Published: 19 October 2016
Provisional consent, under section 23 of the Medicines Act 1981, may be granted when it is desirable that the medicine be sold, supplied, or used on a restricted basis for the treatment of a limited number of patients. Provisional consent is only granted for a period not exceeding two years and will then expire, unless the sponsor applies for a renewal.
Provisional consent is ideally suited to medicines still undergoing clinical assessment but where it is desirable that patients have early access. It is anticipated that the medicine will be used on a restricted basis until the risks and benefits have been quantified and full consent has been granted.
It is the sponsor’s responsibility to maintain provisional consent for a medicine. Applications for renewal of provisional consent must be submitted at least three months prior to the expiry of provisional consent. This is necessary to allow sufficient time for administrative processing, evaluation and publication of the Gazette notice. If an application is received less than three months before the expiry of provisional consent, there may be insufficient time to process a renewal of provisional consent and it will be required to be treated as a new provisional consent. Renewal of provisional consent is for a period of up to two years from the date of expiry.
Sponsors of medicines with provisional consent should address any data deficiencies identified during the initial application to convert to full consent under section 20 of the Medicines Act 1981 within five years of provisional consent initially being granted. If a medicine has conditions relating to restrictions on supplying or prescribing the medicine, it may not be suitable for full consent. Where conditions apply, sponsors should correspond with Medsafe before submitting an application to convert to full consent.
Provisional consent must be maintained during the period that an application for full consent is undergoing evaluation. The evaluation timeframes will not be adjusted to avoid renewal of provisional consent being required. It is recommended that sponsors allow a minimum of 12 months for a conversion to full consent to be evaluated.
The provisional consent expiry date of a product is available on the Product Details, searchable on the Medsafe website using the Product/Application search tool.