Notifications for prescription medicines (biological medicines)

• The method being changed must not be a viral safety testing method.
• The in-house test method being changed must be replaced with a pharmacopoeial method. If there are differences in specifications between the two methods, the more stringent specifications should apply.
• The stringency of the specifications should not decrease as a result of the change.
• Batch analytical data for at least three commercial batches should have been generated to demonstrate compliance with the new test and limit.

You must submit:

• Details of the new method.
• An updated CPD document, if applicable.

• The proposed limits must be consistent with the relevant TGA standards and guidelines.
• Do not change the composition of the substance tested. For example, you cannot narrow the test limits for isoelectric point, as this could alter the substance by resulting in the omission of a charged isoform of a protein.
• The change must not be a consequence of any commitment from previous assessments to review specification limits (e.g. made during the procedure for the marketing authorisation application or a variation application).
• The change does not result from unexpected events arising during manufacture e.g. new unqualified impurity; change in total impurity limits.
• The change must be within the range of currently approved limits.
• The test procedure remains the same, or changes in the test procedure are minor.

You must submit:

• The revised set of specifications for the substance.
• An updated CPD document, if applicable.

• The change should not involve changing from the requirements of one pharmacopoeia to those of another.
• Any tests that were performed in addition to those of the pharmacopoeial monograph or TGO must continue to be performed.
• The new pharmacopoeial monograph or amended TGO must be applicable to the substance.

You must submit:

• The revised set of specifications for the drug substance.
• An updated CPD document, if applicable.

• There is no change in test method other than minor changes to existing test methods for physicochemical parameters of the drug product such as pH, density, specific gravity, optical rotation, extractable volume, osmolality, osmolarity or viscosity.
• The test limit must either remain unchanged or be more stringent.

You must submit:

• A summary description of the change and details of the new method.
• An updated CPD document.

You must generate the following data:

• Appropriate validation data demonstrating the new test is at least equivalent to former procedure.

• The new limits must be either the same as, or more stringent than, any applicable standard or guidelines.

You must submit:

• The revised set of specifications.

• The additional test must have been previously evaluated by the TGA.
• The proposed limit (release and expiry) must be based on batch analytical data and comply with, or is more stringent than, any applicable official standard or relevant accepted guidelines for such a test.
• The test method must only be used at a registered quality control testing site that has appropriate GMP clearance.

You must submit:

• Details of the new test method.
• The revised set of drug product specifications at release and expiry.
• An updated CPD document.

You must generate the following data:

• Appropriate validation data for the proposed method.

• The new pharmacopoeial monograph or TGO are suitable for the product.
• The change must not involve changing from the requirements of one pharmacopoeia to those of another.
• Any tests that were performed in addition to those of the pharmacopoeial monograph or TGO must continue to be performed.
• The test method must only be used at a registered quality control testing site that has appropriate GMP clearance.
• If the change involves updating microbiological test requirements for non-sterile products to meet the current Therapeutic Goods Order (TGO) for Microbiological standards for medicines, the product must have undergone a risk assessment for objectionable microorganisms, in addition to those specified in the pharmacopoeias that form the basis of the TGO.
• The change must not be a consequence of any commitment from previous assessments to review specification limits (e.g. made during the procedure for the marketing authorisation application or a variation application) unless the supporting documentation has been already assessed and approved within another procedure.
• The change must not result from unexpected events arising during manufacture, e.g. new unqualified impurity; change in total impurity limits.
• The change must be within the range of currently approved limits.
• The test procedure must remain the same, or the changes in the test procedure are minor.

You must submit:

• The revised set of drug product specifications at release and expiry.
• An updated CPD document.
• For updating microbiological test requirements for non-sterile products to meet the current TGO for Microbiological standards for medicines, an assurance that the report of the risk assessment for objectionable microorganisms is available for review, if required by the TGA.

You must generate the following data:

• Appropriate validation data must have been generated where applicable.

• The change must meet any previously approved test method validity criteria.

You must submit:

• A description of the new equipment.
• An updated CPD document.

You must generate the following data:

• Appropriate validation data must have been generated for the changed equipment using the previously approved criteria and, where applicable, the same validation protocol as was used for the previously approved equipment.
• If the type or brand of consumables used with the equipment is critical (that is, included in the protocol), appropriate validation data must also be generated for the relevant consumables.

• The change may apply to the name or contact details of albumin suppliers or manufacturers, but not to the site or process of manufacture.
  • Changes to site or process of manufacture of albumin products require TGA evaluation of supporting data.

You must submit:

• Details of the new manufacturer or supplier.
• Evidence of GMP clearance, showing the changed name.
• An assurance that the albumin still complies with relevant TGO and other standards such as Ph Eur or BP.

• The new site must either have:
  • for Australian manufacturers, a current manufacturing licence issued by the TGA for this type of manufacture or
  • for overseas manufacturers, current GMP clearance issued by the TGA and valid at the time of this application for this type of manufacture.

You must submit:

• Details of the new manufacturing site.
• The Australian licence and/or GMP clearance number.

• The TGA should have explicitly approved the protocol and acceptance criteria including traceability for establishing a replacement standard. The protocol should have been submitted with the application for registration or a subsequent Category 3 application to change the in-house reference standard. This also includes a change in shelf life of the reference standard.

You must submit:

• Details of the new reference standard, including assigned values.
• The reference to the TGA approval of the protocol (that is, TGA submission number).
• The proposed date of implementation, allowing time for TGA approval.
• An updated CPD document.

You must submit:

• A scientific justification for the column life reduction.

You must submit:

• A scientific justification for the holding time reduction.

• The change must not be due to unexpected events arising during manufacture or because of stability concerns.

You must submit:

• Details of the new shelf life.
• A reason for the planned reduction in shelf life.

• The change must not be due to unexpected events arising during manufacture or because of stability concerns.

You must submit:

• Details of the new shelf life.
• A reason for the reduction in shelf life.

• The change is one of the following:
  • a removal of an excursion temperature
  • a reduction in the time spent out of refrigeration, including time out of the freezer.
• The change must not be due to unexpected events arising during manufacture or because of stability concerns.
• All other changes to the excursion temperature require the TGA to evaluate the data. See our publication Variations to prescription medicines – excluding variations requiring evaluation of clinical or bioequivalence data for more information. 

You must submit:

• Details of the change.

• The change should be to a more restrictive shelf life or storage conditions.
• The change must not be due to unexpected events arising during manufacture or because of stability concerns.

You must submit:

• Details of the change.
• The reason for the change.

• Do not change the internal process controls.
• Do not use the filter for steps that require viral safety validation.
• The new filter meets the same acceptance criteria as the previous filter.
• The new internal process controls for the filtrate have not been changed.

You must submit:

• The reason for the change.
• The new manufacturer’s details.

• Do not change the quality characteristics of the product.

You must submit:

• The reason for the change.
• Details of the new internal process controls.

• Reducing the fermentation period must not change the batch size.
• Do not change the internal process controls.

You must submit:

• The reason for the change.
• Details of the change.

You must submit:

• Details of the change.
• A justification for the proposed reduction.

• Do not change the quality characteristics of the product.

You must submit:

• Details of the change.
• The reason for the change.

• The packaging materials must not be in direct contact with the dosage form.
• The change must not concern a part of the packaging material, which affects the delivery, use, safety or stability of the finished product.

You must submit:

• Details of the change.

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.

You must submit:

• Copies of the existing labels (with tracked changes) and final copies or mock-ups of the amended labels (for each strength, where applicable) which include any logos, design work or graphics. The copies must be to scale and verify the size/dimensions of the labels and indicate the colours to be used. Where there are multiple pack sizes available, one representative label can be provided for each strength, as long as the only difference between the labels is the pack size.

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.
• The addition or change of a pictogram of a product or its dosage form must only be designed to clarify information about the medicine which is useful for the patient, to the exclusion of any element of a promotional nature.
• The change must not involve removal of information relating to the safe use of the product.

You must submit:

• Copies of the existing labels (with tracked changes) and final copies or mock-ups of the amended labels (for each strength, where applicable) which include any logos, design work or graphics. The copies must be to scale and verify the size/dimensions of the labels and indicate the colours to be used. Where there are multiple pack sizes available, one representative label can be provided for each strength, as long as the only difference between the labels is the pack size.

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.
• The new name or address must be the same as amended on the register.

You must submit:

• Copies of the existing labels (with tracked changes) and final copies or mock-ups of the amended labels (for each strength, where applicable) which include any logos, design work or graphics. The copies must be to scale and verify the size/dimensions of the labels and indicate the colours to be used. Where there are multiple pack sizes available, one representative label can be provided for each strength, as long as the only difference between the labels is the pack size.

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.
• The change must not involve removal of information relating to the safe use of the product.

You must submit:

• Copies of the existing labels (with tracked changes) and final copies or mock-ups of the amended labels (for each strength, where applicable) which include any logos, design work or graphics. The copies must be to scale and verify the size/dimensions of the labels and indicate the colours to be used. Where there are multiple pack sizes available, one representative label can be provided for each strength, as long as the only difference between the labels is the pack size.

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.

You must submit:

• Copies of the existing labels (with tracked changes) and final copies or mock-ups of the amended labels (for each strength, where applicable) which include any logos, design work or graphics. The copies must be to scale and verify the size/dimensions of the labels and indicate the colours to be used. Where there are multiple pack sizes available, one representative label can be provided for each strength, as long as the only difference between the labels is the pack size.

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.

• You must submit:

• Copies of the existing labels (with tracked changes) and final copies or mock-ups of the amended labels (for each strength, where applicable) which include any logos, design work or graphics. The copies must be to scale and verify the size/dimensions of the labels and indicate the colours to be used. Where there are multiple pack sizes available, one representative label can be provided for each strength, as long as the only difference between the labels is the pack size.

• There must be no other changes to the label made under this change request.
• The changes must ensure continued compliance with the relevant TGO pertaining to labels and not contravene labelling best practice.
• The new text must not be confusing, promotional or contradictory to text on the container or primary pack labels.

• You must submit:

• Copies of the existing labels (with tracked changes) and final copies or mock-ups of the amended labels (for each strength, where applicable) which include any logos, design work or graphics. The copies must be to scale and verify the size/dimensions of the labels and indicate the colours to be used. Where there are multiple pack sizes available, one representative label can be provided for each strength, as long as the only difference between the labels is the pack size.