Paragraph 10 Marketing authorisation applications or proposals where appropriate committee has given advice to the licensing authority before 30th October 2005
This paragraph applies where—
the applicant or holder gives the notice referred to in paragraph 8(4), or 9(2) or (3); or
before 30th October 2005, within—
the period of 28 days after the giving of the licensing authority’s notice referred to in paragraph 9(1), or
such longer period as the licensing authority had allowed,
the applicant or holder gave notice of his wish to make written or oral representations to the Medicines Commission.
The applicant or holder shall, before the end of the period of six months beginning with the date of his notice referred to in sub-paragraph (1), provide the Commission with—
his written representations, or any additional written representations, if he provided written representations before 30th October 2005; or
a summary of the oral representations he intends to make,
and any documents on which he wishes to rely in support of those representations.
If the applicant or holder so requests, the Commission may extend the time limit referred to in sub-paragraph (2), up to a maximum of twelve months from the date of the notice referred to in sub-paragraph (1).
The applicant or holder may not submit any additional representations or documents when the time limit referred to in sub-paragraph (2) and (3) has expired, except with the permission of the Commission.
If the applicant or holder gave notice of his wish to make oral representations, the Commission shall, after receiving a written summary and any other documents in accordance with sub-paragraph (2), arrange for the applicant or holder to make such representations at a hearing before the Commission.