The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment (No. 2) Regulations 1990
Citation, interpretation and commencement1.
Amendment of principal Regulations2.
For each amount specified in column (3) of the Schedule to these Regulations, where it appears in the provision of the principal Regulations specified in relation to it in column (1) of that Schedule (the subject matter of which is indicated in column (2) of that Schedule), there is substituted the amount specified in relation to it in column (4) of that Schedule.
Revocation of regulation 1(3) of the principal Regulations3.
Regulation 1(3) of the principal Regulations (exemption for National Health Service authorities) is hereby revoked.
Amendment of Part I of Schedule 1 to the principal Regulations4.
““qualified person” means the person named in the licence as being the person who is to carry out the functions specified in paragraph 16(3) of Schedule 2 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 19715 in relation to a manufacturer’s licence or paragraph 8 of Schedule 3 to those Regulations in relation to a wholesale dealer’s licence;”.
Amendment of Part III of Schedule 1 to the principal Regulations5.
(1)
In paragraph 2 of Part III of Schedule 1 to the principal Regulations (variations of manufacturers' licences), for the words “paragraph 4” there shall be substituted the words “paragraphs 4A and 5”.
(2)
In paragraph 3 of Part III of Schedule 1 to the principal Regulations (variations of wholesale dealers' licences), for the words “paragraph 4” there shall be substituted the words “paragraphs 4B and 5”.
(3)
“Other variations to Product Licences4.
The fee payable under regulation 6(a) of these Regulations in connection with an application for variation of a product licence shall be £100 in respect of each variation applied for which falls within one of the following paragraphs—
(a)
a change of either or both of the name and the address of the holder of the licence;
(b)
a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise and any change of address does not involve a change of the site of manufacture, assembly or storage or from which distribution takes place;
(c)
the removal from the licence of details of one or more sites of manufacture, assembly or storage or from which distribution takes place;
(d)
the removal from the licence of details of any of the activities to which the licence relates;
(e)
the removal from the licence of details of any of the indications authorised for administration of the medicinal product;
(f)
in relation to a product licence (parallel import), the removal from the licence of details of any of the medicinal products which the holder of the licence is authorised to import.
Other variations to Manufacturers' Licences4A.
The fee payable under regulation 6(a) of these Regulations in connection with an application for variation of a manufacturer’s licence shall be £100 in respect of each variation applied for which falls within one of the following paragraphs—
(a)
a change of either or both of the name and the address of the holder of the licence where any change of address does not involve a change of the site of manufacture, assembly or storage or from which distribution takes place;
(b)
a change of either or both of the name and the address of an assembler, storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or from which distribution takes place;
(c)
the removal from the licence of details of one or more sites of manufacture, assembly or storage or from which distribution takes place;
(d)
the removal from the licence of details of one or more persons named as a qualified person, as the person to be in charge of quality control or as the production manager;
(e)
the removal from the licence of details of a medicinal product or range of medicinal products which the holder of the licence is authorised to manufacture;
(f)
the removal from the licence of details of one or more manufacturing or assembly operations specified in the licence as an operation which the holder of the licence is authorised to carry out.
Other variations to Wholesale Dealers' Licences4B.
The fee payable under regulation 6(a) of these Regulations in connection with an application for variation of a wholesale dealer’s licence shall be £100 in respect of each variation applied for which falls within one of the following paragraphs—
(a)
a change of either or both of the name and the address of the holder of the licence where any change of address does not involve a change of the site of wholesale dealing or storage or from which distribution takes place;
(b)
a change of either or both of the name and the address of a storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise and any change of address does not involve a change of the site of wholesale dealing or storage or from which distribution takes place;
(c)
the removal from the licence of details of one or more sites of wholesale dealing or storage or from which distribution takes place;
(d)
the removal from the licence of details of one or more persons named as a qualified person;
(e)
the removal from the licence of details of any medicinal product or range of medicinal products which the holder of the licence is authorised to sell or offer for sale by way of wholesale dealing.”.
Amendment of Schedule 2 to the principal Regulations6.
In Schedule 2 to the principal Regulations (fees for inspections)—
(a)
in paragraph 1(1)—
(i)
in the definition of “major inspection”, after the words “60 or more” there shall be inserted the words “, but fewer than 250,”;
(ii)
““supersite inspection” means an inspection at a site at which 250 or more relevant persons are employed.”;
(b)
in paragraph 2—
(i)
“(iv)
in respect of a supersite inspection, £10,200.”;
(ii)
“(iv)
in respect of a supersite inspection, £17,000.”;
(iii)
“(iv)
in respect of a supersite inspection, £6,800.”.
Amendment of Schedule 3 to the principal Regulations7.
In paragraph 3 of Schedule 3 to the principal Regulations (waiver, reduction or refund of fees)—
(a)
after the words “wholesale dealer’s licence” there shall be inserted the words “or for a variation or for a renewal of a manufacturer’s or a wholesale dealer’s licence”; and
(b)
for the words “regulation 3(a)” there shall be substituted the words “regulations 3(a), 6 or 10”.
Transitional Provision8.
Signed by authority of the Secretary of State for Wales
In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 22nd November 1990.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 22nd November 1990.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 22nd November 1990.
We consent,
SCHEDULE
Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
Provision in the principal Regulations | Subject matter | Old amount | New amount |
Regulation 4— | applications for clinical trial certificates | £13,600 | £20,000 |
Regulation 7— | variations of clinical trial certificates | £300 | £350 |
Regulation 8— | change of name and address in clinical certificates | £85 | £100 |
Regulation 11— | renewal of certificates | £3,400 | £5,000 |
Schedule 1— | |||
Part II— | fees for applications for licences | ||
Column 2 of the Table to paragraph 1— | |||
entry 1(a) | £13,600 | £20,000 | |
entry 1(b) | £68,000 | £130,000 | |
entry 2 | £10,200 | £20,000 | |
entry 3 | £5,100 | £10,000 | |
entry 4 | £2,550 | £3,000 | |
entry 5(a) | £2,550 | £3,000 | |
entry 5(b) | £1,700 | £2,000 | |
paragraph 4(1)(a) | £85 | £100 | |
paragraph 4(1)(b) | £1,700 | £1,955 | |
Part III— | fees for applications for variations of licences | ||
paragraph 1(a) | £2,125 | £2,000 | |
paragraph 1(b) | £300 | £350 | |
paragraph 2(a) | £85 | £100 | |
Part IV— | fees for applications for renewals of licences | ||
paragraph 1(b) | £850 | £800 | |
paragraph 1(c) | £1,275 | £1,200 | |
paragraph 1(d) | £850 | £800 | |
paragraph 2(a) | £85 | £100 | |
paragraph 2(b) | £850 | £1,000 | |
Schedule 2— | fees for inspections | ||
paragraph 2(a)(i) | £1,275 | £1,700 | |
paragraph 2(a)(ii) | £2,550 | £3,400 | |
paragraph 2(b)(i) | £2,125 | £2,750 | |
paragraph 2(b)(ii) | £4,250 | £5,500 | |
paragraph 2(d) | £85 | £100 |
These Regulations amend the Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989 which prescribe fees in connection with applications and inspections relating to licences and certificates granted under the Medicines Act 1968 so far as they apply to medicinal products for human use only and insert a transitional provision in respect of applications made by specified health authorities (regulation 8).
These regulations (regulation 2 and the Schedule) vary the fees payable for applications for the grant of product licences, manufacturers' licences, clinical trial certificates and export certificates, for variations of such licences or certificates and for their renewal. They also increase some of the fees payable in respect of inspections of sites carried out in connection with applications for, or during the currency of, such licences or certificates.
The regulations revoke the exemption from paying fees in respect of health authorities constituted for any part of the United Kingdom (regulation 3).
These regulations make various other amendments as follows:—
they insert a definition of qualified person (regulation 4) and widen the categories of variations of licences for which a reduced fee is payable (regulation 5);
they add a new category of inspection for the purpose of calculating fees (regulation 6);
they extend the provisions on waiver of fees (regulation 7).