C4C5Part III Further Provisions relating to Dealings with Medicinal Products
Pt. III amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)
Additional provisions
C2 62 C1 Prohibition of sale or supply, or importation, of medicinal products of specified description F5 ....
1
Subject to the following provisions of this section, the F10 ... Ministers, where it appears to them to be necessary to do so in the interests of safety, may by order—
C3a
prohibit the sale or supply, or the importation, of medicinal products of any description, or falling within any class, specified in the order, or (in such manner as may appear to them to be sufficient to identify the products in question) designate particular medicinal products and prohibit the sale or supply, or the importation, of those particular products;
F11b
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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A prohibition imposed by order under this section may be a total prohibition or may be imposed subject to such exceptions as may be specified in the order.
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Where an order is made under this section without prior consultation with the appropriate committee F2 ... in accordance with subsection (3) of this section, the prohibition imposed by the order shall not have effect after the end of such period, not exceeding three months from the date on which it comes into operation, as may be specified in the order, but without prejudice to the making of any further order in accordance with the provisions of this section (including this subsection).
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If any organisation consulted in pursuance of section 129(6) of this Act with respect to a proposal to make an order under this section have given notice to the F8Ministers of their desire to be heard under this subsection, or have made representations in writing to F9the Ministers with respect to that proposal, then before making the order—
a
b
and, where the organisation have availed themselves of the opportunity of being heard, or after considering the representations, as the case may be, the Commission shall report their findings and conclusions to the F8Ministers and F9the Ministers shall take that report into account in determining whether to make the order.
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Subsection (5) of this section shall not have effect where in the opinion of the F12 ... Ministers it is essential to make the order with immediate effect as mentioned in subsection (3) of this section.
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If an order is made under this section and either—
a
the appropriate committee have not considered the proposal to make the order, or
b
the order is made contrary to the advice of the appropriate committee,
the order shall include a statement of the fact that it has been so made.
F138
In this section “the appropriate committee” means whichever the Ministers consider appropriate of—
a
the Commission; or
b
an expert committee appointed by the Ministers, or by one of them acting alone.
Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)