Cap. 458 Art. 19Applicability of certain provisions.

(1) The provisions of Titles I, II and III shall apply:

(a) to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process;

(b) in cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a medicinal product and within the definition of a product covered by other Community legislation.

(2) Titles I, II and III of this Act shall not apply to -

(a) any medicinal product prepared in accordance with a magistral formula;

(b) any medicinal product prepared in accordance with an officinal formula;

(c) medicinal products intended for research and development trials, but without prejudice to the provisions of the Clinical Trials Regulations;

(d) radionuclides in the form of sealed sources;

(e) whole blood, plasma or blood cells of human origin, except for plasma prepared by a method involving an industrial process;

(f) intermediate products intended for further processing by an authorised manufacturer.

(3) (a) The Authority may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Act medicinal products supplied in response to a unsolicited order, formulated bona fide in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility.

(b) The Authority may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm: Provided that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product otherwise than for the authorised indications or from the use of an unauthorised medicinal product, when such use is recommended or required by the Authority in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. This shall apply irrespective of whether or not national or Community authorisation has been granted: Provided further that liability for defective products, as provided for by Council Directive 85/374/EEC of 25 July, 1985 on the approximation of the laws, regulations and administrative provisions of the Member States, concerning liability for defective products shall not be affected by the preceding proviso.