The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998

Amendment of the Homoeopathic Products Regulations

2.—(1) In regulation 1(2) of the Homoeopathic Products Regulations (interpretation)—

(a) after the definition of “the Act” there shall be inserted the following definition—

““administrative variation” means a variation of the provisions of a certificate of registration which does not require, in the opinion of the licensing authority, medical, scientific or pharmaceutical assessment;”; and

(b) after the definition of “homoeopathic medicinal product” there shall be inserted the following definition—

• ““standard variation” means a variation of the provisions of a certificate of registration which, in the opinion of the licensing authority, requires medical, scientific or pharmaceutical assessment and which requires in respect of any homoeopathic medicinal product to which that certificate relates—

  (a)

  the replacement of an excipient used in the manufacture of the product with a comparable excipient;

  (b)

  the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;

  (c)

  a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;

  (d)

  a minor change to the method of manufacture of a homoeopathic stock included in the product;

  (e)

  a change to the specification of any reagent or excipient used in the manufacture of the product;

  (f)

  a change to the finished product specification of the product;

  (g)

  a change to the test procedure for any raw material used in the manufacture of the product;

  (h)

  a change to the test procedure for the product;

  (i)

  a change to the test procedure for the container or other form of packaging immediately in contact with the product;

  (j)

  a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State;

  (k)

  a change to the shape of the container in which the product may be placed on the market;

  (l)

  an additional pack size in which the product may be placed on the market;

  (m)

  a change to the approved storage conditions for the product;

  (n)

  a change to the shelf life of an unopened container of the product or to the shelf life of the product after the container has been opened for the first time; or

  (o)

  a change to the dimensions of an approved dosage form of the product (for example, tablets) which does not entail a change to the quantitative composition or the mean mass of the product;”.

(2) In regulation 11 of the Homoeopathic Products Regulations (variation of certificates)—

(a) after the words “certificate of registration” there shall be inserted the words “for an administrative variation or a standard variation”; and

(b) the words from “which relate to” to the end of the regulation shall be omitted.

(3) For regulation 14 of the Homoeopathic Products Regulations (fees for variations of certificates) there shall be substituted the following regulation—

“Fees for variations of certificates

14.— (1) The fee payable by an applicant in connection with an application for an administrative variation of a certificate of registration pursuant to regulation 11 of these Regulations shall be—

(a) unless sub-paragraph (b) applies, a fee of £75;

(b) where more than one application for an administrative variation is made at the same time by the same applicant and the applications are for identical variations—

(i) in respect of the first application considered by the licensing authority, a fee of £75, and

(ii) in respect of each other application so considered, a fee of £37.50.

(2) The fee payable by an applicant in connection with an application for a standard variation of a certificate of registration pursuant to regulation 11 of these Regulations shall be—

(a) unless sub-paragraph (b) applies, a fee of £150;

(b) where more than one application for a standard variation is made at the same time by the same applicant and the applications are for identical variations—

(i) in respect of the first application considered by the licensing authority, a fee of £150, and

(ii) in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £150,

(iii) in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £75.”.

(4) In regulation 15(1) of the Homoeopathic Products Regulations (fees payable by holders of certificates), for “£15” there shall be substituted “£10”.

(5) In the Table in Schedule 2 to the Homoeopathic Products Regulations (fees for applications for the grant of certificates of registration)—

(a) in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—

(i) for “£100” there shall be substituted “£90”,

(ii) for “£300” there shall be substituted “£270”, and

(iii) for “£500” there shall be substituted “£450”; and

(b) in column (3) (fees for other applications)—

(i) for “£250” there shall be substituted “£225”,

(ii) for “£450” there shall be substituted “£400”, and

(iii) for “£650” there shall be substituted “£585”.