The Medicines (Products for Animal Use—Fees) Regulations 1998

PART I INTERPRETATION

In this Schedule, unless the context requires otherwise–

“abridged standard application” means an application for a marketing authorisation 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 but does not include a simple application or an emergency vaccine application;

“active ingredient” means the ingredient of a product in respect of which efficacy is claimed in an application to which this Schedule relates;

“application for a type A marketing authorisation” means an application for a marketing authorisation to which regulation 5(a) of the 1994 Regulations applies;

“application for a type B marketing authorisation” means an application for a marketing authorisation to which regulation 5(b) of the 1994 Regulations applies;

“Article 15.2 marketing authorisation” means a marketing authorisation of the type specified in Article 15.2 of Directive 81/851/EEC;

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

“Category I application” means an application for assistance in connection with a mutual recognition application other than a Category II or III application;

“Category II application” means an application, other than a Category III application, for assistance in connection with a mutual recognition application relating to a marketing authorisation granted in respect of a Veterinary Medicinal Product only intended for administration to animals whose flesh or products are not intended for human consumption;

“Category III application” means an application for assistance in connection with a mutual recognition application relating to a marketing authorisation granted in respect of an immunological Veterinary Medicinal Product;

“complex application” means an 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–

(i)

in accordance with an indication for use in respect of a species of animal, or

(ii)

as a treatment for a medicinal purpose,

for which it has not previously been used;

(b)

relates to a product containing a 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 a product licence of right) has previously been granted in the United Kingdom;

(c)

relates to a product containing 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–

(i)

which contains the same active ingredient as the product in question, and

(ii)

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–

(i)

which contains the same active ingredient as the product in question, and

(ii)

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–

(i)

which contains the same active ingredient as the product in question, and

(ii)

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–

(i)

which contains the same active ingredient as the product in question and

(ii)

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 in circumstances where 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) which is made from a material different from that used for the container of any product–

(i)

which contains the same ingredient as the product in question and

(ii)

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 manufacturer different from the manufacturer of the active ingredient of any product–

(i)

which contains the same active ingredient as the product in question, and

(ii)

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–

(i)

which contains the same active ingredient as the product in question, and

(ii)

in respect of which a marketing authorisation or product licence has previously been granted in the United Kingdom, but does not include a major application or an emergency vaccine application;

“emergency vaccine” means a vaccine 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;

“emergency vaccine application” means an application, limited to use of an emergency vaccine, for a marketing authorisation or product licence;

“excipient”, in relation to an immunological Veterinary Medicinal Product, includes an adjuvant;

“food-producing animals” means animals whose flesh or products are intended for human consumption;

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

“individual variation” means, in relation to an application to vary (or renew with variations)–

(a)

a mutually recognised marketing authorisation, a variation covered by any single numbered paragraph of Annex I to Regulation (EC) No. 541/95; and

(b)

any other authorisation or licence or certificate, any element in the application which calls for a separate assessment in order to reach a decision whether the application should be granted; “marketing authorisation (parallel import)” means a marketing authorisation granted by the Ministers in respect of a Veterinary Medicinal Product–

(c)

which is imported into the United Kingdom from an EEA State,

(d)

for which there has been granted a marketing authorisation by an EEA State, and

(e)

which has no therapeutic effect different from that of a Veterinary Medicinal Product for which a marketing authorisation has already been granted in the United Kingdom;

“major application” means an application for a marketing authorisation or product licence in respect of a product containing a new active ingredient but does not include an emergency vaccine application;

“member State” means a member State other than the United Kingdom;

“mutually recognised marketing authorisation” means a marketing authorisation which has been mutually recognised by a 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 where the product is 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”, in relation to a product containing it, means any ingredient which–

(a)

is not an active ingredient,

(b)

has not previously been included in a product of a different description–

(i)

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

(ii)

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

(c)

if the product containing it is intended to be administered orally, is not specified in any Act or subordinate legislation as able to be used lawfully as an ingredient of or additive for–

(i)

food for human consumption in any event; or

(ii)

animal feedingstuffs, in any case where the product containing it is intended for administration after being incorporated in an animal feedingstuff;

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

“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 with the permission of the marketing authorisation or licence holder for the existing product; and

(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;

but does not include an emergency vaccine application.

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

“Type I variation–Administrative” means a variation of a type listed in variations 2 and 3 of Annex I to Regulation (EC) No. 541/95;

“Type I variation–Scientific” means a variation of a type listed in variations 1 and 4 to 33 of Annex 1 to Regulation (EC) No. 541/95;

“Type I variation, Scientific–Type II procedure” means a variation within the derogation, insofar as it relates to products falling within the scope of Directive 90/677/EEC, in introductory statement A of Annex 1 to Regulation (EC) No. 541/95; and

“Type II variation” means a variation of the type referred to in Article 3.1(b) of Regulation (EC) No. 541/95.