PART 2Administration
Functions of the Commission10
1
The Commission must give advice to either or both of the Ministers in relation to the matters listed in paragraph (2) if—
a
the Minister, or Ministers, request it; or
b
the Commission considers it appropriate to give it.
2
The matters mentioned in paragraph (1) are matters—
a
relating to the execution of any duty imposed by these Regulations or the Clinical Trials Regulations;
b
relating to the exercise of any power conferred by these Regulations or the Clinical Trials Regulations; or
c
otherwise relating to medicinal products.
3
Without prejudice to paragraphs (1) and (2), or to any other functions conferred on the Commission by or under these Regulations, the Commission must—
a
give advice with respect to the safety, quality and efficacy of medicinal products; and
b
promote the collection and investigation of information relating to adverse reactions, for the purposes of enabling such advice to be given.
4
The Commission must also advise the licensing authority if—
a
the licensing authority is required under Schedule 11 (advice and representations) or the Clinical Trials Regulations to consult the Commission about any matter arising under those provisions; or
b
the licensing authority consults the Commission about any matter arising under those provisions.