Interpretation2
1
In these Regulations—
“the Act” means the Medicines Act 19683;
“appropriate committee”, for the purposes of any provision of these Regulations under which a function falls to be performed, means—
- a
in a case where—
- i
a committee has been established under section 4 of the Act for purposes which consist of or include any of those specified in subsection (3) of that section, and
- ii
the authority performing that function considers it to be the appropriate committee in the circumstances,
that committee; and
- i
- b
in any other case, the Commission;
- a
“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use4 as amended by—
- a
Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components5,
- b
Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use6,
- c
Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use7, and
- d
Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use8;
- a
“EEA State” means a Member State, Norway, Iceland or Liechtenstein;
“EC traditional herbal registration” means a traditional herbal registration granted by a competent authority of an EEA State in accordance with the simplified registration procedure for traditional herbal medicinal products set out in Chapter 2a of the 2001 Directive;
“licensing authority” shall be construed in accordance with section 6 of the Act;
“parallel import licence” means a traditional herbal registration granted by the licensing authority under these Regulations in respect of a traditional herbal medicinal product which is imported into the United Kingdom from another EEA state in accordance with the rules of Community law relating to parallel imports;
“the relevant Community provisions” means the provisions of the 2001 Directive which apply to traditional herbal medicinal products and to traditional herbal registrations;
“traditional herbal registration” means a registration granted by the licensing authority under these Regulations and includes a parallel import licence.
2
Expressions used in these Regulations which are also used in the 2001 Directive shall have the same meaning as they have there and related expressions shall be construed accordingly.
3
Subject to paragraph (2), section 11 of the Interpretation Act 19789 shall apply for the interpretation of these Regulations as if they were made in the exercise of a power conferred by the Act.
4
Any reference in these Regulations to an application that is signed includes a reference to an application that is signed with an electronic signature.