PARTICULARS AND SUMMARIES WHICH ARE TO ACCOMPANY A NOTICE GIVEN OR SENT UNDER ARTICLE 4(1)(a)
4.The chemical structural formula for each active constituent or, where...
5.A description of the pharmaceutical form in which the medicinal...
6.The specification of the medicinal product including a statement of...
8.A description of the containers used for the medicinal product...
9.The proposed dosage and its duration, and the methods and...
10.A description of the proposed clinical trial including the duration...
11.(a) A summary of pharmaceutical data in respect of the...
12.(a) Where a specification has been established for a constituent—...
14.Summaries of reports and evaluations of any experimental and biological...
MATTERS IN RESPECT OF WHICH THE LICENSING AUTHORITY SHALL FORTHWITH BE INFORMED OF CHANGES