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

PART I INTERPRETATION

1.  In this Schedule—

“active ingredient” means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);

“complex application” means an application, other than a major application, for a marketing authorization where the application falls within one or more of the descriptions specified in sub-paragraphs (a) to (n)—

(a)

the application relates to a medicinal product which is intended to be used in accordance with an indication for use in respect of a new category of patients or as treatment for a new category of disease;

(b)

the application relates to a medicinal product containing a new combination of active ingredients that have not previously been included in that combination in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(c)

the application relates to a medicinal product containing a new excipient;

(d)

the application relates to a medicinal product that 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 marketing authorization (other than a product licence of right) has previously been granted;

(e)

the application 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 marketing authorization (other than a product licence of right) has previously been granted;

(f)

the application relates to a medicinal product which is a controlled release preparation and is not a simple application;

(g)

the application 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 marketing authorization (other than a product licence of right) has previously been granted;

(h)

the application 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 marketing authorization (other than a product licence of right) has previously been granted;

(i)

the application names as manufacturer of the active ingredient of the medicinal product in question a different manufacturer from the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(j)

the application relates to a medicinal product which is an influenza vaccine and in respect of which the manufacturer or the manufacturing process is different from that specified in any other marketing authorization which the applicant holds in respect of that product;

(k)

the application is for the grant of a marketing authorization for a medicinal product which is an influenza vaccine, except where it relates only to an influenza vaccine containing a different strain or strains from that specified in any other marketing authorization which the applicant holds;

(l)

the application is for the grant of a marketing authorization for a medicinal product which is to be delivered by way of a metered dose inhaler;

(m)

the application is for the grant of a marketing authorization for a medicinal product which is in a powdered form and is to be delivered by way of inhalation;

(n)

the application relates to a medicinal product

(i)

which is administered to the site of action or absorption by a method which has not previously been authorised in relation to any authorised medicinal product which contains the same active ingredient as the product in question and,

(ii)

in respect of that other product, a marketing authorization (other than a product licence of right) has previously been granted;

“decentralised incoming application” means a major application, a complex application or a standard application for a marketing authorization for a medicinal product in respect of which—

(a)

a marketing authorization has already been granted in another member State; and

(b)

recognition of that marketing authorization is sought from the licensing authority by way of the grant of a marketing authorization in the United Kingdom, pursuant to the procedure in Chapter III of Directive 75/319/EEC(1);

“major application” means an application relating to a medicinal product containing a new active ingredient;

“new active ingredient” means an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

“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 marketing authorization (other than a product licence of right) has previously been granted, 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 or in any Directive, Regulation or Decision of the European Community as an approved ingredient or additive in food or in a food product;

“simple application” means—

(a)

an application for a marketing authorization to which Article 4.8(a)(i) of Council Directive 65/65/EEC(2) applies other than one for a marketing authorization for a medicinal product which is a new strength of a product in respect of which a marketing authorization has previously been granted in the United Kingdom: or

(b)

an application, made no later than three months after the expiry of a marketing authorization, which is for a marketing authorization containing identical provisions to those contained in the expired authorization and which is made by the person who held the expired authorization;

“standard application” means any application for the grant of a marketing authorization which is not a major application, a complex application, a simple application, a change of ownership application or an application for a marketing authorization (parallel import).

(1)

OJ No. L147, 9.6.75. p. 13. Chapter III was replaced by Article 3 (1) of Directive 93/39/EEC (OJ No. L214, 24.8.93, p. 22).

(2)

OJ No. L22, 9.2.65, p. 369/65. The Directive was amended by Directives 75/319/EEC (OJ No. L147, 9.6.75, p.13); 83/570/EEC (OJ No. L332, 28.11.83, p. 1); 87/21/EEC (OJ No. L15, 17.1.87, p. 36); 89/341/EEC (OJ No. L142, 25.5.89, p.11); 89/343/EEC (OJ No. L142, 25.5.89, p. 16) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22).