Pest Management Regulatory Agency
15 April 2013
ISSN: 1498-5926 (PDF version)
Catalogue number: H113-3/2013-2E-PDF (PDF version)
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The purpose of this document is to communicate to industry and other interested parties revisions to the Pest Management Regulatory Agency's (PMRA) Notification/Non-notification Policy that streamline and expand the changes to registration that can be made through these processes. This directive supersedes Regulatory Directive DIR2001-04, Notification/Non-notification.
Since 1994, the PMRA has provided a mechanism whereby certain minor changes to registered products do not require an application for an amended registration, but may be made through simplified processes known as notification (the PMRA must be notified) or non-notification (the PMRA does not need to be notified).
The Notification/Non-notification Policy was first revised in 2001, expanding the changes that could be made through these processes. This latest revision includes further changes that can be made through notification/non-notification, streamlines the notification process, clarifies previous provisions, and eliminates those that became redundant with the changes to the Pest Control Products Actand Regulations.
In revising the Notification/Non-notification Policy, the PMRA examined similar programs in other jurisdictions, including the United States, United Kingdom and Australia, as well as other Health Canada regulatory programs, and consulted with industry.
The PMRA is confident that the changes in this directive will improve efficiencies for registrants and the Agency, while maintaining the Agency's mandate to protect human health and the environment.
The Agency is also committed to ongoing review and analysis of its submission policies. As further product changes deemed appropriate for notification or non-notification are identified, the PMRA will strive to keep the policy evergreen.
Changes that are reflected in this directive include:
The PMRA will not process any notification requests if there are data protection implications. The regulations for the protection of test data were published in Canada Gazette Part II on 23 June 2010, and can be found at http://gazette.gc.ca/rp-pr/p2/2010/2010-06-23/html/sor-dors119-eng.html.
Based on the outcome of a re-evaluation, special review or new policy implementation, there may be situations where new labelling, specification-related or other requirements that would be appropriate for notification or non-notification are identified, but not covered within the provisions of this directive. In those cases, the regulatory documents outlining the new requirements will indicate how the registration changes are to be implemented (for example, whether the changes are notifiable or non-notifiable or whether an application for amended registration is required).
There also may be circumstances resulting from a special review, re-evaluation or identification of required label corrections, where due to the number of products affected and the urgent nature of the situation, the PMRA may proactively update the PMRA's label of record and notify registrants of this action. It is the responsibility of registrants to ensure that these label revisions are incorporated into the marketplace labels within the specified timeframes or, where no timeframes are provided, at the earliest opportunity.
For changes to registration not identified in Sections 2 through 6 (Notification) or Section 7 (Non-notification) of this directive, or indicated in other PMRA regulatory documents as being notifiable or non-notifiable changes, registrants must continue to submit an "Application for Amended Registration." All such amendments require review and approval by the PMRA before sale of the product.
Any changes to product registrations through notification or non-notification may be audited during the review of subsequent applications.
Notifiable changes are those that may be made to registered pest control products upon submission to the PMRA of a completed notification form.
The documentation requirements for eligible notification submissions are outlined below by category of change. Details on the specific changes that can be made by notification within each category, and any other documentation requirements, are described in Sections 3-6. In all cases the notification form must be completed. Registrants/applicants must also sign the declaration on the form attesting that no changes have been made to the product other than those described on the form, and those identified on the submitted label/Statement of Product Specifications Form (SPSF), that the information provided is complete and accurate, and that the criteria/conditions listed in the directive have been met. For guidance on submitting documents to the Agency, please consult the Pesticides and Pest Management portion of Health Canada's website at http://www.hc-sc.gc.ca/cps-spc/pest/registrant-titulaire/eprs-serp/index-eng.php#il.
Completed notification form.
Label text in MS-Word format with the notifiable changes identified using the track changes feature. Identified changes should include additions to label text as well as deletions that have been stricken. All label components should be submitted, including Emergency Registration supplemental label text (be sure to use the current approved label text). Registrants must attest that the only changes being made to the label are those which are identified. The PMRA will only verify the identified label text and, if acceptable, the full label will be posted to the Pesticides and Pest Management portion of Health Canada's website and become the current label text of record.
Completed notification form.
Supporting documentation, if required (for example, letter of confirmation for change in source of supply of active ingredient).
Indicate the specific change and corresponding values/units.
Completed SPSF. Changes (for example, additions and substitutions/replacements) must be highlighted on the SPSF. Deletions to the SPSF must be indicated on the notification form. Where a product has more than one SPSF, (for example, more than one formulation), include only the SPSFs that have changes. Indicate the formulations that are not changing on the notification form by listing the formulation and version numbers of the SPSFs that have not been submitted. Registrants must attest that the only changes being made to the SPSF are those which are highlighted on the submitted SPSF and/or indicated on the notification form. The PMRA will only verify these changes. If acceptable, these SPSFs will become the SPSFs of record.
Completed notification form.
Letter of confirmation and letter of authorization from the registrant of the source product.
The PMRA will use the information provided (for example, product name, registrant name and address), along with the label of the source product, to generate a label for the new repack and will issue a registration number.
Note: Labels and SPSFs are not to be submitted with the notification request.
Completed notification form.
Supporting documentation as required.
Registrants may proceed with proposed changes once they have notified the PMRA of the change. However, the Agency will process notification requests and advise registrants, normally within 45 days from receipt of the notification submission, if the notifiable change has been accepted or not and if any subsequent action is required. If a notification request is not properly documented or is unacceptable, it will be denied.
In the case of repackaged-relabelled product (repack-relabel) requests, the PMRA must first issue a registration number before the product may be sold.
Registrants must attest on the notification form that the only changes being made to the label text or the SPSF are the ones that have been identified/highlighted. Registrants are advised that it is a contravention of the Pest Control Products Act to make changes to a pest control product that are not in conformance with the provisions of this directive. Where contravention does occur, appropriate corrective action will be required to bring about compliance.
Registrants are encouraged to contact the Pest Management Information Service by telephone or e-mail, as indicated on the front page of this directive, for advice about proposed changes if they are unsure of whether planned changes may be accommodated through notification or non-notification.
The following label changes may be made by notification.
Registrants are responsible for maintaining up-to-date contact information. The PMRA must be informed of any changes to the registrant's address, or the name or address of the Canadian agent. This may be done through notification. When these changes affect multiple products, the affected products may be listed on the same notification form.
Changes to the shape or colour of packaging and related labelling statements are permitted by notification only if all of the following criteria are met:
Note: Changes to packaging for rodenticides, bait/control/attractant stations or other packaging that houses the pesticide during its use, or products with water soluble packaging, are not permitted through notification and require an application for new or amended registration.
The name of a registered product may be changed by notification provided the registration number and registrant do not change. The new name should be specific to the product and may include a distinctive brand or trademark and the common chemical name of the active ingredient, if established. Product names cannot be the same as those of other registered pest control products. Product names that are false, confusing, misleading or make exaggerated claims will be rejected.
References to the product name on the label (for example, in the directions for use) may also be revised through notification. For product labels that do not include references to other products (for example, tank mix partners), registrants may replace the product name with the term: "this product" by notification.
A use site and/or pest may be deleted from a product label by notification provided there remains at least one use site and at least one pest for each use site on the label. The reason for the deletion must be included as a comment on the submitted label.
Registrants may revise outdated disposal statements through notification by choosing the appropriate statement verbatim from the PMRA published standard disposal statements. The PMRA document from which the disposal statement was taken must be referenced on the notification form.
Registrants may adopt standard disposal statements for commercial and restricted class products used in agriculture and non-crop land as specified in Regulatory Directive DIR99-04, Disposal Statements for Control Product Labels (or most recent version) by notification This includes statements for recyclable, returnable and refillable containers.
For products for which standard statements do not apply, or where a registrant wishes to request a variation in the wording of the standard statements, changes to disposal statements must be submitted with an application for amended registration.
The following statement specified in Regulatory Note REG2001-05, Residue Level Label Statement, as required on all labels of products registered for food use, including seed treatment products, may be added to a product label by notification:
"If this pest control product is to be used on a commodity that may be exported to the United States and you require information on acceptable residue levels in the United States, visit CropLife Canada's website at: www.croplife.ca."
Where the PMRA has published standard first aid statements (for example, Regulatory Directive DIR2007-01, First Aid Labelling Statements, or most recent version), registrants may by notification update the first aid statements as appropriate to a product by choosing verbatim the applicable PMRA published standard statements.
The PMRA document from which the first aid statement was taken should be referenced on the notification form.
For antimicrobial products used in the manufacture of paper, the label statement indicating that the pest control product cannot be used in the manufacture of paper that comes into contact with food may be removed through notification. This notification must be accompanied by a letter of no objection issued by Health Canada that clearly supports the pest control product for use on paper with food contact along with a copy of the product specifications and label text provided to support the request for the letter of no objection.
Resistance management statements as detailed in Regulatory Directive DIR99-06, Voluntary Pesticide Resistance-Management Labelling Based on Target Site/Mode of Action(or most recent version), may be added verbatim to product labels through notification provided the criteria outlined in the directive are met.
Certain statements pertaining to product composition may be added to pest control product labels through notification as follows:
A registrant may add through notification a tank mix to a registered product label where that tank mix already appears on the tank mix partner label.
For example, if the label for product A contains a tank mix with product B, the tank mix may be added to the label for product B through notification. The notification request must clearly indicate the exact text that is being added to the label as well as the location of text placement. The text related to the tank mix must be copied in its entirety and must be identical to that which appears on the tank mix partner label.
Once approved for the master product, a tank mix may be added to the related master copy products through notification provided the master copy label contains the uses to which the tank mix applies.
Marketing text may be added to the principal display panel of a label provided it is consistent with the approved directions for use, the text is not false or misleading, and it does not obscure or adversely affect/impair the visibility or legibility of required label text. For example, claims pertaining to specific uses such as "For the control of bed bugs" or "Controls mosquitoes" may be added to the principal display panel of a product label, provided the claim (use) is already specified under the "directions for use" section of the label. Text that requires substantiation, (for example, not obvious that it is consistent with the approved directions for use) may not be added through notification.
Registrants may through notification advise the PMRA of translation corrections made to the French or English label text when omissions or errors are identified.
Corrections of typographical errors on marketplace labels are non-notifiable changes. Please refer to Section 7.1 of this directive.
When a formulant is recategorized to List 1, disclosure labelling may be added through notification providing that a completed notification form and appropriate supporting documentation are received by the PMRA prior to the deadline specified by the PMRA. The following statement must be added to the label in proximity to, on the same panel as, and in a type and font size comparable to, the guarantee statement:
"This product contains the toxic formulant (insert name of chemical) at (insert proportion by weight) %."
If the list of ozone depleting substances governed by the Montreal Protocol is expanded to include additional substances that are formulants, the addition of a warning on the label for a formulation containing these ozone-depleting formulants may be added through notification providing a completed notification form and appropriate supporting documentation is received by the PMRA prior to the deadline specified by the PMRA. The following statement must appear prominently on the principal display panel:
"WARNING: This product contains (insert name of chemical), which harms public health and the environment by destroying the ozone in the upper atmosphere."
If a new allergen is identified as requiring disclosure labelling, the addition of a warning on the label of pest control products containing this allergen may be added through notification providing a completed notification form and appropriate supporting documentation is received by the date specified by the PMRA. The following statement must be added to the label in proximity to, on the same panel as, and in a type and font size comparable to, the guarantee statement:
"WARNING: contains the allergen (insert name of allergen)."
When applicable to a pest control product, the following advisory statement may be added to the product label through notification:
"Users should test (treat) a small, inconspicuous area first to ensure there are no adverse effects such as staining or discolouration."
Where facilities or products exist to allow for refilling, registrants may through notification add the term "refillable" to an end-use product label to indicate that the container may be refilled with the same product. The label must include a statement that indicates the container may only be refilled with the same product (for example, "The container may only be refilled with this pest control product"). Instructions for refilling the container and any purchases required for doing so (for example, purchasing a refill pouch) must also be included on the label.
Certain changes in net contents/container size may be added through notification as described below, provided such changes do not result in changes to use directions (*except as indicated below), mixing instructions, precautionary statements, package type, class designation or other requirements pertaining to size.
Sizes may be removed or a size range narrowed through notification.
For technical and manufacturing class products only, container sizes may be increased through notification provided any associated changes to the disposal statement would be covered by the published standard disposal statements (for example, a standard disposal statement could be used verbatim).
Smaller container sizes may be added to any class of pest control product through notification provided the smaller size does not negatively affect the legibility of the label text, the package size is not reduced to the point that the net contents of the package are smaller than the amount required by the directions for use, and a minimum container size has not been specified by the PMRA (for example, a minimum size of 20g has been specified for capsaicin dog repellent products).
When a master product registration has been amended to change container sizes, the same changes may be made to the related master copy products through notification.
*When a container size/net contents is changed, the use directions may change to accommodate the different size provided the dilution ratio remains constant (for example, a 5 kg container to be mixed with 1,000 litres of water could be changed to a 1 kg container to be mixed with 200 litres of water).
Certain changes to container size/net contents are non-notifiable. Refer to Section 7.2.
Registrants may remove obsolete label information, such as references to other pest control products that are no longer registered, through notification.
The following changes pertaining to product formulations/specifications are notifiable.
A change in the formulation process may be made by notification when:
An application for amended registration is required when changes in the formulation process involve a chemical reaction or the change is beyond the scope of the parameters listed above.
A change in the nominal concentration of a formulant may be made by notification when:
The composition of a product must add up to 100%. Therefore, a change in nominal concentration of any given formulant must be accompanied by information on the identity and change in nominal concentration of other formulant(s), to ensure that the composition of the product adds up to 100%. The same criteria as listed above would apply to these other formulants.
A change in the certified limits of a formulant may be made by notification when:
A change in the supplier of a formulant may be made by notification when:
In cases where the composition of the proposed formulant is chemically similar to the formulant currently contained in the pest control product formulation, a change in formulant may be accepted through notification provided:
The site of formulation for an end-use product or a manufacturing concentrate may be changed by notification, except for microbial (biological) pest control products which require an application for amended registration. Similar changes for a technical grade active ingredient, or an integrated system product (ISP) require an application for amended registration.
Change to a colourant in the form of an addition, deletion or substitution may be made through notification when:
Note that pigments and dyes, while having the same function, are not considered chemically similar and cannot be substituted for each other.
Change to a fragrance in the form of an addition, deletion or substitution may be made through notification when:
A registrant may add or change a source of the same technical grade active ingredient by notification, provided the alternate source:
A letter of confirmation of source of supply (LOC) for the new source of technical grade active ingredient must be submitted with the notification form.
Where the addition of an alternate source results in a change in formulant proportions, the SPSF must reflect this.
A source of active ingredient may be removed from an end-use product or a manufacturing concentrate through notification provided there remains at least one registered source of active ingredient and no other changes are being made.
A formulation and related label statements (for example, allergen or formulation preservative) may be deleted through notification, provided at least one current formulation remains and no other changes are being made.
An alternate formulant(s) and related label statements may be deleted through notification provided the basic formulant remains and no other changes are being made.
The pH range for a pest control product may be revised through notification (for example, from 7 to a range of pH 6-8) provided there is no change in the composition of the product beyond what is allowable through notification.
A material change in pH (for example, from pH 7 to pH 4) cannot be made through notification and requires an application for amended registration.
A guarantee change from minimal to nominal concentration may be done through notification for an end-use product or manufacturing concentrate provided:
A product that is a repack and a relabel of a registered pest control product (known as the source product) may be registered through notification when:
The PMRA will issue a registration number for the repack-relabel product. Labels are not to be submitted; only an identification of the label text that differs from the source product is to be included on the notification form. The PMRA will issue a text label for the repack-relabel product based on the label of the source product including the acceptable text differences.
The following changes may be made to repack-relabel products through notification:
Label changes to a master copy product to match amendments to the related master product may be done through notification provided the master copy product meets the criteria of a repack-relabel product. An LOA from the master product registrant is required to support the addition of new label text that has been approved for the master product.
A pest control product's registration status may be upgraded to master product status by notification provided:
If the PMRA does not have a current LOC (for example, dated within the last five years) for the active ingredient(s) used in the formulation of the product, an updated LOC must be submitted with the notification request.
The initial product status of products which have initial or combined initial master product status may be removed through notification provided there are no associated private label products registered.
There may be cases where certain simple minor label or specification-related changes not specified in this directive, might be appropriate for notification. In such cases, registrants should contact the PMRA to determine the appropriate mechanism for processing the changes (for example, via notification or by submitting an application for amended registration).
Non-notification changes are those that can be made to a registered product without notifying the PMRA.
The following non-notifiable changes may be made to product labelling, packaging or specifications.
The correction of typographical or print errors on marketplace labels are non-notifiable.
Certain changes in the net contents of products are non-notifiable provided such changes do not impact use directions, mixing instructions, precautionary statements, package type, class designation or other requirements pertaining to size. The net content change must fall within the range currently approved by the PMRA for the product. Where a range does not exist, the proposed change must fall between the smallest and largest size currently approved for the product.
Certain other changes in net contents may be submitted as notifiable changes (refer to Section 3.19).
The revision, addition or deletion of the following may be made without notifying the PMRA:
Changes to label format design that do not modify approved label text and are consistent with the requirements of the Pest Control Products Regulations and information contained in other relevant PMRA guidance documents may be made without notifying the PMRA. These may include changes in label colour, company logo, type size or style, use of space, configuration, or placement of label elements. Improvements to label design, label wording and presentation of information, as outlined in Label Process Series documents LPS2011-03, Designing Marketplace Labels of Domestic Class Pest Control Products and LPS2011-04, Guidance for Designing Peel-Back and Multi-Component Labels of Domestic Class Pest Control Products, are non-notifiable.
Where there is no Notice to User Statement on a product label, or where a previous version is currently included on the label, only the following statement may be added to the secondary display panel, as per section 26(2)(a) of the Pest Control Products Regulations without notification:
"NOTICE TO USER: This pest control product is to be used only in accordance with the directions on the label. It is an offence under the Pest Control Products Act to use this product in a way that is inconsistent with the directions on the label. The user assumes the risk to persons or property that arises from any such use of this product."
For domestic class products only, the Notice to User Statement may be removed from the product label without notifying the PMRA.
Pictograms and drawings may be added to the product label without notification, provided that they accurately represent the instructions on the approved label, are not false or misleading, and are consistent with the provisions in Label Process Series LPS2011-03 Designing Marketplace Labels of Domestic Class Pest Control Products or other applicable guidance.
Redundant labelling statements may be removed without notification provided that:
For technical products covered by PMRA Regulatory Directive DIR98-04, Chemistry Requirements for the Registration of a Technical Grade of Active Ingredient or an Integrated System Product (or most recent version) changes in the source of starting materials that are commodity chemicals may be made without notification if the technical grade active ingredient or integrated system product remains in accordance with the specifications upon which registration was granted. Commodity chemicals are products manufactured globally on a large scale using standardized manufacturing methods, with well-defined impurities, and are characterized and sold by nationally or internationally recognized standard specifications. Examples of commodity chemicals include, but are not limited to, sodium chloride, hydrochloric acid and acetic acid. Non-notification is acceptable, therefore, if:
Otherwise, a submission to amend the registration is required. Changes in the source of starting materials that are not commodity chemicals require an application for amended registration.
A statement and/or the Mobius loop symbol reflecting the recycled content of the product packaging may be added to, deleted from or changed on, a label through non-notification provided the statement and symbol are consistent with the Canadian Standards Association June 2008 guidelines document (PLUS 14021) Environmental claims: A guide for industry and advertisers (or the most recent version).
The following non pesticidal information may be added, deleted or changed without notifying the PMRA:
The following standard statement may be added verbatim to the label of commercial class products (excluding adjuvants) used for crop production or vegetation management without notifying the PMRA. Registrants wishing to add a statement that differs from this standard statement must submit an application for new or amended registration.
"In some cases, tank mixing a pest control product with another pest control product or a fertilizer can result in biological effects that could include, but are not limited to: reduced pest efficacy or increased host crop injury. The user should contact [insert registrant name] at [insert contact information] for information before mixing any pesticide or fertilizer that is not specifically recommended on this label. The user assumes the risk of losses that result from the use of tank mixes that do not appear on this label or that are not specifically recommended by [insert registrant name]."
A crop production use is directly related to the activities associated with growing a plant that is intended to be used by humans for any variety of purposes. This includes plants grown for food, feed, fibre, and ornament, among others. Tank mixes may be used for crop production uses during any stage of production (from pre-planting to post-harvest) but excludes applications during storage.
Vegetation management in the context of this notifiable change refers to the management or control of undesirable vegetation (for example, weeds) and is limited to tank mixes that include only herbicides.
The following statement may be added verbatim to a pest control product label without notifying the PMRA provided the label contains buffer zones, and the specified application methods on the label comply with the criteria for being able to use the calculator. Registrants wishing to add a statement that differs from this standard statement must submit an application for new or amended registration.
"NOTE: Applicators may recalculate a site-specific buffer zone by combining information on current weather conditions and spray configuration for the following applications: all airblast applications, and for field and aerial applications which specify the following droplet size category wording on the product label: 'DO NOT apply with spray droplets smaller than the American Society of Agricultural Engineers (ASAE) [Fine or Medium or Coarse] classification.' To access the Buffer Zone Calculator, please visit the Pest Management Regulatory Agency web site."
|Type of Change||Notification||Non-notification||Application for New or Amended Registration|
|Address for registrant or regulatory mail||(3.1)|
|Name and address of Canadian agent||(3.1)|
|Packaging and related statements||Criteria are met (3.2)|
|Deleting a use||(3.4)|
Using PMRA standard disposal statements (3.5)
|Using non-standard statements and variations of the standard statements|
|Trade label statement||(3.6)|
|First aid statement||
Using PMRA standard first aid statements (3.7)
|Using non-standard statements and variations of the standard statements|
|Removal of treated paper with food contact advisory statement||(3.8)|
|Resistance management statement||
Using PMRA standard statement (3.9)
|Using non-standard statements and variations of the standard statements|
|Odour or fragrance||(3.10)|
|Addition of tank mix||Where currently labelled on tank mix partner and text is identical (3.11)||Other tank mixes or variations in label text|
|Marketing text||Where text is clearly consistent with approved directions for use (3.12)||Text that is not clearly supported by the approved directions for use, for example, duration of control claims|
|Translation corrections||For text omissions or errors (3.13)||Typographical or print errors on marketplace labels (7.1)||General "improvement" of translated text|
|List 1 formulant label disclosure||(3.14)|
|Ozone-depleting formulant label disclosure||(3.15)|
|Allergen label disclosure||(3.16)|
|Effects on treated objects or sites||Using PMRA standard statement (3.17)||Other advisory statements|
|Net contents/container size||Notification Criteria are met (3.19)||Non-notification criteria are met (7.2)||Neither notification or non-notification criteria are met|
|Obsolete label information||(3.20)|
|Correction of typographical or print errors||(7.1)|
|Non mandatory label elements||As specified (7.3)||Other non-mandatory label elements/text|
|Notice to user statement||(7.5)|
|Symbols or graphics (pictograms and drawings)||(7.6)|
|Redundant label statements||(7.7)|
|Place of manufacture||(7.10)|
|Consumer access information||(7.10|
|Price or price-related marketing text||(7.10|
|"New" or "improved" formulation||(7.10|
|Unlabeled tank mix||Using PMRA standard statement||(7.11)||Changes to the standard statement|
|Buffer zone calculator reference||Using PMRA standard statement||(7.12)||Changes to the standard statement|
|Formulation process||Criteria are met (4.1)||Criteria are not met|
|Nominal concentration of a formulant||Criteria are met (4.2)||Criteria are not met|
|Certified limits of a formulant||Criteria are met (4.3)||Criteria are not met|
|Supplier of a formulant||Criteria are met (4.4)||Criteria are not met|
|Identity of a formulant/ formulant substitution||Criteria are met (4.5)||Criteria are not met|
|Formulator name or address||For end-use products and manufacturing concentrates that are not microbial pest control products (4.6)||For all technical grade active ingredients and microbial end-use and manufacturing products|
|Colourants||Criteria are met (4.7)||Criteria are not met|
|Fragrances||Criteria are met (4.8)||Criteria are not met|
|Source of TGAI for an EP or MA||Criteria are met (4.9)||Criteria are not met|
|Removal of a source of active ingredient||(4.10)|
|Deletion of a formulation||(4.11)|
|Deletion of alternate formulant||(4.12)|
|Change in pH range||Criteria are met (4.13)|
|Source of starting material for TGAI||Criteria are met (7.8)||Criteria are not met|
|Guarantee conversion from minimal to nominal||For end use products and manufacturing concentrates where guarantee for technical product used is nominal (4.14)||For technical products|
|Registration of repack-relabels||Criteria are met (5.1)||Criteria are not met|
|Amendments to repack-relabels||Criteria are met (5.2)||Criteria are not met|
Upgrade to Master Product
|Criteria are met (6.1)|
|Removal of Initial Product status||Where there are no related private label products registered (6.2)|
|Other potential notifiable changes||Consult the PMRA (6.3)|