Paragraph 12 Right to be heard by a person appointed or to make further representations

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

sch 2 am (1.1.2010) by Medicines for Human Use (Marketing Authorisations Etc.) 2009 reg 2
Sch. 2 para. 1 words substituted by Medicines (Products for Human Use) (Amendments to Fees for Variations) 2009 reg. 9(3)
Sch. 2 para. 3 words substituted by Medicines (Marketing Authorisations and Miscellaneous Amendments) 2004 reg. 3(3)
Sch. 2 para. 2(a) substituted by Medicines (Advisory Bodies) 2005 Sch. 2 para. 1(2)
Sch. 2 para. 14(8)(a) word substituted by Medicines (Advisory Bodies) 2005 Sch. 2 para. 1(3)
Sch. 2 substituted by Medicines (Advisory Bodies) 2005 Sch. 2 para. 4
Sch. 2 para. 3 words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(g)(i)
Sch. 2 para. 4(a) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(g)(ii)
Sch. 2 para. 4(b) words substituted by Medicines (Codification Amendments Etc.) 2002 reg. 8(g)(iii)

(1)

Where the applicant or holder gives notice under paragraph 11 of his wish to appear before and be heard by a person appointed for the purpose by the licensing authority, the licensing authority shall make that appointment and—

(a)

the person so appointed shall not, except with the consent of the applicant or holder, be an officer or servant of any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of the Act;

(b)

if the applicant or holder so requests, the hearing shall be in public; and

(c)

if the applicant or holder so requests, the licensing authority shall furnish to him a copy of the report of the person so appointed.

(2)

The licensing authority shall take into account the report of the person appointed and decide whether to renew the authorization, revoke, vary or suspend the authorization or confirm or alter its decision, as the case may be.