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Pan Pharmaceuticals: Questions & answers for sponsors of 'Australian-supplied' and/or 'export-only' medicines

Suspension of Pan Pharmaceuticals Limited's manufacturing licence

4 May 2003

1. Suspension of Pan Pharmaceuticals Limited's manufacturing licence

Q. Who are Pan Pharmaceuticals Limited?

A: Pan Pharmaceuticals Limited is Australia's largest contract manufacturer of complementary medicines such as herbal, vitamin, mineral and nutritional supplements. They also manufacture some over-the-counter (OTC) medicines including some pain relievers, cold and flu preparations and other OTC medicines.

Medicines manufactured by Pan Pharmaceuticals Limited are widely available in Australia as well as exported to overseas countries.

Products manufactured by Pan Pharmaceuticals Limited may be supplied directly by the Company or supplied to other companies which market the products under their own brands.

Q. What regulatory action has been taken against Pan Pharmaceuticals Limited?

A: Pan Pharmaceuticals Limited's licence to manufacture medicines has been suspended from 28 April 2003 for six months to urgently address quality and safety concerns posed by manufacturing breaches.

Sponsors will not be able to use Pan Pharmaceuticals Limited as a manufacturer while the company's manufacturing licence is suspended.

Q. Why has regulatory action been taken against Pan Pharmaceuticals Limited?

A: Inspections by the Therapeutic Goods Administration (TGA) of Pan Pharmaceutical Limited's manufacturing premises have found evidence of widespread and serious deficiencies in the company's manufacturing and quality control procedures. The company's manufacturing licence has therefore been suspended for 6 months from 28 April so that quality and safety concerns posed by the manufacturing breaches can be urgently addressed.

The TGA has a responsibility to protect the health of all Australians. As Australia's national regulator for medicines, the TGA is obligated to take action where there is a concern in relation to the quality, safety or effectiveness of medicines. This applies to medicines for supply in Australia and medicines exported from Australia.

The action by the TGA follows investigation of Pan Pharmaceuticals Limited after serious and life-threatening adverse reactions were experienced by people who took an over-the-counter travel sickness tablet (Travacalm Original) manufactured by Pan Pharmaceuticals Limited. There have been 87 adverse drug reactions to Travacalm reported to the TGA, 19 of which were serious enough to require hospital treatment. As a result, a consumer level recall of two Travacalm products (Travacalm Original and Travacalm HO), both made by Pan Pharmaceuticals Limited, was undertaken in January 2003.

Q. Why did it take so long for the TGA to respond to the breaches of manufacturing practices by Pan Pharmaceuticals Ltd?

A. The TGA became aware of potential manufacturing problems at Pan Pharmaceuticals Ltd in mid-January this year when serious adverse events associated with the travel sickness tablets Travacalm (manufactured by Pan Pharmaceuticals Ltd) were reported. The TGA took immediate action to remove the Travacalm products from the market and to suspend the ability of Pan Pharmaceuticals Ltd to continue to make products of that type.

The TGA then commenced further audits of the company to investigate whether the problems that existed with the manufacturing of Travacalm could be problems of a more general nature with the company's manufacturing processes. These audits revealed widespread additional problems with the company's manufacturing procedures including systematic and deliberate manipulation of quality control test data and other serious breaches of good manufacturing practice (GMP).

An unannounced audit of all of Pan Pharmaceuticals Ltd's operations was therefore planned to take place in the week of 24 February 2003. Due to objections by the company, TGA officers were only able to examine limited records on that occasion and the audit was limited to two days, 24 and 25 February. However, they took away with them a range of data which after extensive analysis, highlighted areas of concern to be targeted for careful investigation in a further audit. Another unannounced audit was completed over the period 7 - 14 April 2003. Thereafter, the auditors prepared a detailed report of the audit and its findings. By the very nature of the extent and systemic reach of the problems identified during the audits, preparation of the report required painstakingly attention to detail and was a time consuming process.

The audit report was considered by an Expert Advisory Group established to advise the TGA on the health and safety risks posed to consumers of products manufactured by Pan Pharmaceuticals Ltd.

The Expert Group met on 23 April 2003, and recommended to the TGA that the manufacturing breaches were of such consequence that it was considered that ongoing availability of Pan Pharmaceuticals Ltd's products represented very serious risks to the community. They advised that the risks would increase over time, and that they could be realised at any time. Following this advice, and other matters raised by the audit reports, the TGA moved to immediately suspend the manufacturing licence of Pan Pharmaceuticals Ltd and commence a recall of all products made by the company since 1 May 2002 (when the company's last satisfactory GMP audit had been completed).

The TGA is confident that the whole audit, evaluation and decision-making process has been completed within in a minimum timeframe necessary to enable a proper audit and a considered decision to be made. Elapsed time between the first unannounced audit and the TGA's final decision has been consumed by investigations, systematic and careful analysis of findings, the seeking of expert advice and finally, a proper consideration of relevant matters before a decision was made on 28 April 2003. Any less care leading up to a decision of this regulatory magnitude may not have been defensible.

Q. What medicines are affected by the TGA's regulatory action against Pan Pharmaceuticals Limited?

A: The medicines of concern include all batches of all medicines manufactured by Pan Pharmaceuticals Limited from 1 May 2002.

The latest date that the TGA can be assured that Pan Pharmaceuticals Limited complied with the requirements of the Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products was 30 April 2002. This is the date of the last acceptable TGA GMP audit of Pan Pharmaceuticals Limited's manufacturing processes. Accordingly, the TGA cannot be assured that medicines manufactured after that time by Pan Pharmaceuticals Limited are not subject to breaches of the standards of GMP, including critical deficiencies in manufacturing processes.

The product range and number of batches that have been manufactured by Pan Pharmaceuticals Limited since 1 May 2002 are still being determined by the TGA.

Sponsors cannot use Pan Pharmaceuticals Limited as a nominated manufacturer for their products while Pan Pharmaceuticals Limited's licence is suspended.

A single batch of the antidepressant medicine, Allegron 25 mg is being recalled as part of the recall of medicines manufactured by Pan Pharmaceutical Limited. The recall applies only to this prescription medicine, and only to 178 packs of a single batch of Allegron that was released to pharmacists in parts of NSW and Queensland. Details of the batch number and action required by patients who have had medicines prescribed from this batch.

No safety problems have been identified with any other prescription medicines available in Australia. Australians may continue to take their prescription medicines.

Q. How long has Pan Pharmaceuticals Limited's licence to manufacture medicines been suspended?

A: Pan Pharmaceuticals Limited's licence to manufacture medicines has been suspended from 28 April 2003 for six months to address quality and safety concerns posed by manufacturing breaches.

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2. Recall of 'Australian-supplied' medicines

Q. How can I determine if my products are affected?

A: Your products are affected if they are listed or registered on the Australian Register of Therapeutic Goods (ARTG) and include Pan Pharmaceuticals Limited as a nominated manufacturer.

Medicines included on the Australian Register of Therapeutic Goods (ARTG) show all manufacturers nominated by the sponsor. Although Pan Pharmaceuticals Limited may have been nominated as a possible manufacturer from 1 May 2002, the product, or some batches of the product, may not have been actually manufactured by Pan since this date. Sometimes, alternative manufacturers are nominated and used by sponsors to make their products.

Q. Why are medicines manufactured by Pan Pharmaceuticals Limited from 1 May 2002 affected by the TGA's regulatory action?

A: The latest date that the TGA can be assured that Pan Pharmaceuticals Limited complied with the requirements of the Australian Code of Good Manufacturing Practice (GMP) for Medicinal Products was 30 April 2002. This is the date of the last acceptable TGA GMP audit of Pan Pharmaceuticals Limited's manufacturing processes. Accordingly, the TGA cannot be assured that medicines manufactured after that time by Pan Pharmaceuticals Limited are not subject to breaches of the standards of GMP, including critical deficiencies in manufacturing processes.

Q. None of my products have been manufactured by Pan Pharmaceuticals Limited; what do I have to do?

A: Even though you have not had any products manufactured by Pan Pharmaceuticals Limited, you should check your records to determine whether you have nominated Pan Pharmaceuticals Limited as a manufacturer for any of your products as further action may be required (see next question).

If none of your products have Pan Pharmaceuticals Limited nominated as a manufacturer in the Australian Register of Therapeutic Goods (ARTG) then no action is required.

Q. My product has Pan Pharmaceuticals Limited nominated as a manufacturer; what do I have to do now?

A: You should have received information and a Product Questionnaire that was faxed and mailed to you by the TGA on Monday, 28 April. You need to complete the Product Questionnaire and email or fax it back to the TGA by Close Of Business, Wednesday, 30 April.

If you nominated Pan Pharmaceuticals Limited as a manufacturer for any of your products from 1 May 2002 and you did not receive the information and Product Questionnaire package, please contact the TGA on (02) 6232 8805.

Records of medicines included in the Australian Register of Therapeutic Goods (ARTG) show all manufacturers nominated by the sponsor. Although Pan Pharmaceuticals Limited may have been nominated as a possible manufacturer for your products from 1 May 2002, the product(s), or all batches of the product(s), may not have been actually manufactured by Pan since this date. Sometimes, alternative manufacturers are nominated and used by sponsors to make their products.

Check your records to determine if you have products that have actually been manufactured by Pan Pharmaceuticals Limited from 1 May 2002.

The Product Questionnaire, together with instructions for submitting the required information to the TGA, is available on this website.

Q. My product has been manufactured by Pan Pharmaceuticals Limited from 1 May 2002, what do I have to do now?

A: 1. You must cease supply of the product manufactured by Pan Pharmaceuticals Limited from 1 May 2002; and

2. You must complete the Product Questionnaire in the information package that was faxed and mailed to you by the TGA on Monday, 28 April. The completed Product Questionnaire must be returned (email or fax) to the TGA by Close Of Business, Wednesday, 30 April.

The Product Questionnaire, together with instructions for submitting the required information to the TGA, is available on this website.

Q. Are all batches of all products manufactured by Pan Pharmaceuticals Limited from 1 May 2002 subject to recall?

A: Yes. Given the problems identified with Pan Pharmaceuticals Ltd and the seriousness of the quality and safety concerns associated with products manufactured by Pan Pharmaceuticals Limited, you are strongly encouraged to immediately initiate a voluntary safety related consumer level recall of all batches of product manufactured by Pan Pharmaceuticals Ltd from 1 May 2002.

You should be aware that any steps taken to recover goods are to be performed in accordance with the Uniform Recall Procedure for Therapeutic Goods 2001 Edition (URPTG). A specific information package for sponsors covering the voluntary recall of products manufactured by Pan Pharmaceuticals Limited, has been prepared by the TGA to assist in planning these recalls. The package, which includes specific instructions covering the recall letter and the need for press advertising and the current URPTG, can be obtained from the TGA website, or copies of the information package obtained by contacting the TGA Recalls Section on 02 6232 8554.

To assist those sponsors who participate in a voluntary recall, the TGA will be issuing public notices in line with the requirements of the URPTG to alert consumers to the risk of using products manufactured by Pan Pharmaceuticals Limited from 1 May 2002.

Return the Product Questionnaire by Close of Business (COB) Wednesday 30 April 2003, indicating that you will be undertaking a voluntary safety related consumer level recall, the TGA will automatically include you in any notices required by the URPTG thereby removing the requirement for you to conduct this advertising at your own expense.

If the product is still warehoused under your control, it is technically not subject to recall, but it is unlawful to supply/export the product.

Q. Why are products manufactured by Pan Pharmaceuticals Limited from 1 May 2002 subject to recall to consumer level?

A: The TGA considers that this action is necessary to prevent imminent risk of death, serious illness or serious injury associated with the use of these medicines. In making this decision, the TGA considered two Good Manufacturing Practice (GMP) audit reports on Pan Pharmaceuticals Ltd prepared by the TGA this month as well as the opinion and advice of an Expert Advisory Group established to advise the TGA on the impact of, and risks associated with, the manufacturing deficiencies on products manufactured by Pan Pharmaceuticals Limited when used by the public.

Q. What if I do not voluntarily recall all batches of product that were manufactured by Pan Pharmaceuticals Limited from 1 May 2002?

A: The TGA will move to take further regulatory action against you, as the sponsor.

Q. What information do I need to provide to the TGA if I wish to nominate additional manufacturers for my product?

A: If you wish to nominate an additional manufacturer(s) for your product, it is a condition of listing/registration that you notify the TGA of this, and you are required to reflect this change in the Australian Register of Therapeutic Goods (ARTG) record for your products.

Applications to vary manufacturing information for medicines listed on the ARTG for supply in Australia can be found in the document titled 'Changes to Medicines Listed on the ARTG'. Applications to vary manufacturing information for medicines registered on the ARTG for supply in Australia can be found on this website.

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3. 'Export-only' medicines

Q. Will I be required to recall 'export only' products manufactured by Pan Pharmaceuticals Limited from 1 May 2002?

A: 1. No. The TGA will not require product manufactured by Pan Pharmaceuticals Limited from 1 May 2002 to be recalled from overseas countries.

2. If the product is still warehoused under your control, it is technically not subject to recall, but it is unlawful to supply/export the product.

Q. What do I do with my 'export only' product manufactured by Pan Pharmaceuticals Limited is still warehoused under my control?

A: You are advised to arrange for the appropriate disposal/destruction of these goods, in accordance with relevant Commonwealth, State or Territory 'hazardous waste' legislation.

Q. As product already exported does not need to be recalled, what action is being taken to advise overseas authorities and consumers of the Australian action?

A: The TGA recognises the logistical difficulties associated with conducting overseas recall action. However, the TGA will be notifying all overseas health authorities whose countries have received Pan-manufactured 'export-only' products manufactured since 1 May 2002. To assist in this process, the TGA will be seeking the co-operation of sponsors to provide certain information about their exported products (further details below).

Q. What if I do not cease supply of my 'export only' product manufactured by Pan Pharmaceuticals Limited from 1 May 2002, or provide the information requested by the TGA on 28 April 2003?

A: The TGA will move to take further regulatory action against you, as the sponsor.

Q. When will I be able to re-commence supply/export.

A: Once you have provided the appropriate notification to the TGA that -

  1. supply of all existing product manufactured by Pan Pharmaceuticals Limited from 1 May 2002 has ceased; and
  2. the product has been produced by a licensed manufacturer; and
  3. you have provided the contact details for your overseas suppliers/importers.

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4. General questions

Q. Can I get my product analysed and avoid recall?

A: No. Without the manufacture of a medicine complying with the Australian Code of Good Manufacturing Practice for Medicinal Products, the quality and safety of a product cannot be adequately assured by analysis of the finished product alone.

Q. How do I know which products manufactured by Pan Pharmaceuticals Limited, aside from my products, have already been recalled?

A: Recalled products will be listed on this website and will also be included in major metropolitan newspapers.

Question Why have I received more than one letter from the TGA?

A: The TGA is contacting sponsors of products affected by the decision to suspend Pan Pharmaceuticals Limited's manufacturing licence under three separate categories:

  • Category 1 is where Pan is both the sole manufacturer and sponsor.
  • Category 2 is where Pan is the sole manufacturer but not the sponsor
  • Category 3 is where Pan is one of several nominated manufacturers but not the sponsor

Category 1 letters have only been sent to Pan Pharmaceuticals Limited.

If your product is included in Categories 2 or 3, you may receive up to 4 letters:

  • Letter 1: for Category 2 products where products are destined for the Australian market.
  • Letter 2: for Category 3 products where products are destined for the Australian market.
  • Letter 3: for Category 2 products where products are for export only.
  • Letter 4: for Category 3 products where products are for export only.

Letters applying to each Category are identified by a number in the centre of the first page (eg Letter 1).

Q. Where can I obtain further information?

A: Further information can be found on this website (Pan Pharmaceuticals Limited - regulatory action and product recall information) or by phoning the TGA's Sponsor Call Centre on 02 6232 8805 (hours 8.30am - 7.00pm EST, Monday - Friday).

Q. What is the frequency of GMP audits of manufacturers?

A. TGA's GMP audit program is based on an overall average re-audit frequency of 24 months. Risk management principles are used to determine the actual re-audit frequency for each manufacturer. This is based on product risk category and GMP compliance history and as a result the actual re-audit frequency may vary from 12 to 36 months. If necessary the TGA can also conduct GMP audits at any time to follow up an event that may reflect on GMP compliance, e.g. product recall.

The re-audit frequency adopted by the TGA is consistent with international best practice and is comparable with that adopted by equivalent regulators such as Canada, European countries including the UK, and Singapore.

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