Published: 3 December 2014
Committees
Minutes of the 52nd meeting of the Medicines Classification Committee held in the Medsafe Boardroom, Level 6, Deloitte House, 10 Brandon Street, Wellington on Tuesday 21 October 2014 at 9:30 am
Present:
Dr Stewart Jessamine (Chair)
Dr Kate Baddock
Dr Melissa Copland
Mr Andrew Orange
Professor Les Toop
Ms Andrea Kerridge (Secretary)
In Attendance:
Dr Carole Firth (Team Leader, Medicines Assessment)
Ms Frances Greer (Team Leader, Medicines Assessment)
Ms Sarah Reader (Manager, Product Regulation)
Dr Debbie Scarlett (Advisor Science, Medicines Assessment)
Mr Tony Wang (Advisor Science, Medicines Assessment)
Apologies:
Mrs Andi Shirtcliffe
1 |
WelcomeThe Chair opened the 52nd meeting at 9:30 am and welcomed members and guests. |
2 |
ApologiesApologies were received from Mrs Andi Shirtcliffe. Mrs Shirtcliffe had replaced Dr Enver Yousuf as an officer of the Ministry of Health on the Committee. Although not present, Mrs Shirtcliffe provided comment on agenda items in advance of the meeting which were added to the discussion. |
3 |
Confirmation of the minutes of the 51st meeting held on Tuesday 8 April 2014The Secretary requested that the following statement under agenda item 5.1.1 (sildenafil - proposed reclassification from prescription medicine to restricted medicine) be deleted from the minutes: Training material and packaging would be reviewed by Medsafe as part of the product approval process. The Committee agreed that the statement could be deleted because it was misleading. The final recommendation from the Committee was that sildenafil should be reclassified from prescription medicine to prescription medicine except when sold by a registered pharmacist under specific conditions. Any product containing sildenafil would still be a prescription medicine and so no application would be submitted to Medsafe. Also, reviewing training material is not part of Medsafe's product approval process. The rest of the minutes of the 51st meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair. One member commented that from reading the minutes they were unsure whether this particular item (regarding the reclassification of sildenafil) would come back to the Committee for further discussion. The Chair confirmed that if an agenda item was to be added to the agenda of the next meeting, it would be stated in the minutes (under agenda item 9). The Secretary agreed to keep members informed of agenda items that progressed without coming back to a meeting. The Chair also reminded the Committee that it is their role to make recommendations to the Minister of Health regarding the classification of medicines. It is the Minister of Health that makes any final decision. (Note that Ministerial powers in relation to classification have been delegated to the Chief Medical Officer who acts as the Minister's Delegate.) |
4 |
Declaration of conflicts of interestThe Conflict of Interest forms were returned to the Secretary. The following conflicts of interest were declared:
All other members declared they had no additional interests which would pose a conflict with any of the items on the agenda. |
5 |
Matters arising |
5.1 |
Objections to recommendations made at the 51st meetingNo valid objections had been received. |
5.2 |
Reclassification of rizatriptan from prescription medicine to restricted medicine following a recommendation at the 43rd meetingAt the 43rd meeting on 13 April 2010, the Committee recommended that rizatriptan 5 mg wafers should be reclassified from prescription medicine to restricted medicine for the acute treatment of migraine with or without aura. The current classification of rizatriptan is:
The Committee noted at the last meeting that, since this reclassification, the company had not produced an approved pack for sale as a restricted medicine. The Committee were also presented with a summary of down-scheduled products following a reclassification submission since the 42nd meeting on 3 November 2009. The summary consisted of 18 products, all of which had been approved at the new level of classification following the reclassification submission. So since November 2009 there had not been another situation where since a reclassification a company had not produced an approved pack for sale. One comment was received during the consultation period. It supported keeping the classification of rizatriptan as a restricted medicine because the unavailability of a specific product was not viewed as affecting the classification status or the safety of supply from a pharmacist. The Committee discussed potential options. No change to the prescription medicine and restricted medicine classifications of rizatriptan could be recommended. This would support the Committee's recommendation made at the 43rd meeting. Alternatively, the Committee could recommend that rizatriptan be reclassified to a prescription medicine only which is what had happened in Australia. This recommendation would have no consequence on any products currently marketed. However, it would set a precedent for any future reclassifications when a reclassification is recommended but not followed with an application for a product at the new classification. Following discussion the Committee agreed there was no safety information demonstrating that the initial recommendation to reclassify rizatriptan was inappropriate. The Committee therefore concluded that there should be no change to the prescription medicine and restricted medicine classification of rizatriptan. RecommendationThat there should be no change to the current classification of rizatriptan. |
5.3.3 |
Classification of cetirizine as a pharmacy-only medicineThe current classification of cetirizine is:
Cetirizine is available as a general sale medicine when in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 5 days' supply. The Committee discussed the suggestion from one member that it may be more logical for the prescription medicine entry to read 'except when specified elsewhere in this Schedule'. This suggestion was also relevant to the classification of loratadine and fexofenadine. The prescription classification of both loratadine and fexofenadine is also 'except for oral use'. The Chair explained that the intent of the Committee in recommending the reclassification of non-sedating antihistamines from prescription medicine to pharmacy-only medicine was to place them in a similar classification to the antihistamines already classified as pharmacy-only medicines. The pharmacy-only classification was for oral use in any pack size for any indication. The exemption allows a specific pack size and dose to be available as a general sale medicine for the treatment of seasonal allergic rhinitis. The Committee noted that whilst it would be consistent with the rest of the Schedule to update the prescription medicines entries of cetirizine, fexofenadine and loratadine to 'except when specified elsewhere in this Schedule', there were no safety reasons necessitating such a change. The Committee agreed that there should be no change to the current classification of cetirizine. However, this comment would be taken into account when the Schedule was next updated. RecommendationThat there should be no change to the current classification of cetirizine. |
5.4 |
Suggested guidance on training materials included in a submission for reclassificationOver the past few years, a number of reclassification submissions have resulted in a recommendation from the Committee to reclassify with the condition that some form of training course should be completed. These submissions have resulted in the following reclassifications:
While it is not in the Committee's remit to discuss the training requirements of vaccinators or pharmacists, officials within Medsafe had suggested it would be pertinent for Medsafe, as the medicines regulator, to provide general guidance on what aspects of medicines information should be included in any training materials submitted with a submission for reclassification. This guidance could then be included in the document, Guidance on how to change the legal classification of a medicine in New Zealand, which is published on the Medsafe website (at http://www.medsafe.govt.nz/downloads/How_to_change_medicine_classification.pdf).). The guidance on what to include in any training materials submitted with a submission for reclassification could include:
The Committee considered the suggested guidance as a starting point for discussion. It was noted that, whilst the trend for requiring training for specific medicines was initially a useful step to instil trust and confidence around pharmacy's ability to deliver these medicines safely, there was uncertainty as to whether this approach should continue. Training provided was confidential to the submission for reclassification and there was no onus to update the training material in a recommendation for reclassification. One member questioned whether a reclassification should be recommended by the Committee if so much was required in terms of training to mitigate any risk from reclassification, as this should be an argument for not reclassifying a medicine. Specialist training is available to healthcare professionals to widen their scope of practice. In addition, pharmacists can undertake a postgraduate prescribing course. One member hoped that the training for specific medicines could eventually be incorporated into the undergraduate pharmacy degrees. The Committee or Medsafe cannot enforce any pharmacist training. However, it was agreed that it would be useful to set up a meeting between Medsafe and the bodies responsible for pharmacy training to discuss the way forward. The Committee recommended starting this discussion by Medsafe meeting with the Medical Council of New Zealand and the Pharmacy Council of New Zealand. The New Zealand Medical Association, Pharmaceutical Society of New Zealand and any other organisation suggested by the two Councils should also be invited to subsequent meetings to ensure a sector wide approach. The Committee agreed that the Chair should initially write to the Medical Council of New Zealand and the Pharmacy Council of New Zealand suggesting a meeting to discuss the training materials in a submission for reclassification. The Committee requested that they be allowed to comment on the content of the letter before it was sent. RecommendationThat the Chair should write to the Medical Council of New Zealand and the Pharmacy Council of New Zealand suggesting a meeting to discuss the training materials in a submission for reclassification. The letter should be circulated to members for comment before being sent. |
5.5 |
Matters arising for information |
5.5.1 |
Letter from the Royal New Zealand College on General PractitionersThe Royal New Zealand College of General Practitioners were unable to provide comment on agenda items. An email from the Secretary regarding the published agenda had been blocked for unknown reasons so was not received. However, The Royal New Zealand College of General Practitioners stated they were reassured to know that the two general practitioners on the Committee, while not attending as College representatives, would be able to provide a general practice perspective on the proposals under consideration. |
5.5.2 |
Classification of avanafil, empagliflozin, ledipasvir and riociguat as prescription medicinesAn out-of-session consultation took place in August 2014 regarding the classification of avanafil, empagliflozin, ledipasvir and riociguat. The Committee recommended that avanafil, empagliflozin, ledipasvir and riociguat should be classified as prescription medicines. These classifications were gazetted on 4 September 2014. |
5.6 |
Late agenda item - Classification of fluoride when present in drinking waterTwo recent High Court cases (New Health New Zealand Incorporated v South Taranaki District Council and New Health New Zealand Incorporated v Attorney General) have determined that fluoride and fluoride producing substances are not medicines when used to fluoridate domestic water supplies in New Zealand. In n New Health New Zealand Incorporated v Attorney General, the High Court recommended a Regulation be made to the Medicines Regulations 1984 to exempt fluoride substances from the definition of medicines when used to fluoridate water. It had been suggested that the recommendation may be achieved earlier by way of an update to the classification statements of fluoride in the Schedule (via section 106 of the Medicines Act 1981) whilst the update to the Medicines Regulations 1984 was being drafted. The Committee considered including the statement, 'except when present in public drinking water', to the current prescription medicine, restricted medicine and pharmacy-only medicine classifications of fluoride. These statements would specifically exempt fluoride from the Schedule when present in drinking water. The Committee discussed whether a concentration should also be included in the Schedule. The concentration of fluoride in public drinking water should not exceed 1.5 mg/L so this could specifically be included. Alternatively, the Schedule already states that, unless specific reference is made otherwise, every reference to a medicine in the Schedule applies only if the concentration of the medicine is greater than 10 mg/L or kg. The Committee agreed that advice should be sought from Health Legal in the Ministry of Health regarding any specific reference to a concentration of fluoride when present in drinking water. One member was concerned with updating the Schedule. The Schedule is a list of medicines. If fluoride was not considered a medicine when present in drinking water then it should not be referenced in a Schedule of medicines. RecommendationThat if an update to the Schedule was required whilst the update to the Medicines Regulations 1984 was being drafted, the prescription medicine, restricted medicine and pharmacy-only medicine statements of fluoride should be updated to include the statement, 'except when present in public drinking water'. That, if required, advice should be sought from Health Legal in the Ministry of Health regarding any specific reference to a concentration of fluoride when present in drinking water. Secretary's note - Following the meeting, advice has been provided to Medsafe that this recommendation (ie, updating the Schedule) is no longer required. The Ministry has commenced urgent proceedings to update the Medicines Regulations 1984. |
6 |
Submissions for reclassification |
6.1 |
Beclomethasone - proposed reclassification
from pharmacy-only medicine to general sale medicine
|
6.2 |
Omeprazole - proposed reclassification
from pharmacy-only medicine to general sale medicine
|
6.3 |
Paracetamol in combination with phenylephrine
|
7 |
New medicines for classificationThe following new chemical entities were submitted to the Committee for classification. |
7.1 |
Dasabuvir, ombitasvir and veruprevir - Viekira Pak 137.50mg / 250mg film coated tablet and Viekira Pak-RBV 200 mg RBV, 1000 mg RBV and 1200 mg RBV film coated tabletsVeruprevir and ombitasvir are co-formulated as film-coated immediate release tablets. The tablet also contains copovidone, d-alpha-Tocopheryl acid succinate, propylene glycol monolaurate, sorbitan monolaurate, silicon dioxide, sodium stearylfumarate, polyvinyl alcohol, macrogol 3350, purified talc, titanium dioxide, and iron oxide red. The tablets do not contain gluten. The strength for the fixed dose combination tablet is 75 mg veruprevir/50 mg ritonavir/12.5 mg ombitasvir. Dasabuvir is formulated as a 250 mg film-coated, immediate release tablet containing microcrystalline cellulose, lactose, copovidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene macrogol 3350, purified talc, and iron oxide yellow, iron oxide red and iron oxide black. Viekira Pak / Viekira Pak-RBV is indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with cirrhosis. Duration of therapy and addition of ribavirin are dependent on patient population. Dasabuvir, ombitasivir and veruprevir are not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3). RecommendationThat dasabuvir, ombitasvir and veruprevir should all be classified as prescription medicines. |
7.2 |
Nintedanib - OFEV 100 mg and 150 mg soft gelatin capsulesNintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and β) and fibroblast growth factor receptors (FGFR 1-3) kinase activity. Ninetanib binds competitively to the ATB binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells). In addition Flt-3, Lck and Src kinases are inhibited. Nintedanib is a small molecule tyrosine kinase inhibitor including the receptors platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptors (FGFR) 1-3, and vascular endothelial growth actor receptor (VEGFR) 1-3. Ninetanib binds competitively to the ATB binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation, migration and transformation of fibroblasts representing essential mechanisms of the IPF pathology. In addition nintedanib inhibits Flt-3, Lck and Src kinases. OFEV is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer of adenocarcinoma tumour histology after first line chemotherapy. OFEV is also indicated for the treatment of Idiopathic Pulmonary Fibrosis and to slow disease progression. Nintedanib is not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3). RecommendationThat nintedanib should be classified as a prescription medicine. |
7.3 |
Pomalidomide - Pomalyst 1 mg, 2 mg, 3 mg and 4 mg capsulesPomalidomide has direct anti-myeloma tumouricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma (MM) tumour cell growth. Specifically, pomalidomide inhibits proliferation and induces apoptosis of haematopoietic tumour cells. Additionally, pomalidomide inhibits the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergises with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumour cell apoptosis. Pomalidomide enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. Pomalidomide demonstrated anti-angiogenic activity in a mouse tumour model and the in vitro umbilical cord model. Pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. Pomalidomide is not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3). RecommendationThat pomalidomide should be classified as a prescription medicine. |
7.4 |
Siltuximab - Sylvant 100 mg and 400 mg powder for infusionSiltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6. Siltuximab prevents the binding of human IL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of the hexameric signalling complex with gp130 on the cell surface. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T and B- cells, lymphocytes, monocytes and fibroblasts, as well as malignant cells. IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. Overproduction of IL-6, in chronic inflammatory diseases and malignancies has been linked to anaemia and cachexia and has been hypothesised to play a central role in driving plasma cell proliferation and systemic manifestations in patients with CD. Sylvant is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab is not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3). RecommendationThat siltuximab should be classified as a prescription medicine. |
7.5 |
Turoctocog alfa - NovoEight 250 IU powder for injectionNovoEight (turoctocog alfa; human coagulation factor VIII) is a purified protein for use in the clinical management of factor VIII deficiency (haemophilia A or classic haemophilia). Turoctocog alfa is produced by recombinant DNA technology in Chinese hamster ovary cells and is a third generation FVIII product prepared without the use of serum or other animal-derived components. The manufacturing method of NovoEight minimises the risk of transmission of viral diseases. NovoEight is indicated for the treatment and prophylaxis of bleeding episodes in patients with haemophilia A, including control and prevention of bleeding in surgical settings. Turoctocog alfa is not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3). Blood clotting factors were already available as general sale medicines. Therefore, turoctocog alfa should be made available as a general sale medicine. RecommendationThat turoctocog alfa should be made available as a general sale medicine. |
8 |
Harmonisation of the New Zealand and Australian schedules |
8.1 |
New chemical entities which are not yet classified in New Zealand |
8.1.1 |
Insulin glargineInsulin glargine is an insulin analogue. Insulin glargine is indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia. In July 2014, the Delegate made a final decision to include insulin glargine in Schedule 4 (prescription medicine) with an implementation date of 1 October 2014. Insulin glargine was already classified in New Zealand and Australia as a prescription medicine under the group entry for insulins. Therefore, no classification recommendation was required. The Scheduling Secretariat in Australia had been approached for an explanation as to why insulin glargine was listed separately as well as being classified under the group entry. However, an explanation had not been received. RecommendationThat insulin glargine should not be added to the New Zealand Schedule as a prescription medicine because it is already classified as a prescription medicine under the group entry for insulins. |
8.1.2 |
NalmefeneNalmefene is an opioid antagonist. Nalmefene had been proposed for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high risk drinking level, without physical withdrawal syndrome and who do not require immediate detoxification. The product should be prescribed in conjunction with psychosocial support focused on treatment adherence and reducing alcohol consumption. In July 2014, the Delegate made a final decision to include nalmefene in Schedule 4 (prescription medicine) with an implementation date of 1 October 2014. The Committee noted that nalmefene would not be captured in the Schedules of the Misuse of Drugs Act 1975. RecommendationThat nalmefene should be added to the New Zealand Schedule as a prescription medicine. |
8.1.3 |
Normal human immunoglobulinNormal human immunoglobulin is a human immunoglobulin G. Normal human immunoglobulin is indicated in adults and children for replacement therapy in Primary Immunodeficiency Disease and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. In April 2014, the Delegate made a final decision to include normal human immunoglobulin in Schedule 4 (prescription medicine) with an implementation date of 8 April 2014. Normal human immunoglobulin was already classified in New Zealand and Australia as a prescription medicine under the group entry for immunoglobulins. Therefore, no classification recommendation was required. The Scheduling Secretariat in Australia had been approached for an explanation as to why normal human immunoglobulin was listed separately as well as being classified under the group entry. However, an explanation had not been received. RecommendationThat normal human immunoglobulin should not be added to the New Zealand Schedule as a prescription medicine because it is already classified as a prescription medicine under the group entry for immunoglobulins. |
8.1.4 |
PerampanelPerampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid glutamate receptor on post-synaptic neurons. It had been proposed for adjunctive treatment of partial-onset seizures. In July 2014, the Delegate made a final decision to include perampanel in Schedule 4 (prescription medicine) with an implementation date of 1 October 2014. The Committee noted that perampanel would not be captured in the Schedules of the Misuse of Drugs Act 1975. RecommendationThat perampanel should be added to the New Zealand Schedule as a prescription medicine. |
8.1.5 |
SerelaxinSerelaxin is a recombinant human relaxin-2, a vasoactive peptide hormone. Serelaxin is proposed for use in patients with acute heart failure. In April 2014, the Delegate made a final decision to include serelaxin in Schedule 4 (prescription medicine) with an implementation date of 8 April 2014. RecommendationThat sereaxin should be added to the New Zealand Schedule as a prescription medicine. |
8.2 |
Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary's Delegate)The Committee noted that the Delegate had also made the following amendments to the Standard for the Uniform Scheduling of Medicines and Poisons:
|
8.2.1 |
Decisions by the Delegate - April 2014Decisions also included under agenda item 8.1. A new Schedule 3 (restricted medicine) entry should be created for esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply. The Committee considered harmonising with the above classification. Esomeprazole is currently classified as a prescription medicine in New Zealand. The Committee noted there were no products currently available that could be affected by the proposed reclassification. Although hypothetically safer than omeprazole, there was less experience in using esomeprazole in New Zealand. The Committee agreed it would be preferable to wait until a submission for reclassification was received in New Zealand. Although there was no apparent safety reason not to harmonise, there was not enough information in the Reasons for the Delegate's Decision to make a recommendation. RecommendationThat a restricted medicine entry should not be created for esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply. b) Macrogols A new Schedule 2 (pharmacy-only medicine) entry should be created for macrogols in preparations for oral use as a liquid concentrate for laxative use. The Committee considered harmonising with the above classification. Macrogols, in oral preparations for bowel cleansing prior to diagnostic, medical or surgical procedures, are currently classified as restricted medicines in New Zealand. This classification followed a recommendation by the Committee at its 24th meeting on 2 November 2000. At the 30th meeting on 26 November 2003, the Committee recommended that macrogols should remain unscheduled for laxative use. Macrogols are available as general sale medicines for laxative use. The Committee noted there were currently nine products currently marketed that could be affected by a recommendation to reclassify. From the information in the Reasons for the Delegate's Decision, it was unclear to the Committee why a pharmacy-only medicine entry should be created for macrogols in preparations for oral use as a liquid concentrate for laxative use. It was stated that there were concerns regarding the potential for misuse of the liquid concentrate so supply needed to be in an environment where advice from a healthcare professional would be available. However, no adverse events had been reported in New Zealand regarding laxative use. The Committee agreed that the Scheduling Secretariat in Australia should be asked for further information on why this decision was made before a recommendation could be made. RecommendationThat a new pharmacy-only medicine entry should not be created for macrogols in preparations for oral use as a liquid concentrate for laxative use. That the Scheduling Secretariat in Australia should be asked for further information on why the Delegate decided to include a new Schedule 2 (pharmacy-only medicine) entry should be created for macrogols in preparations for oral use as a liquid concentrate for laxative use. |
8.2.2 |
Decisions by the Delegate - May 2014No harmonisation decisions relevant to the Committee were made by the Delegate. |
8.2.3 |
Decisions by the Delegate - July 2014Decisions also included under agenda item 8.1. A new Schedule 3 (restricted medicine) entry should be created for naproxen when in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age. The Committee considered harmonising with the above classification. Naproxen is currently classified as a:
The Committee noted there were no products currently marketed that would be affected by a recommendation to reclassify. The Committee agreed it would be preferable to wait until a submission for reclassification was received in New Zealand. Although there was no apparent safety reason not to harmonise, there was not enough information in the Reasons for the Delegate's Decision to make a recommendation. RecommendationThat a new restricted medicine entry should not be created for naproxen when in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age. |
8.2.4 |
Decisions by the Delegate - August 2014No harmonisation decisions relevant to the Committee were made by the Delegate. |
9 |
Agenda items for the next meetingThe following items will be added to the agenda of the next meeting:
|
10 |
General business |
10.1 |
Articles for informationThe Committee were presented with the following articles for information:
|
11 |
Date of next meetingTo take place on a Tuesday in April 2015. The Secretary would email members for their availability. |
There being no further business, the Chair thanked members and guests for their attendance and closed the meeting at 2:35 pm.