S.L. 458.44 ст. 9Application of Articles.

(1) The following provisions shall apply, by analogy, to traditional use registration granted under these regulations:

(a) articles 2(a), 2(b), 28(1), (2) and (6), 102, 104A(1) and

110(4) of the Medicines Act;

(b) regulations 4(1)(a) and (b), 9, 12, 15(1) and (2), 18(1),

(2) and (3), 19, 20, 26, 27, 28, 29 and 30 of the Medicines (Marketing Authorisation) Regulations;

(c) the Good Manufacturing Practice in respect of Medicinal Products, Active Substances and Investigational Medicinal Products for Human Use Regulations;

(d) the Manufacture and Importation of Medicinal Products for Human Use Regulations; and

(e) the Pharmacovigilance Regulations.

(2) In addition to the requirements laid down by regulations 2 to 10 of the Medicinal Products (Labelling and Packaging)

Regulations, 2005 any labelling and user package leaflet shall contain a statement to the effect that:

(a) the product is a traditional herbal medicinal product for use in specified indication or indications exclusively based upon long-standing use; and

(b) the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.

(3) In addition to the requirements laid down by the Medicinal Products (Advertising) Regulations, any advertisement for a medicinal product registered under these regulations shall contain the following statement: "Traditional herbal medicinal product for use in specified indication or indications exclusively based upon long-standing use".