The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989

PART I interpretation

1.  In this Schedule–

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

“biological medicinal product” includes an antigen, toxin, antitoxin, serum, antiserum or vaccine;

“complex application” means an application, other than a major application, for a product licence or, as the case may be, for a variation to a product licence where the application–

(a)

is subject to the procedure laid down in Article 17 of Council Directive 81/851/EEC(1) (notification to five or more Member States);

(b)

relates to a medicinal 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;

(c)

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

(d)

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

(e)

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

(f)

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

(g)

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

(h)

relates to a biological medicinal 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 medicinal product which contains the same active ingredient as the product in question and in respect of which a product licence has previously been granted in the United Kingdom;

(i)

relates to a medicinal product which is a controlled release preparation and a 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;

(j)

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

(k)

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

(l)

relates to a biological medicinal 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 medicinal product which contains the same active ingredient as the product in question and in respect of which a product licence has previously been granted in the United Kingdom;

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

“new active ingredient” means–

(a)

an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a 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 medicinal product derived from genetically engineered micro-organisms, recombinant DNA technology or monoclonal antibodies; or

(c)

in the case of a biological medicinal product, a vaccine of a particular micro-organism whether in a live or inactivated form, but this does not include 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 medicinal product in respect of which a product licence (not being a product licence of right) has previously been granted in the United Kingdom;

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

(a)

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

(b)

in respect of which a 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 medicinal 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 that product is intended for administration after being incorporated in the feedingstuff;

“simple application” means an application for a 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 product licence for animal use (other than a product licence of right) has previously been granted;

(b)

is made by permission of the 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)

it contains the same combination of active ingredients;

(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;

(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–

(d)

any application in respect of a medicinal product for animal use specified in Annex 1 of Council Directive 70/524/EEC(2) or made pursuant to the Medicines (Exportation of Specified Veterinary Products) Order 1971(3), which is not a simple application;

(e)

any other application which is not a major, complex or simple application.

(1)

O.J. No. L317, 28.9.81 p.1.

(2)

O.J. No. L270, 23.11.70 p. 1, as amended by Council Directive 84/587/EEC, O.J. No. L319, 8.12.84 p. 13.

(3)

S.I. 1971/1309.