C4C5Part III Further Provisions relating to Dealings with Medicinal Products

Annotations:
Modifications etc. (not altering text)
C4

Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)

C5

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C32

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.

C3C63

Before making an order under this section the F6 Ministers , unless in their opinion it is essential to make the order with immediate effect to avoid serious danger to health F7 ..., shall consult the appropriate committee F1 ....

C34

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).

C35

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

if the organisation have given notice of their desire to be heard, the F8Ministers shall arrange for them to have an opportunity of appearing before, and being heard by, the F3appropriate committee, or

b

if they have made representations in writing, the F8Ministers shall refer those representations to the F3appropriate committee,

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.

C36

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.

C3F47

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.