COMMENTED by
The Medicines (Products for Human Use — Fees) Regulations 1995 (Note)

The Medicines (Products for Human Use — Fees) Regulations 1995

STATUTORY INSTRUMENTS

1995 No. 1116

MEDICINES

The Medicines (Products for Human Use -- Fees) Regulations 1995

Made 20th April 1995

Laid before Parliament 20th April 1995

Coming into force 21st April 1995

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, with the consent of the Treasury, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 1971[1], or, as the case may be, those conferred by the said provisions and now vested in them[2] and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations[3], hereby make the following Regulations:

PART I

GENERAL

Citation and commencement

1. These Regulations may be cited as the Medicines (Products for Human Use -- Fees) Regulations 1995 and shall come into force on 21st April 1995.

Interpretation

2. --(1) In these Regulations, unless the context requires otherwise--

"the Act" means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in the Act;

"the 1994 Regulations" means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994[4];

"authorised medicinal product" means a medicinal product in respect of which either a marketing authorization or marketing authorization (parallel import) has been granted;

"blood product" means any medicinal product derived from human blood or human plasma and includes albumin, coagulating factor and immunoglobulin of human origin;

"capital fee" means any fee, other than a periodic fee, payable under the provisions of these Regulations;

"change of ownership application" means an application for a marketing authorization for a medicinal product in respect of which a person other than the applicant is the holder of a marketing authorization and which--

(a) includes a statement to the effect that that other person intends to cease selling or supplying that product pursuant to that authorization;

(b) is signed by or on behalf of that other person, as well as by or on behalf of the applicant; and

(c) except for the name and address of the applicant and particulars in relation to the labelling of the product and any leaflet relating to it, contains, or is accompanied by, particulars which are in all material respects identical to the particulars referred to in the marketing authorization already held by that other person;

"Community marketing authorization" means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93[5];

"fee period" means the period beginning with the first day of April in any year and ending with the last day of March in the following year;

"immunological product" means any medicinal product which is a vaccine, toxin, serum or allergen product;

"manufacturer's licence" means a manufacturer's licence which relates wholly or partly to medicinal products for human use;

"marketing authorization" means--

(a) a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations;

(b) a Community marketing authorization; or

(c) a product licence, including one which is a licence of right or one which has effect as a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to the 1994 Regulations;which relates to a medicinal product for human use;

"marketing authorization (parallel import)" means a marketing authorization granted by the licensing authority in respect of a medicinal product which is imported into the United Kingdom from another member State of the European Community, in respect of which t...

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