The Medicines (Products for Animal Use—Fees) Regulations 1997

Interpretation

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

“abridged standard application” means an application for a marketing authorisation, other than a simple application which, by virtue of regulation 4(8) of the 1994 Regulations, need not be accompanied by the results of tests and trials of the type specified in Article 5.10 of Directive 81/851/EEC(1) because the applicant has demonstrated that he is entitled to the benefit of paragraph (a)(i), (ii) or (iii) of that Article;

“the Act” means the Medicines Act 1968(2);

“active ingredient” means the ingredient of a product in respect of which efficacy is claimed;

“application for assistance in connection with a mutual recognition application” means a request for the preparation of an assessment report of the type required by virtue of the second paragraph of Article 17.3 of Directive 81/851/EEC in order to make an application to another member State for mutual recognition of a marketing authorisation, or the updating of an existing assessment report for the purpose of enabling such an application to be made, and includes any assistance given of the type specified in Articles 18.2 and 18.3 of that Directive in connection with a subsequent application for mutual recognition in relation to which the assessment report or updated assessment report has been prepared;

“biological product” includes an antigen, toxin, antitoxin, toxoid, serum, antiserum or vaccine or a fraction of any such product;

“complex application” means an application, other than a major application for, or for a variation of, a marketing authorisation or product licence where the application—

(a)

relates to a product which is intended to be used in accordance with an indication for use in respect of a different species of animal or as treatment for a new medicinal purpose;

(b)

relates to a product containing a new combination of active ingredients which have not previously been included in that combination in a product in respect of which a marketing authorisation or product licence for animal use (other than product licence of right) has previously been granted in the United Kingdom;

(c)

relates to a product containing a new adjuvant or a new excipient;

(d)

relates to a product which is intended to be administered by a route of administration different from that used in the administration of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or a product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;

(e)

relates to a sterile product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;

(f)

relates to a product containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;

(g)

relates to a biological product containing an active ingredient, the manufacture of which involves a growth substrate different from that used in the manufacture of the active ingredient of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence has previously been granted in the United Kingdom;

(h)

relates to a product which is a controlled release preparation and a marketing authorisation or product licence for animal use (other than a product licence of right) for such a preparation constituting the same active ingredient as the product in question has not previously been granted in the United Kingdom;

(i)

relates to a sterile product the container of which is directly in contact with the product and is made from different a material from the container of any product which contains the same ingredient as the product in question and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom;

(j)

names as manufacturer of the active ingredient of the product in question a different manufacturer from the manufacturer of the active ingredient of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; or

(k)

relates to a biological product containing an active ingredient derived from a strain of micro-organism different from that used in the manufacture of the active ingredient of any product which contains the same active ingredient as the product in question and in respect of which a marketing authorisation or product licence has previously been granted in the United Kingdom;

“Directive 81/851/EEC” means Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products(3) as amended by Council Directives 90/676/EEC(4) and 93/40/EEC(5) and as extended by Directive 90/677/EEC(6) and widened by Directive 92/74/EEC(7);

“Directive 90/677/EEC” means Council Directive 90/677/EEC extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products;

“Directive 92/74/EEC” means Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homoeopathic veterinary medicinal products;

“EEA Agreement” means the Agreement on the European Economic Area(8) signed at Oporto on 2nd May 1992 as adjusted by the Protocol(9) signed at Brussels on 17th March 1993 and as amended by the Decision of the EEA Joint Committee No. 7/94(10);

“EEA State” means a State which is a Contracting Party to the EEA Agreement other than the United Kingdom;

“emergency vaccines” means vaccines manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated in circumstances in which no other suitable authorised or licensed vaccines are readily available for such use;

“immunological Veterinary Medicinal Product” has the same meaning as in the Directive 90/677/EEC;

“major application” means an application for a marketing authorisation or product licence in respect of a product containing a new active ingredient;

“marketing authorisation” means an authorisation to place on the market in the United Kingdom a Veterinary Medicinal Product but shall not include a marketing authorisation granted by the Community in accordance with the provisions of Council Regulation (EEC) No. 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(11);

“marketing authorisation (parallel import)” means a marketing authorisation granted by the Ministers in respect of a Veterinary Medicinal Product which is imported into the United Kingdom from another EEA State for which there has been granted a marketing authorisation by an EEA State and which has no different therapeutic effect from a Veterinary Medicinal Product for which a marketing authorisation has already been granted in the United Kingdom;

“medicinal product” includes any substances or article specified in any Order made under—

(a)

section 104 or 105(1)(a) of the Act which directs that Part II of the Act shall have effect in relation to such substance or article; or

(b)

section 130(3A) of the Act(12),

and includes any substance or article to be administered in a medicinal test on animals under section 32(6)(c) of the Act;

“the Ministers” has the meaning given by regulation 1(4) of the 1994 Regulations;

“mutually recognised marketing authorisation” means a marketing authorisation which has been mutually recognised by another member State;

“new active ingredient” means—

(a)

an active ingredient that has not previously been included as an active ingredient in a product in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom; or

(b)

an active ingredient in a product derived from genetically engineered micro-organisms, recombinant DNA technology or monoclonal antibodies; or

(c)

in the case of a biological product, a vaccine of a particular micro-organism whether in a live or inactivated form, other than a vaccine of a particular micro-organism which is derived from a strain of micro-organism which is antigenetically similar to that used in the manufacture of the active ingredient of a product in respect of which a marketing authorisation or product licence (not being a product licence of right) has previously been granted in the United Kingdom;

“new excipient” means any ingredient of a product, other than an active ingredient, that has not previously been included in a product—

(a)

which is intended to be administered by the same route of administration as that product; and

(b)

in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted in the United Kingdom,

except that, in the case of a product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation) as an approved ingredient or additive—

(i)

in food or food products; or

(ii)

in animal feedingstuffs where the product is intended for administration after being incorporated in the feedingstuff;

“product” means—

(a)

a Veterinary Medicinal Product, where it is used solely in relation to an application for, or relating to, a marketing authorisation; and

(b)

a medicinal product where it is used solely in relation to any other application;

except that, where it is used in relation to both an application for, or relating to, a marketing authorisation and any other application, it shall mean both a Veterinary Medicinal Product and a medicinal product;

“reference member State” has the meaning given by Article 2.2 of Regulation (EC) No. 541/95(13);

“Regulation (EC) No. 541/95” means Commission Regulation (EC) No. 541/95 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State;

“the 1994 Regulations” means the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(14);

“relevant authority” insofar as it is used in relation to a marketing authorisation, or an application for, or relating to, such an authorisation, means the Ministers, and otherwise means the licensing authority;

“simple application” means an application for a marketing authorisation or product licence when the application—

(a)

is made by reference to an application for a particular product (“the existing product”) in respect of which a marketing authorisation or product licence for animal use (other than a product licence of right) has previously been granted;

(b)

is made by permission of the marketing authorisation or licence holder for the existing product;

(c)

relates to a product which is in all the following respects the same as the existing product—

(i)

the formulation is identical;

(ii)

it is intended to be used in accordance with the same indications;

(iii)

it is intended to be administered by the same route of administration;

(iv)

the manufacturer named in the application is the same as the manufacturer of the existing product;

(v)

the method of manufacture is the same; and

(vi)

in the case of a sterile product the method of sterilisation is the same and the container which is directly in contact with the product is made from the same material;

“standard application” means an application which is not a major, complex, abridged standard or simple application; and

“Veterinary Medicinal Product” means a veterinary medicinal product of the type specified in Article 1.2 of Directive 81/851/EEC and to which the provisions of that Directive apply.

(2) Other expressions used in these Regulations have, in so far as the context admits, the same meanings as in Directive 81/851/EEC and Regulation (EC) No. 541/95.

(3) In these Regulations, unless the context otherwise requires—

(a) any reference to a numbered regulation or to a numbered Schedule is a reference to the regulation of or the Schedule to these Regulations so numbered in these Regulations;

(b) any reference in a regulation or a Schedule or Part of a Schedule to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule or Part of a Schedule in which the reference occurs; and

(c) any reference in a Schedule or Part of a Schedule to a lettered table is a reference to the table so lettered in the Schedule or Part of a Schedule in which the reference occurs.

(4) Part 1 of Schedule 1 shall have effect for the purpose of the interpretation of Schedule 1.

(1)

OJ No. L317, 6.11.81, p.1.

(2)

1968 c. 67.

(3)

OJ No. L317, 6.11.81, p.1.

(4)

OJ No. L373, 31.12.90, p.15.

(5)

OJ No. L214, 24.8.93, p.31.

(6)

OJ No. L373, 31.12.90, p.26

(7)

OJ No. L297, 13.10.92, p.12.

(8)

OJ No. L1, 3.1.94, p.3.

(9)

OJ No. L1, 3.1.94, p.572.

(10)

OJ No. L160, 28.6.94, p.1.

(11)

OJ No. L214, 24.8.93, p.1.

(12)

Section 130(3A) was inserted by section 13(2) of the Animal Health and Welfare Act 1984 (c. 40).

(13)

OJ No. L55, 11.3.95, p.7.

(14)

S.I. 1994/3142.