S.L. 458.44 ст. 5Particulars to accompany the application.

(1) The application shall be accompanied by:

(a) the particulars and documents:

(i) referred to in regulation 5(1)(c)(i) to (ix), (xi) and (xii) of the Medicines Regulations;

(ii) the results of the pre-clinical (toxicological and pharmacological) tests referred to in regulation 5(1)(c)(x) of the Medicines Regulations;

(iii) the summary of product characteristics, without the data specified in regulation 8(1)(d) of the Medicines Regulations;

(iv) in case of combinations of herbal medicinal products, or as in regulation 3(2), the information referred to in regulation 3(1)(e) relating to the combination as such; if the individual active ingredients are not sufficiently known, the data shall also relate to the individual active ingredients;

(b) any authorisation or registration obtained by the applicant in another Member State, or in a third country, to place the medicinal product on the market, and details of any decision to refuse to grant an authorisation or registration, whether in the Community or a third country, and the reasons for any such decision;

(c) bibliographical or expert evidence to the effect that the herbal medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least thirty years preceding the date of the application, including at least fifteen years within the Community. At the request of the Authority, the Committee shall draw up an opinion on the adequacy of the evidence of the long-standing use of the product, or of the corresponding product. The Authority shall submit relevant documentation supporting the referral;

(d) a bibliographic review of safety data together with an expert report, and where required by the Authority upon additional request, data necessary for assessing the safety of the medicinal product;

(e) Annex I of the Directive shall apply by analogy to the particulars and documents specified in paragraph (a).

(2) The requirement to show medicinal use throughout the period of thirty years, shall be satisfied even where the marketing of the product has not been based on a specific authorisation or if the number or quantity of ingredients of the medicinal product has been reduced during that period.

(3) Where the product has been used in the Community for less than fifteen years, but is otherwise eligible for simplified registration, the Authority shall refer the product to the Committee with all the relevant documentation supporting the referral.