1. Member States shall take all appropriate measures to ensure that the documents and particulars listed in Article 8(3)(h) and (i), and Article 10(1)(a)(ii) are drawn up by experts with the necessary technical or professional qualifications before they are submitted to the competent authorities. These documents and particulars shall be signed by the experts.
2. The duties of the experts according to their respective qualifications shall be:
(a) to perform tasks falling within their respective disciplines (analysis, pharmacology and similar experimental sciences, clinical trials) and to describe objectively the results obtained (qualitatively and quantitatively);
(b) to describe their observations in accordance with Annex I, and to state, in particular:
- in the case of the analyst, whether the medicinal product is consistent with the declared composition, giving any substantiation of the control methods employed by the manufacturer;
- in the case of the pharmacologist or the specialist with similar experimental competence, the toxicity of the medicinal product and the pharmacological properties observed;
- in the case of the clinician, whether he has been able to ascertain effects on persons treated with the medicinal product which correspond to the particulars given by the applicant in accordance with Articles 8 and 10, whether the patient tolerates the medicinal product well, the posology the clinician advises and any contra-indications and adverse reactions;
(c) where applicable, to state the grounds for using the bibliography mentioned in point (a)(ii) of Article 10(1).
3. Detailed reports by the experts shall form part of the particulars accompanying the application which the applicant submits to the competent authorities.
CHAPTER 2
Specific provisions applicable to homeopathic medicinal products