The Medicines (Products for Human Use) (Fees) Regulations 2012

Standard variation application for a homoeopathic medicinal product

21.  A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorization for a national homoeopathic product which requires—

(a) the replacement of an excipient used in the manufacture of the product;

(b) the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;

(c) a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;

(d) a change to the method of manufacture of a homoeopathic stock included in the product;

(e) a change to the specification of any reagent or excipient used in the manufacture of the product;

(f) a change to the finished product specification of the product;

(g) a change to the test procedure for any raw material used in the manufacture of the product;

(h) a change to the test procedure for the product;

(i) a change to the test procedure for the container or other form of packaging immediately in contact with the product;

(j) a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a Member State;

(k) a change to the shape of the container in which the product may be placed on the market;

(l) an additional pack size in which the product may be placed on the market;

(m) a change to the approved storage conditions for the product;

(n) a change to the shelf life of an unopened container of the product after the container has been opened for the first time;

(o) a change to the dimensions of an approved dosage form of the product (for example, tablets); or

(p) a change following modification to the manufacturing authorization referred to in Article 40 of the 2001 Directive.