to the following regulations and standards:

1) Functional evaluation procedures and examination methods for health food:

Functional testing on animals or humans must be done based on the examination methods provided by Chinese government regulations. Whether the application product has function or not is determined by its evaluation procedure.

2) Toxicological testing procedures and methods for food safety:

Toxicological testing should be done based on this regulation. The product must be confirmed not to have acute, sub-acute or chronic hazards.

3) Food Hygiene Standards of China and General Requirements on Health Food Hygiene:

Laboratory testing must be done according to Chinese government regulations. Imported health food must comply with these requirements.

4) Regulations for health food labeling and General standard of China on food labeling:

The label and use introduction of the product must comply with these two regulations.

5) Technical evaluation rules for health food and rule for the application and acceptance for health food:

If applying for an Approved Code Number and Certificate of Health Food, the applicant must conform to the procedures provided by Chinese regulations.

6) Good Manufacturing Practices for health food companies:

The health food enterprise must meet all requirements of Good Manufacturing Practices.

Complete Health Food Registration Service

Window of AUSNZ can assist you with the preparation and follow up for your health food registration application. The Window of AUSNZ team can assist with all aspects of this application including testing, the actual application form and translation of the relevant materials. This process includes following the application through the entire process to the application judgement including the health food license and import permit.

Food Registration Process

The dietary supplement market in China is divided into two parts, Health Food and Food for Special Dietary Uses. The regulations for Health Food products are in the Health Food Registration section above.

Food products in the categories of ordinary food or food for special dietary uses must abide by the Rules and Regulations of the Import-Export Commodity Inspection Laws and either the Food Labelling General Rules Concerning Pre-packed Foods for Special Dietary Uses or the Food Labelling General Rules Concerning Pre-packed Foods depending on the category of the product.

Steps in the Food Registration Process

If all related national regulations are met, there is no national level product registration process.

Provincial Import-Export Commodity Inspection Bureau conducts a food label audit to ensure the label meets the provincial requirements.

Provincial Import-Export Commodity Inspection Bureau executes a variety of quality tests on the product.

If the product passes all tests, a food registration permit is awarded.

Cosmetics Registration Process

Imported Cosmetic Application Procedure

Imported cosmetics are categorized into imported general cosmetics and imported cosmetics for special usage. All imported cosmetics must get approval from the Ministry of Health. There will be four judgment meetings held by the cosmetic safety judgment committee of Ministry of Health each year.

The imported cosmetic application procedure includes testing, preparing application materials and applying for final judgment as well as any additional steps that may be necessary for your specific application. According to the Imported Cosmetic Supervisory and Test Management Regulation, the applicant must have a Hygienic Permit License. The applicant must also have a Chinese Label of Import Cosmetic Permit License. The applicant may apply for testing at The Test and Quarantine Department after receiving the Hygienic Permit License and the Chinese Label of Import Cosmetic Permit License.

Imported Cosmetics Application Materials

Imported cosmetic application materials contain one original document and thirteen copies of each of the following:

1. Initial materials

   • Product formula
   • Cosmetics in the category of cosmetics for special use must provide an active ingredient list, usage basis and the testing methods for the active ingredients.
   • Samples for testing

2. Materials needed before the judgment

   • Application form
   • Manufacturing processing sketch and explanation
   • Product quality standard
   • Sample of product packaging including a copy of the label
   • Product explanation
   • Power of attorney authorizing that an agent apply on behalf of the applicant
   • The manufacture and free sale certificate issued by the country of manufacture
   • Three product samples

Steps in the Imported Cosmetic Registration Process

1. Australian or New Zealand Company provides documents to Window of AUSNZ

   • Power of Attorney
   • Product Formula
   • Overview of Product

2. Australian or New Zealand company’s Attorney

   • Fills out the sample testing application
   • Provides other application materials

3. Ministry of Health, Appointed Testing Institution

   • Material Test
   • Hygienic Test
   • Issue safety report

4. Ministry of Health, relevant Health Food Application Office – The relevant health food application office at the Ministry of Health will request any additional necessary materials at this time.

5. Cosmetic Hygienic Safety Judgment Committee – The Cosmetic Hygienic Safety Judgment Committee gives a final judgment on the product.

6. Ministry of Health – After the product is judged to meet the requirements, the Ministry of Health will issue the necessary product approval permits.

Imported Cosmetics Application Services

1. Window of AUSNZ can assist with applications for:

   • General cosmetics
   • Cosmetics for special usage

2. Application services include:

   • Full application processing for an import cosmetic application
   • Partial assistance with the import cosmetic application process
   • Technique consultation services
   • Trademark registration
   • Label consultation and registration

Due to the current reformation of these regulations in China, this document is for reference only.

Because GMP Pharmaceuticals manufactures products under GMP guidelines, we are also able to provide the certificate that assures compliance with good manufacturing processes.

Dairy Products easily lose their integrity and viability if not stored or manufactured properly. GMP understands this, therefor when we manufacture your dairy products we are certified to issue you with Dairy Export Registration papers.

China is fast becoming one of the most important markets in the world today. Understanding China and the policies of the government is crucial to doing business with China.

GMP has an office in Beijing and understands China, the people and regulations better than any Pharmaceutical manufacturing company in Australia and New Zealand.

Regulations and Standards of Health Food in China

Health Food Import Licence applications must conform to the following regulations and standards:

1) Functional evaluation procedures and examination methods for health food:

Functional testing on animals or humans must be done based on the examination methods provided by Chinese government regulations. Whether the application product has function or not is determined by its evaluation procedure.

2) Toxicological testing procedures and methods for food safety:

Toxicological testing should be done based on this regulation. The product must be confirmed not to have acute, sub-acute or chronic hazards.

3) Food Hygiene Standards of China and General Requirements on Health Food Hygiene:

Laboratory testing must be done according to Chinese government regulations. Imported health food must comply with these requirements.

4) Regulations for health food labeling and General standard of China on food labeling:

The label and use introduction of the product must comply with these two regulations.

5) Technical evaluation rules for health food and rule for the application and acceptance for health food:

If applying for an Approved Code Number and Certificate of Health Food, the applicant must conform to the procedures provided by Chinese regulations.

6) Good Manufacturing Practices for health food companies:

The health food enterprise must meet all requirements of Good Manufacturing Practices.

The Australia New Zealand Health Care Association (ANZHCA) is an industry association which provides substantial benefits to its members through a wide variety of educational, networking and export promotion activities. The objective of ANZHCA is to promote exports by combining high quality products with a wealth of exporting experience.

ANZHCA will provide an interactive network through which members will be able to take advantage of group related export activities that may not be cost effective for individual members. This network will act as a resource for exporters in navigating various business and regulatory environments in different export markets. The Australia New Zealand Health Care Association is the only industry association in Australia or New Zealand focused on facilitating the export of natural health care products, such as complementary medicines, dietary supplements, functional foods and skincare and cosmetic products of Australian and New Zealand origin. An important component of the Australia New Zealand Health Care Association is the “AUNEW Export Group”.

Australia and New Zealand have similar cultures and clean, natural images around the world. The “Trans-Tasman Joint Agency” has made Australia and New Zealand the most strict regulatory environments anywhere in the world for complementary medicines, health food, dietary supplements and skincare and cosmetics products.

Compared with selling in Australia and New Zealand, exporting products especially to the East Asia market face a range of difficult challenges. These challenges include cultural and language barriers, export quotas, legal issues, marketing challenges and regulatory issues. Rather than potential exporters facing these challenges individually, the AUNEW Export Group takes the first step by setting up a platform for Australian and New Zealand natural health care product exporters. The AUNEW Export Group will maximize exporter returns by consolidating resources especially in the high growth Asian markets.

Australia has some of the most stringent testing and checking procedures in the world when it comes to pharmaceutical manufacturing. Products manufactured by GMP Pharmaceuticals may be eligible to carry the Australian Made, Australian Grown logo. Please advise us when discussing your requirements, and we will provide you with a licence application to use the logo.

The Australian Made logo on a pharmaceutical product proves the product was manufactured in Australia to one of the highest standards in the world.

New Zealand therapeutic product manufacturing regulations are some of the most stringent in the world, similar to the regulations in Australia. New Zealand like Australia is known for its fresh clean non-polluted air and environment.

As a member of the New Zealand Made Corporation, all products made by GMP Pharmaceuticals in New Zealand are able to carry this logo.

The New Zealand Made logo on a pharmaceutical product proves the product was manufactured in New Zealand to one of the highest standards in the world.

The escalating demand for natural health products in China has resulted in a market that has already reached US$625 million and is forecast by some to double. It is recognized that while there is great opportunity in this burgeoning market, there are also many pitfalls and challenges, counterfeiting is regarded as one of the most significant issues.

The Australia New Zealand Export Group (AUNEW) has been established under the Australia New Zealand Health Care Association (ANZHCA) and the China Health Care Association (CHCA) with close ties to the China Government, to facilitate export trade from Australia and New Zealand to China.

Using latest technology, AUNEW has introduced an anti-counterfeiting label that will provide consumers in China a mechanism for confirming that the product they have purchased is genuine. Two advanced technologies have made the label almost impossible to counterfeit and they are very user-friendly (including manufacturer friendly, consumer friendly and surveillance-friendly) and also come at a reasonable cost.

The first technology features a unique Anti-Counterfeiting Code (AC code), which is approximately 18 digits. The technique involves random code selection. Labels off the production line are instantly referenced into Identification Database and the AC code will be validated via a popular portal website www.aunew.com or telephone number 95105815.

The second is Labeling Fragment Assembling Technique. The label is made of numerous fragments that cannot be entirely torn off so it cannot be re-used or re-cycled by a potential counterfeiter.

Aunew Anti-Counterfeiting Label (AACL) is a powerful tool to protect the image of Australian and New Zealand products. It is also a co-regulatory mechanism involving industry, government, consumers and media providing greater consumer confidence in products from Australia and New Zealand.

The problem of counterfeit products is a big issue in the pending Australia-China and China-New Zealand free trade agreements. AACL is currently the only powerful weapon available in the arena to fight against the counterfeiters.

For more information or applying to become a licensee, please visit: www.aunew.org.

Putting barcodes on your products can be a big problem if you do not understand how they work.

Many companies that use omni- directional barcode scanning (like your major supermarket chains) will not accept your product unless it is accompanied with a verification report from GS1 (formerly EAN).

GMP Pharmaceuticals knows and understands the requirements of barcoding and is available to assist with your needs as required.