Revised: 23 May 2013

Committees

Minutes of the 33rd meeting of the Medicines Classification Committee - 9 June 2005

Held on 9 July 2005 in the Medsafe Meeting Room, 18th Floor, Grand Plimmer Tower, Wellington. Commencing at 9:30am.

PRESENT

Dr S Jessamine (Chair)
Dr J Peckham
Dr S Ryder-Lewis
Mrs A Shirtcliffe
Ms N Gauld

Mrs C Smith (Secretary)

1. Welcome

The Chair welcomed members to the 33^rd meeting.

He informed members that the date for the implementation of the Joint Trans-Tasman Agency for the regulation of medicines and medical devices had been postponed until July 2006. As a consequence, the present Committee could meet several times more. He said that Medsafe might therefore decide to nominate a replacement for the Ministry member who had resigned the previous year.

With reference to the new scheduling process proposed for the Joint Agency, the Chair informed the Committee that the details were not yet ready to be looked at by members. He said that they would probably be part of a package of draft documents which would be put out shortly for consultation and that members would have an opportunity to consider the proposals and to comment if they wished.

2. Apologies

There were no apologies.

3. Confirmation of the minutes of the 32 ^nd meeting

The minutes of the 32^nd meeting were confirmed to be an accurate record of that meeting and were signed by the Chair.

4. Declaration of conflict of interests

Two potential conflicts of interest were declared by one of the members. These were discussed by the Committee. One of these related to consultation work carried out before the member had been appointed to the Committee. Full participation of the member in discussion relating to the relevant agenda item was not considered to pose any conflict of interest. However, the member was also currently involved on a consultancy basis for a pharmaceutical company for salbutamol products. Other members felt that the usage knowledge acquired by the member in the course of this activity might provide valuable to the Committee. It was therefore agreed that this member could provide information if requested by other members but would have no spontaneous input into the discussion on salbutamol and would not vote on the issue.

5. MATTERS ARISING from the 32 ^nd meeting

5.1 Zanamivir (Relenza)

Medsafe had sought comment about whether the sponsor company wished to make a submission for reclassification from prescription medicine to restricted medicine. The company confirmed that it was interested in making such a submission and would prepare a submission for consideration at the meeting to be held in the latter part of the year.

5.2 Orlistat

The Secretary confirmed that both the requirements sought by the Committee as conditions for the over-the-counter sale of orlistat had been agreed to. The company had agreed to change the indication for the product to an initial BMI greater than 30.

In addition, the Pharmacy Council had amended the Protocol for the Sale of Medicines for Chronic Conditions so that a face-to-face consultation was required before making an initial sale. This amendment had the advantage of applying, not only to orlistat, but also to any other over-the-counter medicines which were used to treat chronic conditions. It would prevent sale over the internet for any such medicines unless a personal interview had been conducted first.

During communication with the company following the previous meeting it had come to light that not all of the current approved indications for orlistat were suitable for OTC sale. Therefore the restricted medicine schedule entry would need to be worded more specifically in order to make the distinction between prescription medicines containing orlistat and those suitable for OTC sale.

The Committee agreed that Medsafe should reword the scheduling of orlistat in order to ensure that this distinction was implemented.

Recommendation

That the schedule entry for orlistat should be amended to reflect the intention that orlistat should be classified as a restricted medicine when only when indicated for weight control purposes

5.3 Porcine pancreatic enzymes

The Secretary reported that the change to prescription medicine for lower-strength porcine pancreatic enzymes had not proceeded in Australia. This was due to the risk of transmitting infection proving to be less than earlier stated. Therefore the change had not been implemented in New Zealand and any porcine products containing 20,000 BP units of lipase activity would continue to be available as general sale medicines.

The Committee agreed that the quality of general sale products could shortly be controlled by regulation under the Joint Agency. No further recommendation was required.

5.4 Mercury

The change to reduce the permitted exemption from prescription status for mercury from 10 milligrams per litre or per kilogram to 1 milligram per litre or per kilogram had been removed from the Gazette notice at the request of Weleda who had requested that its submission be reconsidered in the light of subsequent National Drugs and Poisons Schedule Committee (NDPSC) discussion. While the maximum weekly dose of the Weleda product was only 84 micrograms, which was less than the World Health Organisation's (WHO) provisional tolerable weekly intake of 0.3 milligrams per person per week, the concentration of the tablets exceeded the proposed cut-off point of 1 milligram per litre or per kilogram. Weleda requested that a statement be added to the exemption to permit the general exemption of l0 milligrams per litre or per kilogram to remain valid when a maximum weekly dose limit consistent with the WHO limit was applied to the pack size permitted for over-the-counter (OTC) sale. Weleda also suggested a possible pharmacy-only classification which might be applied to enable products to continue to be marketed over the counter.

Although the weekly limit proposed by Weleda was well within the weekly limit allowed by the WHO, the Committee was concerned about the long-term use of mercury. Members also felt that environmental issues should be taken into account in that some areas had higher residual mercury levels than others. Growing mercury content of fish was of particular concern.

The Committee was not happy to see mercury for internal use available at pharmacy-only level. However, members agreed that any product presented for sale as a pharmacy-only medicine would require a full safety evaluation. If such products were to be considered for sale at pharmacy-only level for other than external use, the Committee agreed it would require full safety and toxicity data as well as details about packaging and labelling and the way in which the product was intended to be used before it could consider whether or not the product was suitable for OTC sale.

The Committee agreed to stand by its earlier recommendation that the exemption from scheduling for internal use of mercury should be 1 milligram per litre or per kilogram in harmonisation with the Australian level set in Appendix G of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).

Recommendation

That the cut-off point for the exemption from scheduling for mercury should be changed from the standard exemption of 10 milligrams per litre or per kilogram to 1 milligram per litre or per kilogram.

6. Submissions for reclassification

6.1 Domperidone (Motilium, 10mg tablets, Janssen-Cilag)

This was a company submission for reclassification from prescription medicine to restricted medicine for the symptomatic relief of nausea and vomiting and for the treatment of symptoms of dysmotility-like dyspepsia.

The Committee noted that domperidone was available over the counter in a number of countries including the UK, Ireland and several European countries. OTC domperidone was not indicated for nausea and vomiting in the UK. Domperidone was not marketed in the USA and was a prescription medicine in both Canada and Australia. In spite of a relatively wide OTC use there did not appear to be a great deal of information in the submission relating to this use.

Members agreed that there would be some consumer convenience in having a product available OTC for the treatment of nausea as the only products currently available were prochlorperazine or metoclopramide when in combination with paracetamol. These could be purchased only for nausea associated with migraine.

Antacids and H2 antagonists were available for acid dyspepsia and other gastrointestinal symptoms but were not effective against symptoms caused by dysmotility.

While pharmacists would be able to recommend rehydration and to refer children or the elderly to a doctor if domperidone were to be available as a restricted medicine, it was generally agreed that medication was not the recommended treatment for nausea and vomiting associated with gastro-intestinal infections. Doctors on the Committee agreed that they would rarely prescribe in such circumstances.

The Committee's main concern was that use of the product might mask underlying conditions hence delaying appropriate treatment. However, pharmacists were confident that there would probably be other symptoms which should alert them about when to refer consumers to a doctor. It was noted that consumers suffering from nausea and vomiting would be fairly unlikely to go to a pharmacy. Purchases for this indication would often be made by others on their behalf. The pharmacist would not then have an opportunity to assess whether or not a consumer should be referred to a doctor.

The Committee discussed the findings of a study on non-cardiac QTc-prolonging drugs and the risk of sudden cardiac death published by the European Society of Cardiology . One of the members had investigated references for the study and had noted that sudden cardiac deaths linked to use of domperidone related almost entirely to IV doses, concomitant chemotherapeutic agents and long duration of use. It was agreed that risk of sudden cardiac death was extremely low and was not likely to be an issue with short-term oral doses for intermittent OTC use.

Members noted that the company had supplied copies of the prescription pack but had not included the proposed packaging for OTC use. Nor had the company sought a maximum pack size. The proposed maximum daily dose of 8 tablets was considered too high for OTC use. Members agreed that a maximum of 4 tablets per day as for the UK would be more suitable. The Committee agreed that these matters would need to be addressed before a recommendation could be made about whether or not to reclassify domperidone.

The Committee concluded that the application as it stood was not acceptable for sale of domperidone as a restricted medicine. In order to be acceptable for reconsideration, the Committee was of the opinion that the submission should:

• acknowledge that medication is not best practice for vomiting and not include this as an indication
• limit pack sizes to 20 tablets for limited duration and with a maximum daily dose of 40 milligrams
• contain draft labelling appropriate for OTC sale.

Recommendation

That there be no change to the current prescription medicine classification of domperidone.

6.2 Oseltamivir (Tamiflu 75mg capsules, Roche)

This was a company submission for reclassification from prescription medicine to restricted medicine for the treatment and prophylaxis of influenza in adults and adolescents. A similar submission was currently under review in Australia but no recommendation had yet been made about whether or not to reclassify. The Committee acknowledged the scope of the discussion which had already been undertaken by the NDPSC.

Medsafe had sought advice from the Communicable Diseases and Environmental Health Policy sector of the Ministry of Health about the implications that the OTC sale of oseltamivir might have on the national strategies for managing influenza epidemics or pandemics. The responses received were mixed in that they revealed points both for and against OTC availability in this context. Considerable discussion about various possible scenarios took place. However, members agreed that further investigation and consultation was needed in this area before a recommendation could be made about the classification of oseltamivir and whether or not there was a viable means of incorporating OTC use into a national strategy in the case of an epidemic or pandemic.

None of the Committee had any issues of great concern surrounding the therapeutic index of the product, its toxicity, its potential to be abused or any particular precautions relating to its use with regard to sale as a restricted medicine.

An element of consumer convenience was evident in that immediate access was necessary for the product to be effective and it was not always possible to arrange a doctor's visit within the required timeframe. The ability to be able to purchase the product could reduce the incidence of infection in surgery waiting rooms. There might also be some public good from an employment perspective in the reduction of sick leave due to a reduction in the severity of influenza attacks resulting from timely use of the product.

While there was opportunity for misuse in that some consumers would be likely to self-diagnose influenza when they were suffering from the common cold, this misuse was unlikely to lead to any individual harm. Pharmacist intervention in the sale would identify a reasonable percentage of such misdiagnosis and the high price compared with cold remedies would help ensure purchasers were fairly certain of the diagnosis. Controlling supply so it was available to the public only in areas where influenza had been laboratory-confirmed would help reduce inappropriate use. Members felt that widespread misuse could be seen to lead to possible resistance issues.

The Committee discussed at length the issues surrounding the possible development of resistance. As very little evidence appeared to be available about resistance to neuraminadase inhibitors, members agreed that before proceeding further they would like to see data from the Neuraminadase Inhibitor Susceptibility Network (NISN) which had been set up in 1999 to oversee global surveillance. The NDPSC minutes noted trial results from NISN were likely to come out later in the year. It was possible that these results could influence any decisions which were made. Members also agreed that the company should be approached for any ideas which it might have about monitoring resistance to oseltamivir.

It was agreed that before discussion could be taken further, investigation should be undertaken about the following issues in time for consideration at the next meeting:

• Resistance: NISN data and any other material which might have become available
• Monitoring of resistance: assurance from the company that this would be undertaken and any ideas it might have about how this could be done
• Promotion: how the product would be promoted and whether it could be incorporated as an adjunct into the vaccination scheme
• National strategy: how OTC oseltamivir could be incorporated into a national epidemic or pandemic plan
• Limitation of use: viable means of permitting OTC access only to areas where infection rates have crossed pre-agreed thresholds in a particular area or region. For example, possible mechanisms to permit pharmacists to sell the product without a prescription after a medical officer of health has declared that infection rates have crossed the prearranged threshold.

Recommendation

That a recommendation on the reclassification of oseltamivir from prescription medicine to restricted medicine should be deferred pending further information.

6.3 Simvastatin (10 milligram tablets, GlaxoSmithKline)

This was a company submission for the reclassification of 10 milligram tablets from prescription medicine to restricted medicine. The Committee acknowledged that this was a comprehensive submission which attempted to address the issues which had arisen from the consideration of a similar recent submission by a different sponsor.

Most members were now much happier about the efficacy of the 10 milligram dose. This was based on both better data than that contained in the last submission and on the UK confidence in the potency of the 10 milligram dose. They noted that the UK dose had been based on extrapolation of data for higher doses. While some members still felt that 10 milligrams was a sub-therapeutic dose and was not sufficient for most people with elevated cholesterol levels, it was recognised that this was probably not the section of the population for whom the OTC product was intended.

The Committee was generally happy with the safety of the product for OTC sale. Although side-effects could be serious, these were rare. Pharmacist intervention and good consumer information would probably address potential safety issues in a satisfactory manner.

A number of possible benefits from OTC sale were noted. The Committee thought that compliance would probably be good as consumers might be better motivated to comply if they had to pay for the product. It was thought that a considerable number of people would benefit as the product was likely to be taken by consumers who would not otherwise seek treatment to reduce cholesterol levels. In addition, pharmacy screening would be able to identify those at a higher level of risk and refer them for medical treatment which they might not otherwise receive. Most members were of the opinion that clear indications for use of the OTC product would minimise the risk of under-treatment. It was agreed that access over the counter would potentially lead to a lowering of LDL cholesterol in the population using the medicine.

Possible problems with OTC sale were also discussed. Some members felt that there would inevitably be some consumers who would lead a less healthy lifestyle in the belief that they were protected by the medicine. Another potential problem was seen in that consumers for whom the product was already prescribed might opt to purchase the product and take a double dose instead of continuing to be monitored by their doctor. A third scenario was the consumer who used the medicine unnecessarily though members agreed that little harm would be likely to ensue in such cases. Some of the Committee felt that high cholesterol was only one aspect of cardio-vascular health and that consumer care would be compromised by addressing only one aspect rather than the whole issue.

Issues relating to pharmacist intervention were explored at some length. While some members were concerned about the lack of privacy for conducting cardio-vascular assessments, one of the pharmacist nominees assured the Committee that approximately 70% of pharmacies now had private facilities for assessment. The Committee expressed a strong preference for sale and monitoring to be managed by a single patient-nominated pharmacy and wished further investigation to be undertaken to see whether or not this requirement could be put into practice.

It was agreed that the indication for OTC sale of the product hinged around cardiovascular assessment and that this needed to be done well. As the assessment was based on risk factors the Committee thought that these could be identified by properly trained pharmacists within the group of consumers for whom the medicine was intended. It was also agreed that monitoring the response to therapy would be desirable. Members thought that pharmacists could probably do this but reiterated their desire to see monitoring performed by a single pharmacy.

The need for cholesterol testing was also addressed. Pharmacists could order blood tests, but consumers would have to pay for these. Capillary blood screening, as already performed by some pharmacies, was non-fasting and was less accurate than laboratory testing. However, it was viewed as being sufficiently accurate to identify high LDL cholesterol levels so that pharmacists could refer consumers to a doctor if necessary. This was seen as a useful tool to direct consumers to a doctor for treatment which they might not otherwise receive. While cholesterol testing had not been made compulsory in the UK its practice appeared to be increasing.

Members agreed that they would like to see a baseline cholesterol test undertaken at the start of treatment if simvastatin were to be available over the counter. In addition they would like a test to be undertaken at a later date to assess therapeutic response. They felt that further investigation was needed about whether or not this was feasible for sale with a restricted medicine classification and about whether the company proposed to include this in its training programme.

The product data sheet for simvastatin provided in the submission stated that liver function tests should be carried out before initiating treatment. However, the Committee observed that the company had not addressed the issue of how this should be managed in its protocol for sale as a restricted medicine.

Another matter of some concern to the Committee was the way in which the proposed protocol for OTC use of simvastatin varied from the national recommendations in the Assessment and Management of Cardiovascular Risk guidelines prepared by the New Zealand Guidelines Group. These guidelines recommended that a non-pharmacological approach should be taken to managing cardiovascular risk for those consumers with a risk less than 15%. Pharmaceutical intervention was not recommended by the Guidelines at this level of risk. The Committee felt that this matter needed to be addressed by the company and that some form of endorsement from interested parties would be necessary to justify divergence from the national guidelines. It was noted that, to date, there had been no endorsement from any of those proposed in the company plan for training and no signed-off plan by all parties involved. In addition, there had been no comments from cardiologists, specialist bodies or the Heart Foundation about the proposal to reclassify simvastatin.

Training issues were discussed at some length. One of the members pointed out that the training program used in UK was extremely thorough and outlined the program to the Committee. Members expressed interest in a statin review which had been carried out by the National Institute for Clinical Excellence (NICE) in Britain and was due for publication shortly. They agreed that they would like to see this report before making a recommendation about the reclassification of simvastatin in New Zealand.

The Committee concluded that while the training proposed by the company was good, there were still some issues to be addressed with regard to pharmacist training and the protocols for the sale of the product. Members agreed that their concerns were related to training issues and intervention rather than to the safety of the product. They decided that a recommendation on whether or not to reclassify simvastatin should be deferred until the concerns arising from the discussion had been addressed by the company, firm protocols had been drawn up for training of pharmacists and sale of the product, and sign-off had been agreed to by all interested parties.

Recommendation

That a recommendation about the reclassification of simvastatin be deferred until the Committee's concerns about training and protocols for OTC sale had been addressed by the company.

7. New Medicines for classification

The Committee considered the list of new chemical entities currently under review by the Medicines Assessment Advisory Committee and agreed that these were all suitable for classification as prescription medicines.

Recommendation

That the following be classified as prescription medicines:

• Alemtuzumab
• Anecortave acetate
• Entecavir
• Erlotinib hydrochloride
• Muraglitazar
• Nesiritide (rbe)
• Pegaptanib sodium
• Posaconazole
• Solifenacin succinate
  

8. Harmonisation of NZ and Australian schedules

8.1 Harmonisation matters arising or outstanding

8.1.1 Alclometasone and clobetasone

The NDPSC had requested that the MCC reconsider the current prescription medicine status of 0.05% dermal preparations.

These had now been available in Australia as restricted medicines for some years. During that period there did not appear to have been any problems with their use as over-the-counter medicines. A similar result had become evident from reclassification in the UK. It was noted that these medicines were not widely used and evidence of misuse had not become apparent in either country. Nor did the products appear to be used in place of hydrocortisone as earlier feared by the Committee.

Some members were still concerned with the difficulties of diagnosing skin problems and the ability of pharmacists to undertake this diagnosis. It was noted that dermatologists would be involved in pharmacist training.

Although some Committee members were doubtful about the reclassification it was agreed that New Zealand should adopt the harmonised position provided pack warnings were included against use:

• on the face
• for children
• for psoriasis

In order for these warnings to be enforceable the products would need to be sold only in packs approved specifically for sale as restricted medicines. Required warnings would be included in Part I of The New Zealand Regulatory Guidelines for Medicines . The guidelines would also specify a maximum pack size of 30 grams.

It was noted that the policy statement made by the Committee in November 2000 should now be revoked. This statement stated that topical corticosteroids which were more potent than 1% hydrocortisone or which had a wider range of indications than 1% hydrocortisone should be considered unsuitable for OTC sale.

Recommendation

• That skin preparations containing 0.05% of alclometasone or clobetasone should be reclassified as restricted medicines when sold in pack sizes of 30 grams or less and in the manufacturer's original pack which has received the consent of the Minister or the Director General to its sale as a restricted medicine
• That Medsafe should be asked to include the required warning statements against use on the face, for psoriasis or for children in the New Zealand Regulatory Guidelines for Medicines.
• That the Committee policy statement of November 2000 relating to topical steroids for OTC sale should be revoked.

8.1.2 Antihistamines

The Committee agreed that it had already opted at earlier meetings to accept the principles arising from the recent review of antihistamines. The NDPSC had also agreed to follow these recommendations and was close to finalising their implementation. Acceptance by both parties would result in a consistent and harmonised position on the classification of antihistamines.

The matter had been returned to the agenda of the current meeting because it had become apparent that some companies were expecting consultation on the actual wording for the classification of individual antihistamines rather than reclassification of substances in accordance with the agreed principles. For this reason, a final round of consultation had taken place in which the proposed schedule wording for each antihistamine had been made available.

In addition, there were several matters which still needed to be addressed.

Some medicines had been inadvertently omitted from the list of changes. These were mainly non-sedating antihistamines which were intended to remain as pharmacy-only medicines.

The Chairman said that a number of companies had been under the misapprehension that their combination product had been inadvertently proposed for reclassification from pharmacy-only medicine to restricted medicine. However, this was not the case. All sedating antihistamines had been recommended for reclassification to restricted medicine unless they were in combination with a sympathomimetic decongestant. These combination products, along with the night-time dose of a day/night preparation where only the day-time preparation contained a sympathomimetic decongestant would remain pharmacy-only medicines. All other sedating antihistamines alone or in combination with some medicine other than a sympathomimetic decongestant would become restricted medicines. This included combinations intended only for night use and combinations containing analgesics. Sedating antihistamines which were particularly open to abuse or were not contained in products registered in either country should become prescription medicines. However, reclassification could be sought for the latter products if a company wished to introduce a product containing one of these sedating antihistamines. The Committee noted that currently products for travel sickness containing antihistamines had remained at pharmacy-only level and could identify no clear reason why this should be the case.

Use in children under two years of age
The Committee was concerned that some sedating antihistamine products had dose instructions for children under two years of age. This was considered inappropriate for OTC sale and members agreed that the use in children under two should be addressed at the next meeting with a view to possible reclassification to prescription medicine.

Mepyramine
See agenda item 8.4.8 below.

Meclozine
The Secretary pointed out that during the harmonisation process the pack size of the Boots product had been overlooked. Wording of pack sizes for antihistamines for the prevention of travel sickness had been standardised at 10 tablets. This suited most other products on the market. However, the Boots product contained 12 tablets and had set the former pack size limits for these medicines. It was agreed that meclozine products for prevention of travel sickness should continue to be permitted to contain 12 tablets. It was noted that this product was not sold in Australia and would therefore not have been taken into account when the recommendation was changed to a maximum of 10 tablets per pack.

Cyclizine
The sponsor company for the only product registered in New Zealand containing cyclizine had requested that its travel sickness tablets should be allowed to remain available as a pharmacy-only medicine. The Committee did not see why cyclizine should be treated less restrictively than other sedating antihistamines. It noted that cyclizine was no less sedating than others in this class and had been identified in pharmacies as being subject to abuse. Members recommended that cyclizine should be a restricted medicine for oral use regardless of its indication for travel sickness. Because of its abuse potential, cyclizine was not considered suitable for sale at transport terminals or aboard ships or planes.

Recommendation

• That cyclizine for the prevention of travel sickness should be reclassified as a restricted medicine
• That the NDPSC should be notified of the above recommendation
• That the exemption for the sale of meclozine for travel sickness at travel terminals or aboard ships or planes should retain the pack size of 12 tablets and that the NDPSC should be asked to harmonise on this pack size for over-the-counter sale
• That the classification of sedating antihistamines for use in children under the age of two years should be discussed at the next meeting with a view to possible reclassification to prescription medicine.
• That the NDPSC should be asked for clarification of why sedating antihistamines for travel sickness have remained classified as S2 medicines when they contain only a sedating antihistamine.

8.1.3 Benzocaine

The Committee noted that there were two outstanding issues to be resolved in order to harmonise the classification of benzocaine.

The first matter related to the requirement for the inclusion in the Australian Schedule of an S2 entry for oral use in medicines containing 200 milligrams or less of total anaesthetic substances. The MCC had sought clarification on the need for this entry but had not so far received a response. It was agreed that this matter should be pursued.

The second matter concerned an application from Bayer to reclassify its 0.4% mouthwash product from general sale medicine to pharmacy-only medicine in order to harmonise with the S2 classification in Australia. The New Zealand schedule allowed for all external use of benzocaine at 2% or less to be classified as a general sale medicine whereas the Australian schedule used the cut-off point of 2% to apply only to dermal products.

Although this reclassification would go against the principle of harmonisation at the less restrictive level, the Committee felt that anaesthetic mouthwashes were more appropriately classified at the higher level. In addition, the company had requested the higher level of classification. It was agreed that benzocaine mouthwashes should not be available as general sale medicines and that Medsafe should reword the schedule in order to reflect this change without affecting the classification of other benzocaine products.

Recommendation

That benzocaine should be a pharmacy-only medicine when in mouthwash preparations containing 10% or less of benzocaine.

8.1.4 Kava

At the previous meeting the Committee had agreed that kava should be considered with a view to harmonising with Australia. The NDPSC had recently reclassified kava as a prescription medicine except when it conformed to the conditions below and was exempt from scheduling.

Piper methysticum (kava):

1. in preparations for oral use containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome when labelled with a recommended daily dose of 250 milligrams or less of kavalactones:
   1. containing more than 25 milligrams of kavalactones per dose, labelled with the statement:
      WARNING : Not for prolonged use. Not recommended for use by pregnant or lactating women. May harm the liver;
   2. in tablet or capsule form containing 125 milligrams or less of kavalactones per tablet or capsule or:
   3. in the form of a teabag when the amount of dried whole or peeled rhizome does not exceed 3 grams
2. in topical preparations for use on the rectum, vagina or throat containing dried
   whole or peeled rhizome or containing aqueous dispersions or aqueous extracts
   of whole or peeled rhizome; or
3. in dermal preparations.

The Committee agreed that it had earlier recognised that it did not have the right expertise to make recommendations on herbal products as outlined in the herbal framework which had been proposed some years earlier. However, an expert group, the Kava Evaluation Group had been established in Australia in 2003 to review the safety of kava-containing medicines. The Committee would consequently be in a position to evaluate the information contained in its report. It was agreed that there appeared to be toxicity problems related to kava and that the matter should be considered. Medsafe should request this report and the matter should be returned to the agenda for consideration at the next meeting. One of the members also made reference to a recent German publication on kava and promised to forward details.

Members agreed that a toxicologist would be of great benefit on the Committee and requested that Medsafe also explore the option of including non-medical practitioners on the new scheduling committee.

No recommendation was required at this point on the classification of kava. The matter would be considered at the next meeting.

8.1.5 Stramonium

The NDPSC had recommended that New Zealand amend the cut-off point for exemption from scheduling from 1 mg to 1.2 mg per recommended daily dose on the grounds that it was not consistent with the cut-off point for datura species. The Secretary said that this had probably been due to an oversight in the schedule entry. Members agreed that the entry should be corrected.

Recommendation

That the cut-off point in the schedule entries for stramonium between restricted medicine and pharmacy-only medicine should be amended from 1 milligram per recommended daily dose to 1.2 milligrams per recommended daily dose.

8.1.6 Strychnine and nux vomica

The Secretary informed the Committee that this was another inconsistency in a cut-off point in the schedule. In this case strychnos species were exempt from scheduling in medicines containing one milligram or less per litre or per kilogram of strychnine. However, the nux vomica entry did not have this more restrictive cut-off point and the general exemption of 10 milligrams per litre or per kilogram applied. The Committee agreed that the scheduling should be consistent and that nux vomica should be exempt from scheduling in medicines containing one milligram or less of strychnine per litre or per kilogram.

Recommendation

That nux vomica should be classified as a prescription medicine except in medicines containing one milligram or less per litre or per kilogram.

8.2 Recommendations made by the NDPSC to the MCC in October 2004

8.2.1 Salbutamol and terbutaline

This was a request to reconsider the earlier NDPSC recommendation to harmonise on the restricted medicine classification of salbutamol and terbutaline in dry powder and metered dose aerosol formulations. The MCC had earlier declined a recommendation to harmonise on these medicines. The matter was currently due for two-year review.

While the Committee thought that salbutamol and terbutaline appeared to be reasonably suitable for OTC use when considered against the criteria for OTC sale, there were a number of issues relating to monitoring and management of asthma which were of concern.

There was considerable discussion about the current difficulties of ensuring adequate asthma control. Adequate control was already seen as a problem particularly amongst some sectors of the community such as young adult males. Continued use of salbutamol or terbutaline monotherapy led to a worsening of the condition, and, with long term use, to an irreversible loss of lung function. It was thought that OTC availability of salbutamol or terbutaline inhalers could exacerbate the problem. Making inhaled asthma relievers available without a prescription was seen by some members as a reinforcement of the message to rely on these rather than inhaled steroids. The possibility of making inhaled steroids available concurrently with relievers was considered briefly as a means of assisting better control but was not pursued.

During recent work experience in Australia one of the Committee members discussed the issue of supply of salbutamol with several pharmacists. She commented that there was concern amongst pharmacists in Australia about asthmatics whose condition was not properly controlled. Although pharmacists often recognised these cases as having poorly controlled asthma, they felt obliged to sell inhalers on a patient's demand as they felt they would be liable if the patient suffered a severe attack and did not have an inhaler. Some patients appeared resistant to pharmacists' advice on asthma management.

It was generally agreed that, given the right framework, a system similar to that in New South Wales would probably provide most of the elements needed for asthma control. In addition the Committee agreed it would like to see management by one pharmacy and in conjunction with prescription of a steroid by a GP if necessary. This was not able to be enforced under current conditions There had been no suggestion by any of the sponsor companies in New Zealand for a protocol to mange OTC sale or of a training programme for pharmacists. Nor had there been any proposals from the pharmacy sector for a suitable protocol for the sale of salbutamol or terbutaline inhalers over the counter.

In the absence of a clear management framework for asthma at the pharmacy level, it was agreed there should be no change to the current classification of salbutamol or terbutaline. The Committee indicated if it were to consider a formal proposal to reclassify salbutamol and terbutaline the application would need to contain a treatment protocol that met the requirements of practitioners, asthma educators and stakeholder groups, pharmacists and consumers.

Recommendation

• That there be no change to the current prescription medicine classification of inhaled salbutamol or terbutaline
• That the NDPSC should be notified of the MCC's recommendation not to harmonise on the classification of inhaled salbutamol and terbutaline.

8.2.2 Melia azedarach

The NDPSC had announced its intention to list this plant in Appendix C of the SUSDP. Appendix C lists substances of such danger to health as to warrant prohibition of sale, supply and use.

In order to harmonise at the highest possible level of classification in New Zealand Melia azedarach would need to be classified as a prescription medicine and not be subject to the general exemption for low concentrations. In view of the toxicity of this substance and in the light of the information provided by the NDPSC, the Committee agreed to schedule Melia azedarach as a prescription medicine.

Recommendation

That Melia azedarach should be classified as a prescription medicine at all strengths.

8.2.3 Fosamprenavir

The NDPSC had recommended that fosamprenavir be added to the schedule as a prescription medicine. The Committee noted that fosamprenavir was a new chemical entity not yet registered in New Zealand and used with other antiretrovirals for combination therapy of HIV infection. Members agreed that it should be added to the schedule as a prescription medicine.

Recommendation

That fosamprenavir be added to the schedule as a prescription medicine.

8.3 Recommendations made by the Trans-Tasman Harmonisation Working Party to the MCC in October 2004

8.3.1 Aciclovir

The Working Party recommended that New Zealand should increase the pack size of 5% dermal aciclovir products for general sale from 3 grams to 10 grams to harmonise with Australia. The recommendation was based on a history of safe use in Australia. Members were satisfied that there had been no evidence of misuse of 10 gram packs in Australia and agreed to harmonise on the larger pack size.

Recommendation

That aciclovir should be classified as a general sale medicine for external use for the treatment of herpes labialis in medicines containing 5% or less and in packs containing 10 grams or less.

8.3.2 Hyoscine butylbromide

The NDPSC had recommended that the MCC should reclassify hyoscine butylbromide from: restricted medicine in medicines containing 10 milligrams or less and in packs containing not more than 20 tablets or capsules,
to:
pharmacy-only medicine in medicines containing 20 milligrams or less and in packs containing not more than 200 milligrams of hyoscine butylbromide.

The recommendation was based on an established safety record in Australia.

As on several previous occasions when the classification of hyoscine butylbromide tablets had been discussed, the Committee was not happy to see this product made available without advice at the point of sale. While the safety of the medicine per se was not so much a factor, the Committee's concern lay with the very broad indication for abdominal pain. Members were unanimous in their view that they would prefer that there should be an opportunity to refer consumers to a medical practitioner if they were suffering from abdominal pain.

It was noted that sales were relatively low in New Zealand. Hyoscine butylbromide was prescribed for conditions such as renal colic which was considered inappropriate for self-medication. Dicyclomine for similar indications was classified as a prescription medicine.

The Committee recommended that the classification of hyoscine butylbromide should remain unchanged. As the sponsor company in New Zealand had not shown any interest in changing the New Zealand pack size, members saw no need to recommend that the pack size limits for restricted medicine should be amended.

Recommendation

• That there should be no change to the restricted medicine classification of hyoscine butylbromide.
• That the NDPSC should be informed of the MCC decision not to harmonise on the classification of hyoscine butylbromide.

8.3.3 Savin oil

The NDPSC had recommended that, on the grounds of harmonisation and with regard to the toxicity of the Juniperus sabina plant, the prescription medicine entry for savin oil should be replaced by an entry for Juniperus sabina.

The Committee had previously resisted this change on the grounds that access could be denied to complementary products already on the New Zealand market. However, in view of the toxic nature of all parts of the plant and the fact that there had been no support to retain the current status, the Committee agreed to harmonise on this matter. As Juniperus sabina was listed in Appendix C of the SUSDP it would be necessary to ensure that the general exemption for low concentrations did not apply to this entry.

Recommendation

That the prescription medicine entry for savin oil be replaced by an entry for Juniperus sabina at all strengths.

8.3.4 Alclometasone and clobetasone

For discussion and recommendation see item 8.1.1 above.

8.4 Harmonisation discrepancies which may be resolved without further consultation.

These were harmonisation discrepancies identified in the Trans-Tasman Harmonisation Working Party agenda material for the February 2005 meeting. Consultation was not considered necessary where there were no registered products which contained the medicines in question or if consultation had already occurred.

8.4.1 Naphazoline

Naphazoline for nasal use had been exempt from scheduling in New Zealand when sold at an airport. This exemption did not apply in Australia. As New Zealand had only ophthalmic products registered on the database, it had been recommended that the exemption for nasal use be removed from the schedule in order to harmonise on the classification of naphazoline. The Committee agreed to remove the exemption for nasal use at an airport from the schedule.

Recommendation

That the pharmacy-only schedule entry for naphazoline should be amended to remove the exemption for nasal use when sold at an airport.

8.4.2 Amphotericin

Whereas all amphotericin products were scheduled as prescription medicines in Australia, amphotericin lozenges were scheduled as restricted medicines in New Zealand. Only one amphotericin restricted medicine product was listed on the New Zealand database. The Secretary informed the Committee that she had contacted the sponsor company who was in favour of reclassifying this product to prescription medicine. The Committee agreed that the restricted medicine entry for amphotericin should be removed from the schedule.

Recommendation

That the restricted medicine entry for amphotericin should be removed from the schedule.

8.4.3 Over-the-counter medicines not contained in products in either country to become prescription medicines

A number of medicines had been recommended for inclusion as prescription medicines in both countries as no products were registered in either country. The Committee agreed to recommend that a number of these should become prescription medicines.

Recommendation

That the following should be classified as prescription medicines:

• Butoconazole
• Chlorcyclizine
• Clemastine
• Clemizole
• Dichlorophen
• Dimethothiazine
• Diphenpyraline
• Hexoprenaline
• Hydrargarphen
• Mebhydrolin
• Mequitazine
• Pentylerithritol tetranitrate
• Phenazopyridine
• Phenoltoloxamine
• Thenyldiamine
• Carbuterol

8.4.4 Butraconazole

Medsafe had not found any reference to a medicine of this name. It was thought that the entry may have been included into the schedule as the result of a mis-spelling of butoconazole at some earlier stage and had continued to be retained as a separate schedule entry. The Committee recommended that the entry should be removed from both schedules.

Recommendation

• That butraconazole be removed from the New Zealand schedule
• That the NDPSC be asked to consider removing butraconazole from the SUSDP.

8.4.5 Copaiba balsam

This substance had been a pharmacy-only medicine in the New Zealand schedule but had not been a scheduled medicine in Australia. No reference had been found to the substance in Martindale and the Committee agreed that it was likely to be obsolete. Members thought it unnecessary to include in the prescription medicine schedule an obsolete substance which had never been more highly scheduled than as a pharmacy-only medicine. They also agreed that it was not in the interests of harmonisation to adopt a classification other than the least restrictive unless there was good reason. Members agreed to recommend that copaiba balsam be removed from both schedules.

Recommendation

• That copaiba balsam be removed from the New Zealand schedule
• That the NDPSC be asked to consider removing copaiba balsam from the SUSDP.

8.4.6 Ethyl chloride

The recommendation was that ethyl chloride should become a prescription medicine for inhalation anaesthesia in order to harmonise with Australia. In New Zealand ethyl chloride was classified as a prescription medicine for anaesthesia and a restricted medicine except for anaesthesia.

Although Martindale 34 stated that there was no place in modern anaesthesia for ethyl chloride, there was concern about abuse by inhalation of non-medicinal products in the same way as for nitrous oxide. This was seen to justify its continued maintenance in the schedules. However, maintaining the anaesthesia indication would defeat this purpose as it would permit legitimate use for any reason other than anaesthesia including abuse by inhalation. Retention of the inhalation qualification alone would afford better control over potential abuse of products even though this would leave any other use of the product unscheduled.

Recommendation

• That ethyl chloride should be a prescription medicine for inhalation and unscheduled for other routes of administration
• That the NDPSC should be recommended to remove reference to anaesthesia from its S4 entry for ethyl chloride.

8.4.7 Hydrocyanic acid

Hydrocyanic acid was scheduled only as S4 in Australia. New Zealand had recently reviewed the classification of hydrocyanic acid to allow access for some complementary products. The Committee therefore did not wish to remove that access. They agreed that the NDPSC should be asked to harmonise with the New Zealand position on hydrocyanic acid.

It was noted that the New Zealand exemption from scheduling for hydrocyanic acid was consistent with that in Appendix G of the SUSDP.

Recommendation

That the NDPSC be asked to harmonise with the New Zealand position on the classification of hydrocyanic acid.

8.4.8 Jalap resin

Jalap resin was another substance which had never been scheduled in Australia and was a pharmacy-only medicine in New Zealand. The Committee could see little justification for making this into a prescription medicine, especially as it was a stimulant laxative. Members agreed that its classification should be considered along with that of other stimulant laxatives which would be discussed later on the agenda.

No recommendation was made at this point.

8.4.9 Mepyramine

The recommendation was for mepyramine to become a prescription medicine in both countries. The Committee noted that mepyramine was scheduled S4 in Australia except for oral use which was scheduled S3. This implied that any dermal products would be prescription medicines in Australia. While there were no products available in Australia, one dermal product was available in New Zealand. This had been available over a long period with no evidence to justify a more restrictive classification. While topical antihistamines were thought to cause sensitisation, this did not seem to be a widespread problem and was similar to local anaesthetics which remained available over the counter. The Committee recommended therefore that the NDPSC should be asked to adopt the less restrictive New Zealand classification of prescription medicine (S4) except for dermal use and pharmacy-only medicine (S2) for dermal use. New Zealand would make a prescription medicine entry for mepyramine for uses other than dermal uses in order to harmonise the schedules.

Recommendation

• That mepyramine should be classified as a prescription medicine except for dermal use and a pharmacy-only medicine for dermal use
• That the NDPSC be asked to harmonise with the New Zealand classification of mepyramine.

8.4.10 Pomegranate

This was a further medicine which had been a pharmacy-only medicine in New Zealand and an unscheduled medicine in Australia. Dried bark of the root and stem had formerly been used as an anthelmintic for the expulsion of tapeworms. This use was now considered to be obsolete. The Committee recommended that it follow the agreed principle of harmonisation to adopt the least restrictive classification and delete pomegranate from the schedule. It agreed to recommend that the NDPSC should not include pomegranate as a prescription medicine in the SUSDP.

Recommendation

• That pomegranate should be deleted from the schedule
• That the NDPSC should be recommended not to include pomegranate as a prescription medicine in Schedule 4 of the SUSDP

8.4.11 Stimulant laxatives

The Committee reiterated its earlier opinion that stimulant laxatives should be classified more restrictively than bulk laxatives in order to promote the latter as first line treatment and to afford an element of control over sale of products. Pharmacists had continued to be aware of attempts by anorexics to abuse stimulant laxatives and were able to intervene when necessary. It was agreed that the NDPSC should be recommended to adopt the New Zealand approach to schedule stimulant laxatives as S2/pharmacy-only medicines.

Recommendation

That the NDPSC be recommended to adopt the New Zealand pharmacy-only scheduling for stimulant laxatives.

8.4.12 Aconitum species

The MCC had recently classified these to allow access for complementary products already on the market. Members did not wish to remove this access and recommended that the NDPSC adopt the less restrictive classification of pharmacy-only and general sale for limited pack sizes.

Recommendation

That the NDPSC be recommended to harmonise with the New Zealand classification for aconitum species.

8.4 13 Acriflavin

Acriflavin was a pharmacy-only medicine in New Zealand but had never been scheduled in Australia. As there were no longer any products current on the New Zealand database the Committee recommended that acriflavin be deleted from the schedule.

Recommendation

That acriflavin be deleted from the schedule.

8.4.14 Antazoline

The NDPSC had recommended that the New Zealand schedule should include a prescription medicine entry for antazoline except when used in eye preparations which should be pharmacy-only medicines. As the only products registered in New Zealand containing antazoline were eye preparations the reclassification would not affect the classification of any registered products. The Committee agreed therefore to harmonise with the Australian classification.

Recommendation

• That antazoline be classified as a prescription medicine except for use in the eye
• That antazoline be classified as a pharmacy-only medicine for use in the eye.

8.4.15 Bethanechol

In view of the nature of the indications for this medicine and the fact that there were no longer products on the New Zealand market, the MCC agreed to harmonise with Australia and reclassify bethanechol to prescription medicine.

Recommendation

That bethanechol should be reclassified as a prescription medicine.

8.4.16 Dibrompropamidine/propamidine

It was noted that the Brolene eye preparations recorded on the NZ database contained dibromopropamidine but there were no products listed for propamidine. In Australia there were no products listed for dibromopropamidine which was not scheduled in Australia. However, there was a Brolene eye product on the Australian database which was listed as containing propamidine.

In order to maintain the current classification of the products on the market and in the interests of consistency, the Committee recommended that both countries should have prescription medicine entries for both medicines except when in eye preparations which should be pharmacy-only medicines. In addition, New Zealand should adopt the International Non-Proprietary name for dibrompropamidine.

Recommendation

• That dibrompropamidine and propamidine should be classified as prescription medicines except when for ophthalmic use
• That dibrompropamidine and propamidine should be classified as pharmacy-only medicines for ophthalmic use
• That the NDPSC be recommended to harmonise with the New Zealand position for these two medicines.

8.4.17 Fluticasone

It had been noted that the Australian maximum permitted daily dose for nasal OTC fluticasone was 400 micrograms whereas the maximum dose in New Zealand for the same level of classification was 200 micrograms. Although the other nasal corticosteroids classified at this level also permitted 400 micrograms as the maximum daily dose, the Committee agreed that fluticasone had twice the potency of the other nasal corticosteroids and the dose should be set accordingly. Members recommended that the NDPSC should be asked to adopt the New Zealand maximum daily dose of 200 micrograms of fluticasone for sale as S2/pharmacy-only medicine.

Recommendation

That the NDPSC should be recommended to harmonise with New Zealand on the 200 microgram maximum daily dose permitted for the OTC sale of nasal fluticasone.

8.4.18 Flunisolide

While flunisolide had initially been reclassified to an OTC level of access to be consistent with other nasal corticosteroids, there were no current products on the New Zealand market. The Committee agreed therefore to harmonise with Australia on the classification of flunisolide as a prescription medicine only.

Recommendation

That flunisolide be classified as a prescription medicine.

8.4.19 Icodextrin

In Australia icodextrin was exempt from scheduling under Appendix B of the SUSDP. While it was classified as a pharmacy-only medicine in New Zealand, the Committee agreed that medicines for dialysis were intended to be general sale medicines and icodextrin should be removed from the schedule. However, as there was a product on the New Zealand market, consultation would be required before the change could be made. It was agreed that the classification of icodextrin should be added to the agenda of the next meeting.

Recommendation

That icodextrin be added to the agenda of the next meeting with the intention of reclassification from pharmacy-only medicine to general sale medicine.

8.4.20 Oxiconazole

Oxiconazole was classified as a prescription medicine in Australia. In New Zealand it had been classified to be consistent with other antifungal medicines in this class. No products had been registered to date as restricted medicines. However, there were three products on the database which had been granted consent to market as pharmacy-only medicines. The Committee agreed therefore, that, in the interest of harmonisation at the less-restrictive level, the NDPSC should be recommended to consider adopting the New Zealand classification for products containing oxiconazole. This would mean that the Australian classification of oxiconazole would be consistent with that of most other antifungal agents in the SUSDP.

Recommendation

That the NDPSC should be recommended to adopt the New Zealand classification for oxiconazole.

8.4.21 Quassia

The Committee noted that this was another stimulant laxative which should be treated in the same way as other stimulant laxatives. It was agreed that this had already been covered in the earlier recommendation on laxatives (see item 8.4.10) and that no separate recommendation was necessary.

8.4.22 Quinine

Although the classification of quinine had until recently been harmonised, the NDPSC had reconsidered the classification of quinine as a restricted medicine for the prevention of cramp. This entry had subsequently been removed from the schedule and a recommendation had been made for New Zealand to consider taking similar action. Although there were no products on the New Zealand market which were specifically packaged for sale as restricted medicines, the Committee agreed that consultation should be undertaken before a recommendation was made to remove the restricted medicine schedule entry.

Recommendation

That the classification of quinine as a restricted medicine for the treatment of cramp should be added to the agenda of the next meeting with a view to removing that entry from the schedule.

8.4.23 Sabadilla

The Committee had recently reviewed the classification of sabadilla and had reclassified this medicine in order to permit continued sale of complementary products which were already on the market. For this reason members did not wish to reclassify sabadilla to prescription medicine. It was agreed that the material considered by the MCC should be forwarded to the NDPSC along with a recommendation that they harmonise with the New Zealand classification.

Recommendation

That the NDPSC be recommended to harmonise with New Zealand on the harmonisation of sabadilla and that supporting material should be forwarded to the NDPSC secretariat.

8.4.24 Tranexamic acid

In Australia tranexamic acid was permitted for sale as a restricted medicine when for the treatment of menorrhagia. Tranexamic acid was classified only as a prescription medicine in New Zealand. The Working Party had recommended that New Zealand consider harmonisation with the Australian classification.

Recommendation

That tranexamic acid be added to the agenda of the next meeting for consideration of reclassification to restricted medicine when for the treatment of menorrhagia.

9. For the next meeting

Several medicines had been recommended earlier on the agenda for inclusion on the agenda of the 34^th meeting. These were:

• icodextrin
• quinine
• tranexamic acid
• kava

In addition the Committee discussed a number of other possible candidates for reclassification from prescription medicine to an over-the-counter classification.

Paracetamol 665 milligram tablets

It was brought to the attention of the Committee that harmonisation of paracetamol was not yet achieved due to the classification of 665 milligram tablets. While these were available as pharmacy-only medicines in Australia, they were prescription medicines in New Zealand due to the cut-off point of 500 milligrams per dose unit. This applied to all solid dose forms except powders which were permitted to contain 1000 milligrams per sachet. The Committee agreed that the classification of 665 milligram tablets should be reviewed at the next meeting.

Sumatriptan

The Committee felt that there was need for an alternative over-the-counter treatment for migraine. It was noted that sumitriptan was currently under review in Australia for reclassification. Members agreed that the company should be asked if it would like to make a submission for reclassification.

Omeprazole

The Committee noted that omeprazole and some other similar active ingredients had recently been made available over the counter by a number of regulatory bodies. Members agreed that if the company were able to resolve the difficulties in earlier submissions relating to indications for the product, they would be willing to reconsider omeprazole for OTC sale. They agreed that the company should be asked whether it would like to make a further submission.

Calcipotriol

Calcipotriol for the treatment of psoriasis was noted as another suitable candidate for possible reclassification. It was agreed that the company should be invited to make a submission for reclassification.

Chloramphenicol

Chloramphenicol eye drops were currently under consideration for OTC sale in the UK. Members agreed that they would be happy to consider a similar submission in this country. The sponsor company should be asked if it would like to make a submission for reclassification.

Secretary's note: Chloramphenicol eye drops have since been reclassified in the UK to allow supply by a pharmacist without a prescription.

10. General business 10.1

Electronic submissions and presentation of hard copies

The Secretary informed the Committee that there had been recent applications for information under the Official Information Act with respect to the content of submissions to the Committee. She explained that the reason for requiring companies to submit electronic copies for publication on the Medsafe website was to provide transparency and to eliminate the need for responding to such requests. It had become evident that some companies were providing only summaries of their submissions for electronic publication. Members agreed that full electronic submissions should be supplied. Where information was commercially sensitive the material could be withheld. However, the nature of the material withheld should be declared along with a statement of the relevant section of the Official Information Act to justify its withholding. It was noted that stamping pages 'confidential' did not constitute a valid reason to withhold access to that material. A list of references should be supplied with the electronic submission but reference material need not be included. However, 8 hard copies needed to be supplied of any reference material the applicant wished the Committee to consider. It was agreed that this should be stated as a Committee policy statement and that if companies did not comply, their submissions would not be considered.

The Secretary also said that, in spite of instructions in the guidelines for making submissions to the MCC, some submissions were still being received in ring binders instead of on file pins or spiral binding. Ring binders were unwieldy and the clips often came open during transit. In addition, a considerable amount of time was wasted transferring submissions on to file pins to make them suitable for redistribution or filing. The Committee agreed that a policy statement should also be made about the correct presentation of submissions and that submissions which were not suitably presented should be returned to the sponsor company.

Recommendation

That the following policy statements should be included in the guidelines for making submissions to the MCC:

• Electronic submissions to the MCC should contain the full text of the submission including a list of references. Commercially sensitive material may be withheld but the nature of the material should be declared together with the relevant section of the Official Information Act to justify its withholding. Submissions which do not meet these requirements will not be considered by the Committee.
• Hard copies of submissions should be presented in a secure fashion on file pins, in spiral binding or any other method to minimize their bulk. Small submissions may be presented in folders. Ring binders or arch lever files are not acceptable and may be returned to the sender. 8 hard copies of references should be submitted if the applicant wishes these to be considered by the Committee.

10.2 Consultation on labelling requirements for medicines under the proposed Joint Agency

A set of labelling requirements for medicines under the proposed Joint Agency had been drafted and were open for consultation. It was noted that two of the Committee members had been involved on the labelling committee and that MCC views had already been well represented. However, other members could submit their own comments if they wished by the 17 June 2005 closing date.

10.3 Claims forms

The Secretary reminded members of the appropriate procedures for completing claims forms.

The meeting closed at 4:45pm