Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995U.K.
12.—(1) The Medical Devices (Consultation Requirements) (Fees) Regulations 1995 M1 are amended as follows.
(2) In regulation 1 (citation, commencement and interpretation), in paragraph (2)—
(a)for the definitions of “Annex II” and “Annex III” substitute the following definitions—
““Annex I”, “Annex II” and “Annex III” mean respectively Annex I, Annex II and Annex III to the Directive;”;
(b)in the definition of “competent body”, for the words from “Directive 2001/83/EC” to the end substitute “ the 2001 Directive ”;
(c)after the definition of “the Directive” insert 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, as amended by—
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 components,
Commission Directive 2003/63/EC amending Directive 2001/83/EC,
Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC,
Directive 2004/27/EC of the European Parliament and of the Council also amending Directive 2001/83/EC, and
Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004;”;
(d)omit the definition of “fee”;
(e)in the definition of “manufacturing authorisation”, for the words from “Directive 2001/83/EC” to the end substitute “ the 2001 Directive ”; and
(f)in the definition of “medicinal substance”, for the words from “Directive 2001/83/EC” to the end substitute “ the 2001 Directive ”.
(3) In regulation 2 (circumstances in which a fee is payable), in paragraph (1), after “pay a fee” insert “ specified by, or determined under, regulation 3 ”.
(4) In regulation 3 (fees)—
(a)in paragraph (1)—
(i)in sub-paragraph (a), for “£3,948” substitute “£4,141”, and
(ii)in sub-paragraph (b), for “£9,202” substitute “£9,653”;
(b)in paragraph (2)—
(i)in sub-paragraph (a), for “£781” substitute “ £819 ”, and
(ii)in sub-paragraph (b), for “£2,184” substitute “£2,291”;
(c)in paragraph (3)—
(i)in sub-paragraph (a), for “£3,948” substitute “£4,141”, and
(ii)in sub-paragraph (b), for “£9,262” substitute “£9,653”;
(d)in paragraph (4)—
(i)in sub-paragraph (a), for “£781” substitute “ £819 ”, and
(ii)in sub-paragraph (b), for “£2,184” substitute “£2,291”; and
(e)in paragraph (5)—
(i)in sub-paragraph (a), for “£40,374” substitute “£42,352”, and
(ii)in sub-paragraph (b), for “£10,024” substitute “£10,515”.
(5) After regulation 3 insert the following regulation—
“Fees for pre-consultation meetings
3A.—(1) Where the Department of Health holds a meeting—
(a)with a person other than a notified body for the purpose of providing scientific advice to that person with a view to him making an application for an EC examination certificate in relation to a medical device incorporating a medicinal substance, or
(b)with a notified body for the purpose of providing scientific advice to that body with a view to that body consulting the Department in relation to an application for an EC examination certificate in relation to a medical device incorporating a medicinal substance,
that person or notified body shall pay the fee specified in paragraph (2).
(2) The fee payable shall be—
(a)if the advice provided at that meeting consists of advice in connection with—
(i)quality development only, or
(i)safety development only,
£750;
(b)if the advice provided at that meeting consists of advice in connection with—
(i)quality and safety development only, or
(i)clinical development only,
£950;
(c)if the advice provided at that meeting consists of advice in connection with—
(i)quality and clinical development only, or
(i)safety and clinical development only,
£1,300;
(a)if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development, £1,650.
(3) In this regulation—
“clinical development” means the conduct of studies of a medicinal substance in human subjects in order to—
discover or verify the effects of such a substance,
identify any adverse reaction to such a substance, or
study absorption, distribution, metabolism and excretion of such a substance,
with the object of ascertaining the safety or efficacy of that substance, as required to verify the safety and usefulness of the substance in accordance with paragraph 7.4 of Annex I;
“quality development” means the chemical, pharmaceutical and biological testing required in order to verify the quality of a medicinal substance in accordance with paragraph 7.4 of Annex I;
“safety development” means the toxicological and pharmacological testing required in order to verify the safety of a medicinal substance in accordance with paragraph 7.4 of Annex I; and
“scientific advice” means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a medical device.”.
(6) For regulation 4 (payment and recovery of fees) substitute the following regulation—
“Payment and recovery of fees
4.—(1) Any fee payable in accordance with regulations 2 and 3 shall be paid to the Secretary of State not later than the day on which a notified body consults the competent body.
(2) Any fee payable in accordance with regulation 3A shall become payable within 14 days following written notice from the Department of Health requiring payment of that fee.
(3) All unpaid sums due on account of any fee payable under these Regulations shall be recoverable as debts due to the Crown.”.