Amendment of the Homoeopathic Medicinal Products for Human Use Regulations 19949

The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M1 are amended as follows—

a

in regulation 1(2) (interpretation) after the definition of “certificate of registration” there is inserted the following definition—

“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 use;

b

in regulation 1(3) (interpretation) for “Council Directive 92/73/EEC” there is substituted “ the 2001 Directive ”;

c

in regulation 2 (application)—

i

for “Article 1(4) and (5) of the 1965 Directive” there is substituted “ Article 3 of the 2001 Directive ”, and

ii

for “Article 2(4)” there is substituted “ Article 5 ”; and

d

in regulation 5(1)—

i

for “Article 7 of Council Directive 92/73/EEC” there is substituted “ Article 14 of the 2001 Directive ”, and

ii

for “Article 9” there is substituted “ Article 16 ”.