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The Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971

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Exemption from product licences for certain special manufactured products

2.—(1) The restrictions imposed by section 7 of the Act (restriction as to dealing with medicinal products) shall not apply to the sale or supply of any medicinal product if the conditions specified in paragraph (2) of this Article as to sale, supply and manufacture of that product are satisfied.

(2) The conditions referred to in the preceding paragraph are—

(i)that the medicinal product is sold or supplied,

(a)

to a doctor or dentist for use by him in circumstances to which section 9(1) of the Act relates, or

(b)

to a veterinary surgeon or veterinary practitioner for use by him in circumstances to which section 9(2) of the Act relates, or

(c)

for use in a registered pharmacy, a hospital or a health centre under the supervision of a pharmacist in circumstances to which section 10 of the Act (as modified by the Medicines (Retail Pharmacists—Exemptions from Licensing Requirements) Order 1971(1)) relates, or

(d)

to a person, in the course of whose business herbal remedies are sold, where that medicinal product, being a herbal remedy is to be sold or supplied in circumstances to which section 12(1)(b) of the Act relates, or

(e)

to a person for administration to himself or to a member of his household, where that medicinal product is a product which may lawfully be sold by retail otherwise than in accordance with a practitioner's prescription or from premises other than a registered pharmacy within the meaning of the Act (as modified for the purposes of section 10 of the Act as aforesaid),

or, if sold or supplied through a person lawfully carrying on a retail pharmacy business or a holder of a wholesale dealer's licence (including a person entitled to such a licence by virtue of that person's entitlement to a licence of right), that the medicinal product is sold or supplied for the uses and in the circumstances specified in the foregoing provisions of this sub-paragraph;

(ii)that no advertisement or representation (within the meaning of section 92 of the Act) relating to the medicinal product is issued and that the sale or supply as aforesaid is in response to a bona fide unsolicited order;

(iii)that the manufacture of the medicinal product is carried out under the supervision of such staff and such precautions are taken as are adequate to ensure that that product is of the character and specification required by the person specified in sub-paragraph (i) of this paragraph; and

(iv)that written records as to manufacture in accordance with the preceeding sub-paragraph and as to sale or supply to persons specified in sub-paragraph (i) of this paragraph of the medicinal product are made and maintained, and are available to the licensing authority or the enforcement authority on request of either authority;

(v)that the medicinal product is manufactured by the holder of a manufacturer's licence which relates specifically to the manufacture of medicinal products to which this Article relates.

(3) In respect of the medicinal products to which the preceding paragraphs of this Article relate the provisions of subsection (1) of section 23 of the Act (special provisions as to effect of manufacturer's licences) shall have effect as if the holder of the manufacturer's licence in respect of any such products was also the holder of a product licence in respect of such products or as if such products were manufactured or assembled to the order of a person who is the holder of such a product licence.

(1)

(1971 III, p. 4078).

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