23A Interpretation

In this section, and in sections 23B and 23C, unless the context otherwise requires,—

applicant means—

(a)

a person who makes or has made, as the case may be, an application; and

(b)

a person on whose behalf an application is, or has been, made, as the case may be

application means an application for the consent of the Minister under section 20, or for the provisional consent of the Minister under section 23, in relation to a medicine

commencement date means the date this section and sections 23B and 23C come into force

confidential information includes—

(a)

trade secrets; and

(b)

information with a commercial value that would, or would be likely to, be diminished by disclosure of the information

confidential supporting information means confidential information given—

(a)

in, or in relation to, an innovative medicine application; and

(b)

about the medicine that is or was, as the case may be, the subject of that application

ingredient includes a chemical or biological entity

innovative medicine application means,—

(a)

in relation to an application made after the commencement date, an application that refers to an active ingredient—

(i)

that is an active ingredient of the medicine to which the application relates; and

(ii)

that has not, before that application is received by the Minister, been referred to in any other application (except in an application by the applicant for provisional consent for that medicine) as an active ingredient of a medicine; and

(b)

in relation to an application made before the commencement date, an application that referred to an active ingredient—

(i)

that is or was, as the case may be, an active ingredient of the medicine to which the application related; and

(ii)

that had not, before that application was received by the Minister, been referred to in any other application (except in an application by the applicant for provisional consent for that medicine) as an active ingredient of a medicine

protected period means—

(a)

in relation to confidential supporting information, relating to an innovative medicine application, received by the Minister after the commencement date, a period commencing on the date that information is received by the Minister and ending,—

(i)

where—

(A)

the Minister has given notice of consent, not being provisional consent, under section 20, or refused to give consent, in relation to the medicine that is the subject of the innovative medicine application; and

(B)

the date of publication of the notice of consent or the date of the refusal is not more than 5 years after the Minister received an application in relation to that medicine,—

on the date 5 years after the date of that notification or refusal; or

(ii)

in any other case, on the date 5 years after the innovative medicine application to which that information relates is or was, as the case may be, received by the Minister:

(b)

in relation to confidential supporting information, relating to an innovative medicine application, received by the Minister not more than 5 years before the commencement date, a period commencing on the commencement date and ending,—

(i)

where—

(A)

the Minister has given or gives notice of consent, not being provisional consent, under section 20, or refused or refuses to give consent, in relation to the medicine that was the subject of the innovative medicine application; and

(B)

the date of publication of the notice of consent or the date of the refusal is or was, as the case may be, not more than 5 years after the Minister received an application in relation to that medicine,—

on the date 5 years after the date of that notification or refusal; or

(ii)

in any other case, on the date 5 years after the innovative medicine application to which that information related was received by the Minister

WTO country means a country that is a party to the Agreement establishing the World Trade Organization adopted at Marrakesh on 15 April 1994.

Section 23A: inserted, on 1 January 1995, by section 2 of the Medicines Amendment Act 1994 (1994 No 128).

Section 23A confidential information: replaced, on 8 November 2016, by section 11 of the Agricultural Compounds and Veterinary Medicines Amendment Act 2016 (2016 No 82).

Section 23A(a)(i)(A) protected period: replaced, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).

Section 23A(a)(i)(B) protected period: amended, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).

Section 23A(b)(i)(A) protected period: replaced, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).

Section 23A(b)(i)(B) protected period: amended, on 28 October 2021, by section 3 of the Secondary Legislation Act 2021 (2021 No 7).