Transition to the joint regulatory scheme for prescription and over-the-counter medicines
19 August 2005
Introduction
- Transitional arrangements will be required to give sponsors and manufacturers of prescription and OTC medicines in Australia and New Zealand time to achieve compliance with regulatory requirements under the joint scheme. These arrangements will be based on the principles set out in the Treaty.
- Sponsors of medicines who are legally supplying those products in Australia or New Zealand prior to commencement of the joint scheme will qualify for a transitional approval to be known as an interim product licence. This licence will authorise the continued supply of the medicine, in the jurisdiction in which it was previously being lawfully supplied, for the duration of a defined transition period.
- Manufacturers of medicines who are lawfully manufacturing prior to commencement of the joint scheme will qualify for an interim manufacturing licence, authorising the continued manufacture of those products for the duration of a defined transition period.
- Persons who wish to continue to supply and/or manufacture products beyond the end of the defined transition period must apply to the Agency for a full joint agency product licence or manufacturing licence and must meet all the requirements of the joint scheme.
- Following commencement of the joint scheme, anyone who manufactures or supplies medicines without holding either an interim or a full joint agency licence authorising them do so, will be acting unlawfully and will be exposing themselves to enforcement action by the Agency.
- Interim product licences or manufacturing licences will be issued automatically based on approved product and manufacturing details held by the TGA and Medsafe prior to commencement of the joint agency.
Frequently asked questions
Prescription and Over-the-Counter Medicines
Q1 Are medicines evaluated by TGA and assessed as suitable for supply in Australia prior to commencement of the Agency, considered suitable for supply in New Zealand following startup of the joint agency even if the product has not been evaluated by Medsafe?
Yes. There is no evidence to suggest that the TGA has approved any prescription or OTC medicines that do not meet the standards required by Medsafe. These products will be deemed suitable for a full Agency product licence without further evaluation of data but with an assessment to ensure that they meet Orders (e.g. the labelling order) and joint agency guidelines for details such as product information, consumer medicine information, approved indications and shelf-life. The Agency will have the power to request relevant information from the sponsor.
Q2 Are medicines evaluated by Medsafe, and assessed as suitable for supply in New Zealand prior to commencement of the Agency, considered suitable for supply in Australia following start-up of the joint agency even if the product has not been evaluated by the TGA?
Yes. There is no evidence to suggest that Medsafe has approved any prescription or OTC medicines that do not meet the standards required by the TGA. These products will be deemed suitable for a full Agency product licence without further evaluation of data but with an assessment to ensure they meet Orders (e.g. the labelling order) and joint agency guidelines for details such as product information, consumer medicine information, approved indications and shelf-life. The Agency will have the power to request relevant information from the sponsor.
Q3 How are differences in the terms of approvals for identical medicines in Australia and New Zealand to be resolved?
Although the extent of the problem is not yet known, it is highly likely that many prescription and OTC medicines approved by both the TGA and Medsafe have differing terms of approval. These differences may have resulted from active decisions by the regulator or because different terms of approval were sought in the two countries.
- What if an application has been approved by one agency but rejected by the other?
Certain applications will have been approved by the TGA or Medsafe, however similar applications for approval may have been rejected by the other agency. This may relate to the entire application or may only relate to certain aspects of the application. For example, an application for a new medicine may include application for several, related indications. It is conceivable that one agency may approve use in all indications whereas the other agency may reject certain indications.
In cases where a whole application has been rejected in one country or the other, sponsors will need to provide the Agency with relevant documentation leading to the rejection. A decision on the suitability of the product for a full Agency licence will be made based on these submissions.
In cases where part of an application (eg, certain indication(s)) has been rejected by one country or the other, sponsors will need to provide the Agency with copies of the documents relevant to the decision. A decision on the terms of the full Agency product licence will be made on the basis of these submissions.
The sponsor will need to state clearly what terms are being requested for the full Agency product licence and provide copies of the most recently approved PI/CMI for both countries, a copy of the proposed Agency PI/CMI and copies of the proposed Agency labelling.
the agency will have the power to request relevant information from the sponsor.
- What if sponsors have applied for different terms of approval in Australia and New Zealand for the same product?
In the past, sponsors may have made application to both the TGA and Medsafe for approval of a certain medicine. These applications may have differed in certain areas resulting in different terms of approval. For example additional indications may have been applied for in one or other country, and approved, resulting in different approved indications for the same product in each country.
Where there are differences in the terms of the approvals in Australia and New Zealand, to gain a full Agency product licence, the sponsor will need to declare whether or not any aspects of an application have ever been rejected in either country and if so provide details. Additionally details of the date of approval, including copies of relevant documents will need to be supplied to the Agency. The sponsor will need to state clearly what terms are being requested for the full Agency product licence and provide copies of the most recently approved PI/CMI for both countries, a copy of the proposed Agency PI/CMI and copies of the proposed Agency labelling.
The Agency will have the power to request relevant information from the sponsor.
- What if the product supplied in the two markets is different in terms of formulation and manufacture?
Sponsors will be required to declare whether or not the medicine supplied in the two markets is identical in terms of formulation and manufacture. If different formulations or sites of manufacture are used for supply between Australia and New Zealand, sponsors will need to provide a comparative listing of all formulation and manufacture details with differences highlighted, and state clearly (with justifications) the product(s) which is the subject of the application for a full Agency licence.
Similarly, if chemistry, quality control and biological manufacture details (including shelf-life) are not identical for medicines supplied in the two countries, the sponsor will need to list all chemistry, quality control and biological specifications comparatively, highlighting the differences and clearly state (with justifications) the product(s) which is the subject of the full Agency product licence application.
Additionally, sponsors will need to provide copies of the approved product specifications (eg the certificate of product details or the provisional ARTG record) including shelf life, a copy of the most recently approved PI and CMI, a copy of the proposed Agency PI/CMI and a copy of proposed Agency labels.
The Agency will have the power to request relevant information from the sponsor.
Q4 What is the length of the transition period for the prescription and OTC medicines?
The transition period for all medicines will be three years from commencement of the Agency. All medicines that are the subject of an interim product licence will need to apply for, and be granted, a full Agency product licence within three years of commencement of the Agency.
Q5 What will be the transition process for Australian and New Zealand manufacturers of prescription and OTC medicines?
Manufacturers of medicines that were licensed by either the TGA or Medsafe prior to the commencement of the Agency will be granted a transitional manufacturing licence that will be valid for two years. These Australian and New Zealand based manufacturers will need to apply to the Agency for a full Agency manufacturing licence within nine months of commencement of the Agency. Following the application period, audits of manufacturing sites will be scheduled. These audits will ensure compliance with the Agency code of GMP and will be completed within two years of commencement of the Agency.
Products manufactured by these manufacturers, under an interim manufacturing licence, would be eligible for a full Agency product licence provided that all other Agency requirements were met. Under these circumstances, the full Agency product licence would be subject to the condition that failure to obtain a full manufacturing licence by an agreed date would result in suspension of the product licence.
Q6 What will be the cost of obtaining and maintaining a transitional approval?
All interim (manufacturing and product) licences will attract a fee. These licences will be issued at commencement of the Agency to all current New Zealand and Australian licensed manufacturers, to all sponsors of OTC medicines listed or registered on the ARTG and medicines with Ministerial consent in New Zealand.
The fee incurred for holding an interim licence will be considered as the first annual fee for maintaining an Agency licence.
Manufacture, supply, import or export of therapeutic products in Australia and/or New Zealand will be illegal unless covered by a valid interim (or full Agency) licence and will be liable to prosecution under the new therapeutic products legislation in each country.