Microsoft word - nzsmi submission medregs-25mar2010final.doc

Submission Booklet: Consultation on Proposed Amendments
to Regulations under the Medicines Act 1981
Submissions close on 26 March 2010.
You do not have to answer all the questions or provide personal information if you donot want to.
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Are you submitting this as:(Tick one box only in this section) an individual (not on behalf of an organisation) Regulations under the Medicines Act 1981 ConsultationPolicy UnitHealth and Disability Systems Strategy DirectorateMinistry of HealthPO Box 5013Wellington, 6145 Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981
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under the Official Information Act 1982.
All submissions will be acknowledged, and a summary of submissions will be sent tothose who request a copy. The summary will include the names of all those whomade a submission. In the case of individuals who withhold permission to releasepersonal details, the name of the organisation will be given if supplied.
Do you wish to receive a copy of the summary of submissions? Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981
Submission Questions
Question 1
Do you agree that fluoride dentifrices and anti-dandruff preparations should no longerbe regulated as related products under the Medicines Act? If not, why not? teeth). We understand that the intent is to deregulate fluoride mouthwashes as well and wouldprefer to see this clearly stated. The new regulation under 105(1)(i) would need to accountfor liquids such as mouthwashes and non-liquids such as toothpastes and powders, preferablyin alignment with the Australian schedules. With respect to anti-dandruff preparations there needs to be a general statement that activesthat are unscheduled can be used in anti-dandruff preparations, eg Ketoconazole <1% Question 2
Do you think compliance with the Cosmetic Products Group Standard provides
adequate assurance about the safety of these products? If not, what alternative
would you suggest? Please detail your alternative, give reasons for supporting that
alternative and describe the impacts of the alternative you are suggesting.
Question 3
Are there any other types of products you consider should be excluded from
regulation under the Medicines Act? If so, why should they be excluded and how
should they be regulated instead? What would be the impact of excluding these
products?
Many other products should be excluded from regulation under the Medicines Act.
Particularly products that are considered devices overseas but are expected to be registeredas Related Products or even Medicines in New Zealand. Attempts to try and register thesetypes of products are met with significant and often insurmountable regulatory hurdles asthese type of products are not regulated in the same way overseas. This issue is compoundedby cases of such products being marketed without any regulatory approval as the need toregister them is unclear in the guidelines. We suggested the following products are suitable for exclusion from the Medicineslegislation: Tooth whitening systemsHead lice treatmentsAnti-dandruff shampoo with Ketoconazole <1%Eye lubricants (that are used on the eyelid but not in the eye)Anti acne products with salicylic acid < 2% for prevention & control of acne (sold ascosmetic in Australia) Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981
Topical rubs such as linimentsThroat lozenges that contain unscheduled ingredients registered and others are not.
Barrier creams to seal out wetness (eg as used to prevent rather than treat nappy rash). Wenote that currently some of these are registered as lower risk medicines)Medicated soapsProducts at the device / medicine interface such as pregnancy test kitssaline nasal spraysspermicidal condoms. Question 4
Do you support each of the proposed changes to the labelling requirements? If not,
why not? What alternative changes would you prefer to see? Please detail your
alternative, give reasons for supporting that alternative and describe the impacts of
the alternative you are suggesting.
Question 5
Are there other changes you consider should be made to labelling requirements for
medicines and related products? Please detail the changes, your reasons for
supporting those changes and the impacts of the changes you are suggesting.
Ensure the definition of single dose units is comprehensive enough, eg Labelling ofindividually wrapped dose units such as transdermal patches, single dose tablets, lozenges orcapsules and sachets The change needs to make it clear that the sachets, foil, wrapper or pouch is NOT the primarylabel, the outer carton is. TGO 69 does not require the batch and expiry date to be added to the label of an individuallywrapped dosage unit that are in unsealed protective cover, it is only required for individuallywrapped goods if the single dose is sealed into an individual sachet or blister. Adopting thesame requirements in NZ allows for greater harmonisation of labelling. Proposed non-sedating antihistamine warning. RASML does not have an equivalent warning.
Adding this warning to the NZ requirements removes any prospect of future harmonisation.
The requirement for a warning needs to be removed for non-sedating antihistamines and notreplaced with an alternate warning. Accept TGO 69 for Foil labelling of Safety containers, ie one set of text per 2 blister positions Consider changing reg 15 so that the PDP does not have to contain the quantities of theac the names of all actives but the quantities are on the back label Amend 22(3) to make it clear that wo Prolonged or excessive use can be harmful. Do not give to children under 2 years of ageexcept on medical advice.”, eg no dose instructions un Amend Reg 15(4) to remove the limits on the size of the PDP being 1/3 of the label for acylindrical container. This is especially onerous for small containers The number of actives required to be listed on the PDP should be harmonised with Australiawhere products with more than 4 actives can be listed on the back label. Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981
Remove the limits of the size of a sample pack being 1/3 the size of the smallest commercialpack. This is impossible for single dose products and unworkable for many others wheresmall packs are marketed Sample packs currently require the dose to be included on the printed label. This can be verydifficult for products with multiple indications or doses. Allowance for a blank space for theprescriber to add the dose would solve this problem. Consider the issue of website addresses being included on labelling. There seems to be somevariation on how this is evaluated / approved. Clearer guidelines would be helpful Currently there is no provision to include the name of a second, complimentary product onthe labelling of the first product without it being considered advertising. This should beallowed where the 2 products are clearly complimentary to each other and aid consumerawareness and compliance, eg athletes foot creams and powders. Transparent packaging should not be considered labelling. Wrapping a product in a clear,transparent wrap may be done for security or other reasons and provided it does not obscureany registered labelling should be allowed without recourse to Medsafe. This change willalso align with TGO 69 Question 6
Do you support the proposed changes to advertising requirements? If not, why not?
Question 7
Are there other changes you consider should be made to the advertising
requirements? Please detail the changes, give reasons for supporting those changes
and describe the impacts of the changes you are suggesting.
The proposed Ad code submitted to Medsafe by the NZSMI is far more detailed than this –comments have been made on the marked up version as attached Excluded advertisements need to be expanded to include sponsorships, reminders, brandnames, logo or pictures providing they do not include a therapeutic claim –care is needed toprovide details without restricting future changes ie is a branded car or bus excluded if noclaims are made? The requirement that there is a warning statement about any known serious adverse effects,or contra-indications in a known group of people is not clear. Does this mean that thecurrent NSAID and analgesic warnings are no longer required (Stomach ulcers, incorrectus The following is taken from the current regulations, comments are highlighted
8 Advertisements for medicines
 (1) Subject to regulation 11(2) of these regulations, every advertisement for a medicine, other than a label or a price list or branded POS and promotional itemswithout therapeutic claims , shall include the following: (a) A statement of the quantities of the active ingredients in the medicine: Asrequested - Revoke except for mail order direct mail or internet marketing (b) A statement of the authorised uses of the medicine: As requested,Confirm that this deleted as it is deemed to be included in the pack shot? (c) A statement of the appropriate precautions to be taken in the use of themedicine: Except for excluded ads and Internet/direct mail advertising Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981
(d) A statement of any contra-indications to the use of the medicine: Exceptfor excluded ads and Internet/direct mail advertising (e) A statement of the known or likely poisonous effects of, or adversereactions to, the medicine. Except for excluded ads and Internet/direct mailadvertising (2) Every medical advertisement that refers to an ingredient of a medicine by nameshall state the appropriate designation of the ingredient. Confirm applies only toInternet or direct mail order etc??(3) Subject to subclause (4) of this regulation, every advertisement for anyprescription medicine, restricted medicine, or pharmacy-only medicine shall include,conspicuously printed (in the case of a printed advertisement) or clearly spoken (inthe case of an oral advertisement), the following words: Is this being revoked exceptfor RX ? Need to confirm that the mandatories listed above are all that will be required going forward,i Please confirm if a consolidated Medsafe code will be published, on the website, in theNZRGM? Name and address of advertiser is in Act, S59. However it seems an exemption can begr Act 62 (1) d, allows regulations to be made as required. No comment on Professionalrecommendation or testimonial, both are in Act S58 so difficult to change –wh Question 8
Do you support the proposed amendments to regulation 43, coupled with the
development of clear criteria and standard requirements for the issue of waivers, as a
way to enable electronic transmission of prescriptions to proceed in the short term,
until more extensive provisions can be included in primary legislation? If not, why
not? What alternative mechanism would you suggest? Please detail your alternative,
give reasons for supporting that alternative and describe the impacts of the
alternative you are suggesting.
Question 9
Do you agree that the Regulations should be amended so that prescribing rights for
medical practitioners, dentists and midwives are aligned and are governed by the
pr
would you suggest? Please detail the changes, give reasons for supporting thosechanges and describe the impacts of the changes you are suggesting.
Question 10
Do
into line with other prescribers? If not, why not? Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981
Question 11
Do you agree that it would be appropriate to extend the limits on supply of
prescription medicines in the proposed circumstances? If not, why not?
Question 12
Are there other circumstances in which you think the period of supply should be
extended beyond three months (or six months for an oral contraceptive)? Please
specify the circumstances and the impact of the changes you are suggesting.
Question 13
Do you support the requirement for the patient to be in New Zealand when
prescription medicines are prescribed for them (or normally resident in New Zealand
but temporarily overseas)? If not, what alternative measures (if any) do you suggest?
Please detail your alternative, give reasons for supporting that alternative and
describe the impacts of the alternative you are suggesting.
Question 14
Do you agree that substitution should be allowed under the proposed conditions? If
not, why not and what alternative provision for substitution would you suggest?
Please detail your alternative, give reasons for supporting that alternative and
describe the impacts of the alternative you are suggesting.
Question 15
Do you agree with the proposal to allow the issuer of a standing order to determine
the circumstances in which countersigning of administration records is required? If
not, why not? What alternative (if any) would you suggest? Please detail your
alternative, give reasons for supporting that alternative and describe the impacts of
the alternative you are suggesting.
Question 16
Do you agree that unscheduled medicines should be able to be sold by vending
machine? If not, why not?
Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981
Question 17
What do you consider would be the impact on businesses of allowing unscheduled
medicines to be sold by vending machine?
Question 18
Are there any particular limitations you consider should be placed on vending
machine operators? Please specify.
Consideration of storage conditions, stock control, expiry dates and security. The contact
number for the vending machine supplier needs to be prominently displayed so that any and
all issues are directed to them in the first instance
Question 19
Do you support the proposed changes to the Regulations in relation to data sheets to
bring them into line with current practice? If not, why not? What alternative would you
suggest? Please detail your alternative, give reasons for supporting that alternative
and describe the impacts of the alternative you are suggesting.
Question 20
Do you agree that the content and format of data sheets should be specified in
guidelines rather than in Regulations?
Yes, provided any changes proposed are first subject to consultation with industry
Question 21
Do you support the above changes to definitions relating to pharmacy qualifications?
If not, why not?
Question 22
Are there any other definitions in regulation 2 that you think should be updated?
Please provide details, give reasons why you think the changes are necessary and
describe the impact of those changes.
Question 23
Do you agree that regulation 6 should be revoked and a list of acceptable colouring
substances incorporated into regulatory guidelines published on the Medsafe
website? If not, why not? What alternative would you suggest? Please detail your
alternative, give reasons for supporting that alternative and describe the impacts of
the alternative you are suggesting.
Yes provided any changes proposed are first subject to consultation with industry. Please provide a positive and negative list of colouring substances. A negative list showsapplicants that a colour has already been considered and rejected. Please consider removing Tartrazine from the negative list. This colour is currently allowedin food in NZ and is also allowed in Europe Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981
Question 24
Do you support the proposed changes to the information required to be included on a
prescription? If not, why not? What alternative (if any) would you suggest? Please
detail your alternative, give reasons for supporting that alternative and describe the
impacts of the alternative you are suggesting.
Question 25
Do you support the proposed changes to remove outdated requirements relating to
the dispensing of prescriptions? If not, why not? What alternative (if any) would you
suggest? Please detail your alternative, give reasons for supporting that alternative
and describe the impacts of the alternative you are suggesting.
Additional Points for Consideration
container used in the packaging of a medicine and made of glass or plastic shall comply with the tests for that type of container (if any)speci Please confirm if the USP alone is still appropriate here? Should other pharmacopeiabe included? Is it time this was reviewed to ensure that the list of medicines in safety containers isappropriate?The blister pack/platform. Within the definition of safety containers we should include“ Clarify that Licences are not required for GSL medicines and that Company licencesrather than individual licences can be granted Submission booklet: Consultation on Proposed Amendments to Regulations under
the Medicines Act 1981

Source: http://www.nzsmi.org.nz/documents/NZSMI%20Submission%20medregs-25Mar2010FINAL.pdf